Posts Tagged ‘Public–private partnership’

Real Time Coverage @BIOConvention #BIO2019: June 4 Morning Sessions; Global Biotech Investment & Public-Private Partnerships

Reporter: Stephen J Williams PhD @StephenJWillia2

Each country have their own needs and most important drug cost structure. Must involve patients and providers.
BCI survey: countries output different, who improved who didnt
Is industry having collaboration with government? hardly ten percent by survey and worse vice versa
Transparancy and holistic view important for collaboration
Korea: lack of communication need input from government on pricing; wants global open innovation and enhance RD investments
Tawain: price, price but based on efficacy; pharma needs to talk with doctors hospital patients, find balance
Pitts: we need trust; staff that country offices with people who know that country. Price not defining value
Columbia:  need to attract investors

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Real Time Coverage @BIOConvention #BIO2019:  Issues of Risk and Reproduceability in Translational and Academic Collaboration; 2:30-4:00 June 3 Philadelphia PA

Reporter: Stephen J. Williams, PhD @StephenJWillia2

Derisking Academic Science: The Unmet Need  

Translating academic research into products and new therapies is a very risky venture as only 1% of academic research has been successfully translated into successful products.

Collaboration from Chicago area universities like U of Chicago, Northwestern, etc.  First phase was enhance collaboration between universities by funding faculty recruitment and basic research.  Access to core facilities across universities.  Have expanded to give alternatives to company formation.
Half of the partnerships from Harvard and companies have been able to spin out viable startups.
Most academic PI are not as savvy to start a biotech so they bring in biotechs and build project teams as well as developing a team of ex pharma and biotech experts.  Derisk as running as one asset project.  Partner as early as possible.  A third of their pipeline have been successfully partnered.  Work with investors and patent attorneys.
Focused on getting PIs to get to startup.  Focused on oncology and vaccines and I/O.  The result can be liscensing or partnership. Running around 50 to 60 projects. Creating a new company from these US PI partnerships.
Most projects from Harvard have been therapeutics-based.  At Harvard they have a network of investors ($50 million).   They screen PI proposals based on translateability and what investors are interested in.
In Chicago they solicit multiple projects but are agnostic on area but as they are limited they are focused on projects that will assist in developing a stronger proposal to investor/funding mechanism.
NYU goes around university doing due diligence reaching out to investigators. They shop around their projects to wet their investors, pharma appetite future funding.  At Takeda they have five centers around US.  They want to have more input so go into the university with their scientists and discuss ideas.

Takeda: Data Validation very important. Second there may be disconnect with the amount of equity the PI wants in the new company as well as management.  Third PIs not aware of all steps in drug development.

Harvard:  Pharma and biotech have robust research and academic does not have the size or scope of pharma.  PIs must be more diligent on e.g. the compounds they get from a screen… they only focus narrowly

NYU:  bring in consultants as PIs don’t understand all the management issues.  Need to understand development so they bring in the experts to help them.  Pharma he feels have to much risk aversion and none of their PIs want 100% equity.

Chicago:  they like to publish at early stage so publication freedom is a challenge

Dr. Freedman: Most scientists responding to Nature survey said yes a reproduceability crisis.  The reasons: experimental bias, lack of validation techniques, reagents, and protocols etc.
And as he says there is a great ECONOMIC IMPACT of preclinical reproducability issues: to the tune of $56 billion of irreproducable results (paper published in PLOS Biology).  If can find the core drivers of this issue they can solve the problem.  STANDARDS are constantly used in various industries however academic research are lagging in developing such standards.  Just the problem of cell line authentication is costing $4 billion.
Dr. Cousins:  There are multiple high throughput screening (HTS) academic centers around the world (150 in US).  So where does the industry go for best practices in assays?  Eli Lilly had developed a manual for HTS best practices and in 1984 made publicly available (Assay Guidance Manual).  To date there have been constant updates to this manual to incorporate new assays.  Workshops have been developed to train scientists in these best practices.
NIH has been developing new programs to address these reproducability issues.  Developed a method called
Ring Testing Initiative” where multiple centers involved in sharing reagents as well as assays and allowing scientists to test at multiple facilities.
Dr.Tong: Reproduceability of Microarrays:  As microarrays were the only methodology to do high through put genomics in the early 2000s, and although much research had been performed to standardize and achieve best reproduceability of the microarray technology (determining best practices in spotting RNA on glass slides, hybridization protocols, image analysis) little had been done on evaluating the reproducibility of results obtained from microarray experiments involving biological samples.  The advent of Artificial Intelligence and Machine Learning though can be used to help validate microarray results.  This was done in a Nature Biotechnology paper (Nature Biotechnology volume28pages827–838 (2010)) by an international consortium, the International MAQC (Microarray Quality Control) Society and can be found here
However Dr. Tong feels there is much confusion in how we define reproduceability.  Dr. Tong identified a few key points of data reproduceability:
  1. Traceability: what are the practices and procedures from going from point A to point B (steps in a protocol or experimental design)
  2. Repeatability:  ability to repeat results within the same laboratory
  3. Replicatablilty:  ability to repeat results cross laboratory
  4. Transferability:  are the results validated across multiple platforms?

The panel then discussed the role of journals and funders to drive reproduceability in research.  They felt that editors have been doing as much as they can do as they receive an end product (the paper) but all agreed funders need to do more to promote data validity, especially in requiring that systematic evaluation and validation of each step in protocols are performed..  There could be more training of PIs with respect to protocol and data validation.

Other Articles on Industry/Academic Research Partnerships and Translational Research on this Open Access Online Journal Include

Envisage-Wistar Partnership and Immunacel LLC Presents at PCCI

BIO Partnering: Intersection of Academic and Industry: BIO INTERNATIONAL CONVENTION June 23-26, 2014 | San Diego, CA

R&D Alliances between Big Pharma and Academic Research Centers: Pharma’s Realization that Internal R&D Groups alone aren’t enough

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Envisage-Wistar Partnership and Immunacel LLC Presents at PCCI

Reporter: Stephen J. Williams, PhD

The Pharmaceutical Consulting Consortium International (PCCI) June Meeting: Envisage-Wistar Partnership and Immunacel LLC

An early stage healthcare venture creation and management firm

Presenter: Vic Subbu, COO of Immunacel & Managing Partner of Envisage and Heather Steinman, VP of Business Development & Executive Director Tech Transfer Wistar Institute

Monday, June 8, 2015

Embassy Suites, Chesterbrook, Pennsylvania (directions)

Announcement from the PCCI website:

Much has been said lately about how to improve the tech transfer situation. Wistar is meeting this challenge. Immunacel is the first of a series of developmental challenges and the Envisage-Wistar partnership solution becomes the meat of the evening’s discussion.

The Wistar Institute is the nation’s first independent institution devoted to medical research and training. The Wistar Institute has evolved from its beginnings as an anatomical teaching museum to its present-day status as an international leader in basic biomedical research.

Envisage LLC is an early stage healthcare venture creation and management firm. By focusing on key healthcare segments, Envisage aims to identify and advance promising healthcare innovations into value-add ventures.

IMMUNACCEL LLC is a Wistar Institute spin-out focused on accelerating the development of immune-mediated treatments for cancer and other unmet medical needs:

MMUNACCEL’s 3-D cancer-immune cell organotypic culture system is a physiologically relevant culture system utilizing primary human cancer cells and cytotoxic T cells (CTL) generated from patient T-cells, amongst fibroblasts and collagen assembled in a 3-D organotypic model.

Other related articles on PCCI and Philadelphia Biotech were published in this Open Access Online Scientific Journal, include the following:

PCCI’s 7th Annual Roundtable “Crowdfunding for Life Sciences: A Bridge Over Troubled Waters?” May 12 2014 Embassy Suites Hotel, Chesterbrook PA 6:00-9:30 PM

Protecting Your Biotech IP and Market Strategy: Notes from Life Sciences Collaborative 2015 Meeting

The Vibrant Philly Biotech Scene: Focus on KannaLife Sciences and the Discipline and Potential of Pharmacognosy

The Vibrant Philly Biotech Scene: Focus on Computer-Aided Drug Design and Gfree Bio, LLC

The Vibrant Philly Biotech Scene: Focus on Vaccines and Philimmune, LLC

The Bioscience Crowdfunding Environment: The Bigger Better VC?

R&D Alliances between Big Pharma and Academic Research Centers: Pharma’s Realization that Internal R&D Groups alone aren’t enough

BIO Partnering: Intersection of Academic and Industry: BIO INTERNATIONAL CONVENTION June 23-26, 2014 | San Diego, CA

Diagnostics and Biomarkers: Novel Genomics Industry Trends vs Present Market Conditions and Historical Scientific Leaders Memoirs

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8:00AM 11/13/2014 – 10th Annual Personalized Medicine Conference at the Harvard Medical School, Boston

REAL TIME Coverage of this Conference by Dr. Aviva Lev-Ari, PhD, RN – Director and Founder of LEADERS in PHARMACEUTICAL BUSINESS INTELLIGENCE, Boston http://pharmaceuticalintelligence.com

8:00 A.M. Welcome from Gary Gottlieb, M.D.

Opening Remarks:

Partners HealthCare is the largest healthcare organization in Massachusetts and whose founding members are Brigham and Women’s Hospital and Massachusetts General Hospital. Dr. Gottlieb has long been a supporter of personalized medicine and he will provide his vision on the role of genetics and genomics in healthcare across the many hospitals that are part of Partners HealthCare.

Opening Remarks and Introduction

Scott Weiss, M.D., M.S. @PartnersNews
Scientific Director, Partners HealthCare Personalized Medicine;
Associate Director, Channing Laboratory/
Professor of Medicine, Harvard Medical School 


Engine of innovations

  • lower cost – Accountable care
  • robust IT infrastructure on the Unified Medical Records
  • Lab Molecular Medicine and Biobanks
  • 1. Lab Molecular medicine
  • 2. Biobank
  • 3. Translations Genomics: RNA Sequencing
  • 4. Medical Records integration of coded diagnosis linked to Genomics

BIOBANKS – Samples and contact patients, return actionable procedures

LIFE STYLE SURVEY – supplements the medical record

GENOTYPING and SEQUENCING – less $50 per sequence available to researcher / investigators

RECRUITMENT – subject to biobank, own Consents – e-mail patient – consent online consenting — collects 16,000 patients per month – very successful Online Consent

LAB Molecular Medicine – CLIA — genomics test and clinical care – EGFR identified as a bio-marker to cancer in 3 month a test was available. Best curated medical exon databases Emory Genetics Lab (EMVClass) and CHOP (BioCreative and MitoMAP and MitoMASTER). Labs are renowned in pharmacogenomics and interpretability.

IT – GeneInsight – IT goal Clinicians empowered by a workflow geneticist assign cases, data entered into knowledge base, case history, GENEINSIGHT Lab — geneticists enter info in a codified way will trigger a report for the Geneticist – adding specific knowledge standardized report enters Medical Record. Available in many Clinics of Partners members.

Example: Management of Patient genetic profiles – Relationships built between the lab and the Clinician

Variety of Tools are in development

GenInsight Team –>> Pathology –>> Sunquest Relationship

The Future

Genetic testing –>> other info (Pathology, Exams, Life Style Survey, Meds, Imaging) — Integrated Medical Record

Clinic of the Future-– >> Diagnostics – Genomics data and Variants integrated at the Clinician desk

Gary Gottlieb, M.D. @PartnersNews
President and CEO, Partners HealthCare

Translational Science
Partners 6,000 MDs, MGH – 200 years as Teaching Hospital of HMS, BWH – magnets in HealthCare

2001  – Center for Genomics was started at Partners, 2008 Genomics and Other Omis, Population Health, PM – Innovations at Partners.

Please Click on Link  Video on 20 years of PartnersHealthcare

Video of Dr. Gottlieb at ECRI conference 2012

Why is personalized medicine  important to Partners?

From Healthcare system to the Specific Human Conditions

  • Lab translate results to therapy
  • Biobank +50,000 specimens links to Medical Records of patients – relevant to Clinician, Genomics to Clinical Applications

Questions from the Podium

  • test results are not yet available online for patients
  • clinicians and liability – delays from Lab to decide a variant needs to be reclassified – alert is triggered. Lab needs time to accumulated knowledge before reporting a change in state.
  • Training Clinicians in above type of IT infrastructure: Labs around the Nations deal with VARIANT RECLASSIFICATION- physician education is a must, Clinicians have access to REFERENCE links.
  • All clinicians accessing this IT infrastructure — are trained. Most are not yet trained
  • Coordination within Countries and Across Nations — Platforms are Group specific – PARTNERS vs the US IT Infrastructure — Genomics access to EMR — from 20% to 70% Nationwide during the Years of the Obama Adm.
  • Shakeout in SW linking Genetic Labs to reach Gold Standard

Click to see Advanced Medical Education Partners Offers


– See more at: http://personalizedmedicine.partners.org/Education/Personalized-Medicine-Conference/Program.aspx#sthash.qGbGZXXf.dpuf









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FDA Pending 510(k) for The Latest Cardiovascular Imaging Technology

Curator: Aviva Lev-Ari, PhD, RN


UPDATED on 11/22/2018

  • Device Approvals, Denials and Clearances


  • FDA clears AI technology that evaluates echocardiograms – Ultrasound Images


  • Heart Murmur Detection done by AI Algorithm (Eko Core and Eko Duo) Devices Outperform most Auscultatory Skills of Cardiologists


  • FDA Clears Remote Multichannel ECG Compared to Holter


  • Arterys Cardio AI – MR Images

Arterys CEO Fabien Beckers, along with Michael Poon, MD, Northwell Health cardiologist, will present “The Potential of a Web Platform to Transform Medical Imaging with AI and Cloud Computation” in the 2018 RSNA Machine Learning Showcase, Tuesday November 27 at 11:30am CST. Arterys will provide demonstrations of its AI-powered, web-based solutions, including:

Arterys Cardio AIMR combines the power of deep learning and cloud computing to automate analysis of cardiac MR images. By eliminating many tedious, manual tasks, Arterys Cardio AI enables clinicians to quickly and easily identify, determine treatment for and track heart problems. It is the first and only commercial solution to offer deep learning-based semi-quantitative perfusion and quantitative delayed enhancement analysis*.


  • AI software for detecting brain bleeds receives FDA approval – CT Images

The FDA recently administered 510(k) clearance to software developed by MaxQ AI that uses AI to detect brain bleeds on CT images, according to a report published Nov. 8 by AI in Healthcare.  

“The Accipio Ix Intracranial Hemorrhage platform uses AI technology to automatically analyze non-contrast head CT images, and can do so without impacting a physician’s workflow, altering the original series or storing protected health information,” according to the article.

The clinical diagnostics intelligence platform company hopes that the software can help physicians prioritizes patients who show symptoms of brain bleeds.

With FDA approval, the AI software can be sold for commercial use within the U.S. and will be on display during this year’s Radiological Society of North America (RSNA) Annual Meeting in Chicago.



  • More in Artificial Intelligence



Cardiovascular Medical Devices in the News

March 13, 2018 — Determining the best occluder device size necessary to properly seal the left atrial appendage (LAA) before implanting the device may be feasible with the assistance of 3D printing, according to two separate presentations at ECR 2018 in Vienna.



  • Machine learning can help assess atherosclerosis
    February 7, 2018 — Machine-learning techniques analyze imaging measurements to automatically stratify patients by the level of atherosclerotic burden, offering the potential of personalized prediction of disease progression and more effective treatment for individual patients, according to researchers from Italy.  Discuss



  • CCTA biomarker may predict mortality from heart disease
    August 28, 2018 — The use of coronary CT angiography (CCTA) to measure fatty tissue around arteries could help predict the risk of mortality from heart disease, according to research published online on 28 August in the Lancet and being presented at the European Society of Cardiology congress in Munich.  Discuss



  • SCOT-HEART: CCTA cuts risk of heart attack, death by 41%
    August 25, 2018 — Patients with chest pain who underwent coronary CT angiography (CCTA) with standard care had a markedly lower rate of myocardial infarction or death from coronary artery disease than those who only received standard care in a new study, published on August 25 in theNew England Journal of Medicine.  Discuss







FDA’s Medical Devices Frontier in 2013

Michelle McMurry-Heath

Office of the Center Director, Center for Devices and

Radiological Health, U.S. Food and Drug Administration (FDA)


Margaret A. Hamburg

Office of the Commissioner, FDA

In their article Creating a Space for Innovative Device Development stated that the FDA announces a partnership with a new nonprofit organization—the Medical Device Innovation Consortium (MDIC) —to advance regulatory science in the medical technology arena.

The promise of MDIC is to eliminate the currently existing shortfalls in applied research in areas such as health-related engineering and regulatory science, which comprises the development of new tools, standards, and approaches to assess a product’s safety, efficacy, quality, and performance.

MDIC will foster regulatory science breakthroughs in the medical technology space with the ultimate goal of improving human health.

FDA and LifeScience Alley (LSA; https://www.lifesciencealley.org)—a biomedical science trade association—have worked together to develop the first medical device public-private partnership (PPP) whose sole objective is to advance the entire spectrum of regulatory science in this sector. MDIC will facilitate this groundbreaking collaboration among federal agencies, nonprofit organizations, industry, academic institutions, and other trade associations such as MassMedic (www.massmedic.com) and the California Healthcare Institute (www.chi.org). Key goals:

(1) encourage members to leverage their resources by focusing jointly on precompetitive

(2) early-stage technology development ef orts that otherwise would not take place because of the organizational structure of the device sector.

About 75% of the more than 5,000 device manufacturers in the United States are small companies with fewer than 20 employees (3).

Start-up device companies have limited capital, and a startup’s future of en depends on the success of one complex device. Advances in regulatory science would speed the translation of these next-generation technologies.

Medical Devices sector lacks the resources to support regulatory science research, as well as mechanisms for working together to pool their resources to solve scientific issues.

MDIC members will make it a priority to develop regulatory methods and tools that can be adopted by the medical device community and will provide a forum for medical device stakeholders to securely share proprietary precompetitive data. Each advance achieved by medical device stakeholders through the sharing and leveraging of resources will assist industry in developing new REGULATORY SCIENCE Creating a Space for Innovative Device Development.


MDIC was designed with f exibility in mind, so that it can adapt to address the most pressing needs of patients and of the device industry as they evolve over time.

In keeping with the goal of stakeholder engagement, MDIC is currently recruiting founding members who will work jointly with FDA to determine research priorities for the endeavor.

Much like other successful PPPs in the pharmaceutical space, such as the Foundation for NIH or Critical Path Institute, the founding members will be asked to represent their stakeholder communities in

(i) suggesting the most promising areas for research collaboration,

(ii) raising funds to support these areas of investigation, and then

(iii) issuing requests for grant proposals.

Researchers and engineers from all sectors—industry, government, academia, or nonprofit organizations—will be encouraged to apply, and preference will be given to research consortia that cross sectors and take interdisciplinary approaches to problems.

MDIC strives to support science conducted by research teams that have innovative ideas for the development of tools and methods for medical device design, testing, and regulatory approval.

MDIC’s potential to improve patient care is computational modeling and simulation of human pathophysiology, which can be used to augment in vitro and animal disease models in the preclinical stages of device development.

FDA’s Center for Devices and Radiological Health (CDRH) expects computational modeling to accelerate and streamline the regulatory review process but first needs to develop a strategy for assessing the technology’s credibility—its usefulness, quality, and reproducibility. CDRH has begun to develop a technological framework called the Virtual Physiological Patient (4), which, once completed, will provide a model for the human body as a single complex system. 

However, cross-sector research teams are required to develop the normal and diseased reference models that will serve as benchmarks for device performance and safety. Using computational modeling and simulation, device designs can potentially be ref ned even before they enter clinical trials, improving safety for patients and reducing the cost of device development for companies, computational modeling and simulation, device designs can potentially be ref ned even before they enter clinical trials, improving safety for patients and reducing the cost of device development for companies.

Another emerging research area is medical device interoperability—the development of devices that seamlessly operate with other medical devices and information systems (5). MDIC could establish a framework to identify gaps in the interoperability field, prioritize the gaps, and then fund research accordingly.

MDIC also could help prioritize the development of standards for innovative interoperable medical devices and build test beds for these technologies. is research will help to ensure that interoperability issues do not pose a hazard to patients.

With the emergence of new materials in medical devices, FDA must develop updated biocompatibility standards based on the most recent scientific advances.

MDIC could support the development of new preclinical biocompatibility assays that predict potential adverse health responses in people exposed to biomaterials or nanoparticles (6).

INNOVATION INFRASTRUCTURE With today’s fiscal realities, FDA cannot rely on government-funded “Manhattan projects” to bridge the funding gap for regulatory science. Partnerships bring together private-sector expertise, academic science ingenuity, and federal regulatory knowledge, and new structures are needed to promote these multifaceted collaborations.

It would be convenient if such partnerships formed organically, but all too of en, bureaucratic red tape gets in the way of sensible scientif c collaboration. MDIC will serve as a collaborative freeway to biomedical discovery and development by forming a foundation that makes it easy for industry, academia, and government to come together to set research priorities; to pool their distinct intellectual capital; and then to work together to advance knowledge that modernizes regulatory science and improves patient access to high-quality medical technology.

Sci. Transl. Med. 4, 163fs43 (2012)

[ScienceTranslationalMedicine.org 5 December 2012 Vol 4 Issue 163 163fs43]

Statistics on Device use — Number of procedures in the United States (2009)

Number of domestic inpatient procedures (N = 48 million per year)

  • Insertion of coronary artery stent: 528,000
  • Diagnostic ultrasound: 902,000
  • CT scan: 497,000
  • Arteriography and angiocardiography: 1.9 million
  • Cardiac catheterization: 1.1 million
  • Total hip replacement: 327,000
  • Total knee replacement: 676,000


U.S. Centers of Disease Control www.cdc.gov/nchs/fastats/insurg.htm

This sector is best known for

  • surgical instruments,
  • cardiology devices, and
  • orthopedic implants, it also includes all of the
  • diagnostic tests and
  • imaging equipment currently used to pinpoint disease 
  • companion diagnostics, which are needed to fulfill the promise of personalized medicine (1).

FDA 510 (k) Pending for the Latest Cardiovascular Imaging Technology

Editor’s choice of the most innovative technology at RSNA 2012

Dave Fornell

December 11, 2012
Toshiba is developing a radiation dose alert to show interventionalists how much dose they have delivered to their patient from X-ray angiography.
 The latest advances in cardiovascular imaging are usually shown first at the Radiological Society of North America (RSNA) annual meeting, the largest radiology show in the world, held the last week of November in Chicago. After spending five days walking three expo halls filled with more than 600 product vendors, the following is my editor’s choice for the most innovative new cardiovascular imaging technology.

New Angiography Systems

Siemens unveiled two new 510(k)-pending angiography systems, the Artis Q and Artis Q.zen, which incorporate new X-ray tube, detector and imaging software technology that can help reduce dose significantly, while offering improved image quality.

The new X-ray tube is intended to help physicians identify small vessels up to 70 percent better than conventional X-ray tube technology. The Artis Q.zen combines this innovative X-ray source with a new detector technology designed to support interventional imaging in ultra low-dose ranges to patients, doctors and medical staff, particularly during more complex, longer interventions.

The second generation of Siemens’ flat emitter technology replaced the coiled filaments used in conventional X-ray tubes to emit electrons. Flat emitters are designed to enable smaller quadratic focal spots that lead to improved visibility of small vessels.

The Artis Q.zen combines the X-ray tube with a detector technology that allows detection at ultra-low radiation levels. It can image with doses as low as half the standard levels applied in angiography. Instead of detectors based on amorphous silicon, a new crystalline silicon structure of the Artis Q.zen detector is designed to be more homogenous, allowing for more effective amplification of the signal, greatly reducing the electronic noise.

Siemens also introduced new software applications for interventional imaging. Clear Stent Live freezes an enhanced image of a stent during deployment with the balloon radio-opaque markers and uses it as an overlay on live fluoroscopy. Siemens says the main application will be for better visualization when implanting overlapping stents or stenting bifurcation lesions. It also helps suppress and stabilize heart motion on the image.

Other new 3-D applications are designed to image the smallest structures inside the head. Their high spatial resolution is crucial for imaging intracranial stents or other miniscule structures such as the cochlea in the inner ear. Moving organs such as the lungs can be imaged in 3-D in less than three seconds, reducing motion artifacts and the required amount of contrast agent.

GE Healthcare showcased its IGS (Image Guided System) 750 hybrid OR angiography system. It was displayed at RSNA 2011, but did not receive FDA clearance until earlier this year. It offers the mobility of a mobile C-arm, but the image quality and software features of a ceiling or floor mounted fixed system. It uses laser guidance for very accurate positioning. It can rove around the room on a powered caster system to enable different positioning around the table, or be parked out of the way during open surgical procedures.

Hands-Free Physician Control of Images

GestSure displayed a new, FDA-cleared system that allows interventionalists in the cath lab, or surgeons in the operating room, to pick reference images to display on the overhead screens in the room and manipulate the images all hands-free. It allows physicians to pick and enlarge the images they need for better procedural navigation, while maintaining the sterile field.

A video sensor detects all the people in the work area and displays their outlines on a separate screen, with each person assigned a specific color. When one of those people raises their arms in the “hands up” pose, the system detects this and allows the person control of the system. Using the right arm/hand, they can scroll through images and use the left arm/hand as a mouse click by a pushing motion forward. The system detects the motions and translates them in real time to mouse actions on the overhead screen.

The software works as a vendor-neutral layer on top of existing PACS or advanced visualization software.

Outpatient, Office-Based Catheter Interventions

Outpatient, office-based peripheral vascular procedures are an increasing trend, according to GE healthcare, which showcased a new “mobile hybrid OR” solution. The trend includes setting up an outpatient cath lab in an office setting to reduce the costs of using hospital ORs or cath labs. The room system GE highlighted centers around its OEC 9900 Elite mobile C-arm and Venue 40, which is combined with a ultrasound system in an all-in-one unit. The GE Venue 40 tablet ultrasound system is mounted within the OEC 9900 Elite C-arm’s workstation to reduce the floor space required.

Wireless Ultrasound Transducer

Siemens introduced the world’s first wireless transducer ultrasound system, the Acuson Freestyle. It eliminates the impediment of cables in ultrasound imaging by using a battery-powered transducer, about the size of a large TV controller. The transducer can be submerged for cleaning. It is capable of 90 minutes of continuous scanning before the battery needs to be recharged.

The Freestyle is a point-of-care system that will expand ultrasound’s use in interventional and therapeutic applications. The transducer can be used to image up to 10 feet from the console. Siemens said it hopes to refine and expand the wireless transducer technology to its other systems in the coming years.

Engineers had to overcome several issues to create a wireless transducer. For example, a cardiac echo requires about 40 frames per second and each frame is equal to about 1 megabyte of data. To accommodate the amount of data and speed the computer processing involved, some of the electronics are placed in the transducer rather than processing the data in the machine console. The wireless system transmits the data over an 8 GHz ultrawideband radio frequency to the console. The amount of data and the bandwidth transmitted by the transducer is equal to about 10 4G smart phones working continuously.

Noiseless MRI

GE Healthcare introduced its 510(k)-pending noiseless MRI Silent Scan technology that it hopes to introduce in 2013 for its MR450W 1.5T system. The technology addresses one of the most significant impediments to patient comfort — excessive noise generated during the exam that can be in excess of 110 decibels. A combination of software and a pulse sequence lowers the noise level to that of a chirping bird outside a window.

Historically, acoustic noise mitigation techniques have focused on insulating components and muffling sound as opposed to treating the noise at the source. With Silent Scan, acoustic noise is essentially eliminated by employing a new advanced 3-D acquisition and reconstruction technique called Silenz, in combination with GE Healthcare’s proprietary design of the high-fidelity MR gradient and RF system electronics. Silent Scan is designed to eliminate the noise at its source.

640-Slice CT Scanner

Toshiba unveiled its 640-slice Aquilion One Vision edition CT scanner. The vendor already offers the highest-slice system on the market, the 320-slice Aquilion One. The new system is equipped with a gantry rotation of 0.275 seconds, a 100 kw generator and 320 detector rows (640 unique slices) covering 16 cm in a single rotation, with the industry’s thinnest slices at 500 microns (0.5 mm). The system can accommodate larger patients with its 78 cm bore and fast rotation, including bariatric and patients with high heart rates.

FFR-Like CT Culprit Vessel Analysis

TeraRecon released new research software in response to fractional flow reserve (FFR)-CT analysis being developed by HeartFlow. The HeartFlow software uses a supercomputing algorithm to look at the fluid dynamics of the iodine contrast flow in coronary vessels to calculate a virtual a FFR number, similar to invasive pressure wire based FFR in the cath lab. TeraRecon’s Lesion Specific Analysis software cannot calculate FFR, but uses the same principle of tracking contrast flow in the myocardium. It uses lobular decomposition to look at each vessel segment to determine the tissue it feeds to show areas of ischemia and the expected culprit vessel segment. It shows a color contrast level maps on a 3-D model of the heart and in a coronal view of the left ventricle. Automated detection boxes highlight suspected ischemic areas of interest and identifies the vessel responsible for supplying blood to the region.

Radiation Dose Monitoring

Radiation dose monitoring solutions have been shown at previous RSNAs, but were highlighted by several companies this year as several states began implementing requirements for radiology departments to record patient dose. Dose records will have the most application with CT systems, especially for longer duration, higher dose cardiac exams, and catheter based angiography. Angiography is becoming an increasing issue due to the longer duration of more complex transcatheter interventions.

Toshiba demonstrated a work-in-progress dose tracking software for its Infinix-i angiography system. It can be displayed on a screen in the cath lab to show the approximate radiation dose that has been delivered cumulatively to specific areas of a patient. It takes into consideration the amount of time, power setting used and orientation of the C-arm to show a color-coded map of radiation delivery projected on a human figure. The colors change in real time as X-ray imaging continues. It is designed to be a visual reminder to physicians about the dose the patient has received and that they may want to change the location of the C-arm.

Sectra demonstrated 510(k)-pending Dose Track software, which radiology or cardiology departments can use to track radiation dose by patient, machine, physician, technologist, procedure type and room. The system can be set up to create alerts if a reasonable amount of dose if exceeded for a particular exam, or if certain physicians or technologists are using higher than average doses.

OLED Displays

Flat panel display technology migrated from CRT screens to LCDs over the past decade. The next major innovation in display technology is OLED, which offers even smaller components, faster response time than LCD, and the ability to display quick motion with virtually no blur. Sony showed the new PVM-2551MD OLED medical-grade monitor, which incorporates technology to achieve pure black, faithful to the source signal. By providing superb color reproduction, especially for dark images, surgeons can observe very subtle details such as the faint color difference between various tissues and blood vessels.

Aesthetically Pleasing Cath Labs

Philips Healthcare displayed video of its recent install of the Ambient Experience in a cath lab. The system uses colored lighting, subtle room design details and projected image visual effects to calm patients and make procedure rooms look less clinical. The installation highlighted allowed doctors or patients to choose a theme, such as a tropical rainforest, where diffused, indirect lighting would take a green hue and a photo projection on the ceiling of a tropical scene. Philips said at facilities that have installed these type of labs, patient satisfaction rose, as did staff morale. They say doctors and staff compete to use these rooms at some facilities.

Single Detector Spectral CT Imaging

Philips introduced an innovative work-in-progress CT system that uses new detector technology to simplify spectral imaging, offering soft tissue image quality similar to MRI. Currently, CT special imaging can be performed using systems with two X-ray tubes and two detectors. The new system in development uses a single X-ray source and a single detector that has two layers of detectors, one on top of the other, for high and low energy.

Better Transcatheter Mitral Valve Repair Guidance

Philips’ showed its new Echo Navigator system, designed to synchronize views from TEE ultrasound with the orientation on live angiography. The primary application is to aid navigation during transcatheter mitral valve procedures, which require very accurate 3-D echo navigation to deploy devices like the Abbott MitraClip.

3-D Sculptures From 3-D Datasets

Taking 3-D images shown on 2-D display screens to a true physical 3-D form, Vidar Systems/3D Systems displayed the new Z Printer 450. It takes any 3-D advanced visualization dataset and can print the image in true 3-D using gypsum powder (the same material used to make drywall), standard color ink jet printer cartridges and a binding agent. The image is saved as an STL file and sent to the printer, which prints 1/10th of a millimeter each pass, up to 2 cm per hour.

The 3-D sculptures it created can be printed in color, eliminating the need to paint the models.

The printer offers a new way to create 3-D anatomical models for medical education, complex surgical planning and cosmetic reconstruction. Another application suggested at RSNA was to print sculptures for sale to the patients, such as fetal faces taken from 3-D obstetrics ultrasound exams.

The company printed a full-sized, 3-D, color heart during the show using a cardiac CT dataset on a thumb drive provided by one of the advanced visualization vendors in the same hall.

  • Siemens unveiled the world’s first wireless ultrasound transducer at RSNA 2012.



1. S. Desmond-Hellmann, Toward precision medicine: A new

social contract? Sci. Transl. Med. 4, ed3 (2012).

2. J. S. Altshuler, E. Balogh, A. D. Barker, S. L. Eck, S. H. Friend,

G. S. Ginsburg, R. S. Herbst, S. J. Nass, C. M. Streeter, J. A.

Wagner, Opening up to precompetitive collaboration. Sci.

Transl. Med. 2, 52cm26 (2010).

3. U.S. commerce department study; www.ita.doc.gov/td/



4. Regulatory science in FDA’s Center for Devices and

Radiological Health: A vital framework for protecting

and promoting public healthwww.fda.gov/AboutFDA/



5. Driving Biomedical Innovation: Initiatives for Improving

Products for Patients; www.fda.gov/AboutFDA/


6. G. D. Prestwich, S. Bhatia, C. K. Breuer, S. L. Dahl, C. Mason,

R. McFarland, D. J. McQuillan, J. Sackner-Bernstein, J. Schox,

W. E. Tente, A. Trounson, What is the greatest regulatory

challenge in the translation of biomaterials to the clinic?

Sci. Transl. Med. 4, 60cm14 (2012).

7. Between Invention and Innovation. NIST GRC 02-841;


8. Justin D Pearlman, MD, ME, PhD, FACC, MA; Chief Editor: Eugene C Lin, MD

Imaging in Coronary Artery Disease, Nov 13, 2012


9. Markus Schwaiger, MD; Sibylle Ziegler, PhD; and Stephan G. Nekolla, PhD

PET/CT: Challenge for Nuclear Cardiology

THE JOURNAL OF NUCLEAR MEDICINE • Vol. 46 • No. 10 • October 2005


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