Feeds:
Posts
Comments

Archive for the ‘Global Market of Medical Devices Technology’ Category

New resource for finding FDA-approved medical devices that incorporate AI

Reporter: Satwik Sunnam, Research Assistant 3, One year Internship in Medical Text Analysis with Deep Learning NLP

This article reports List of FDA approved medical devices that are employing Artificial Intelligence and Machine Learning (AI/ML)

The FDA is providing this initial list of AI/ML-enabled medical devices marketed in the United States as a resource to the public about these devices and the FDA’s work in this area.

Contents of this list: This initial list contains publicly available information on AI/ML-enabled devices. The FDA assembled this list by searching FDA’s publicly-facing information, as well as by reviewing information in the publicly available resources cited below (*) and in other publicly available materials published by the specific manufacturers.

This list is not meant to be an exhaustive or comprehensive resource of AI/ML-enabled medical devices. Rather, it is a list of AI/ML-enabled devices across medical disciplines, based on publicly available information.

Updates to this list: The FDA plans to update this list on a periodic basis based on publicly available information. Send questions or feedback on this list to digitalhealth@fda.hhs.gov.

AI/ML-Enabled Medical Devices

Devices are listed in reverse chronological order by Date of Final Decision. To change the sort order, click the arrows in the column headings.

Use the Submission Number link to display the approval, authorization, or clearance information for the device in the appropriate FDA database. The database page will include a link to the FDA’s publicly available information.

Devices are listed in reverse chronological order by Date of Final Decision. To change the sort order, click the arrows in the column headings.

Use the Submission Number link to display the approval, authorization, or clearance information for the device in the appropriate FDA database. The database page will include a link to the FDA’s publicly available information.

FDA Final Decision in 2021:

List of AI/ML-enabled medical devices marketed in the United States

Date of Final Decision Submission NumberDeviceCompanyPanel (Lead)
06/17/2021K203514Precise PositionPhilips Healthcare (Suzhou) Co., Ltd.Radiology
06/16/2021K202718Qmenta Care Platform FamilyMint Labs, Inc., D/B/A. QMENTARadiology
06/11/2021K210484LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification SystemMedtronic, Inc.Cardiovascular
06/10/2021K203629IDx-DRDigital Diagnostics Inc.Ophthalmic
06/02/2021DEN200069Cognoa Asd Diagnosis AidCognoa, Inc.Neurology
05/19/2021K210237CINA CHESTAvicenna.AIRadiology
04/30/2021K210001HYPER AiRShanghai United Imaging Healthcare Co.,Ltd.Radiology
04/23/2021K203314Cartesion Prime (PCD-1000A/3) V10.8Canon Medical Systems CorporationRadiology
04/23/2021K203502MEDO-ThyroidMEDO DX Pte. Ltd.Radiology
04/21/2021K210556Preview ShoulderGenesis Software InnovationsRadiology
04/20/2021K203610Automatic Anatomy Recognition (AAR)Quantitative Radiology Solutions, LLCRadiology
04/19/2021K203469AI SegmentationVarian Medical SystemsRadiology
04/16/2021K203517Saige-QDeepHealth, Inc.Radiology
04/14/2021K202992BriefCase, RIB Fractures Triage (RibFx)Aidoc Medical, Ltd.Radiology
04/09/2021DEN200055GI GeniusCosmo Artificial Intelligence – AI, Ltd.Gastroenterology-Urology
04/02/2021K202441Eclipse II with Smart Noise CancellationCarestream Health, Inc.Radiology
04/01/2021DEN200038Gili Pro Biosensor (Also Known as Gili Biosensor System)Continuse Biometrics Ltd.Cardiovascular
03/31/2021K203258syngo.CT Lung CAD (Version VD20)Siemens Healthcare GmbHRadiology
03/31/2021K203443MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM Altea with syngo MR XA31ASiemens Medical Solutions USA, Inc.Radiology
03/31/2021K210071SIS System (Version 5.1.0)Surgical Information Sciences, Inc.Radiology
03/26/2021DEN200019Oxehealth Vital SignsOxehealth LimitedCardiovascular
03/24/2021K203225Aquilion ONE (TSX‐306A/3) V10.4 with Spectral Imaging SystemCanon Medical Systems CorporationRadiology
03/23/2021K210209Viz ICHViz.Ai, Inc.Radiology
03/19/2021K203235VBrainVysioneer Inc.Radiology
03/09/2021K203256Imbio RV/LV SoftwareImbio, LLCRadiology
03/05/2021K202300Optellum Virtual Nodule Clinic, Optellum Software, Optellum PlatformOptellum LtdRadiology
03/01/2021DEN200022Analytic for Hemodynamic Instability (AHI)Fifth Eye Inc.Cardiovascular
02/25/2021K202990NinesMeasureNines, Inc.Radiology
02/25/2021K203578OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography SystemPerimeter Medical Imaging AI, Inc.General And Plastic Surgery
02/19/2021K202212TruplanCircle Cardiovascular Imaging Inc.Radiology
02/09/2021K203103Synapse 3D, Synapse 3D Base Tools v6.1Fujifilm CorporationRadiology
02/05/2021K210053LVivo Software ApplicationDiA Imaging Analysis Ltd.Radiology
01/29/2021K201411Visage Breast DensityVisage Imaging GmbHRadiology
01/15/2021K193271UAI Easytriage-RibShanghai United Imaging Intelligence Co., Ltd.Radiology
01/14/2021K202700ART-PlanTheraPanaceaRadiology
01/12/2021K201836Aquilion Lightning (TSX-036A/7) V10.2 With AiCE-ICanon Medical Systems CorporationRadiology
01/09/2021K200717CLEWICU System (ClewICUserver and ClewICUnitor)Clew Medical Ltd.Cardiovascular
01/07/2021K202414BrainInsightHyperfine Research, Inc.Radiology

SOURCE

https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-aiml-enabled-medical-devices?utm_medium=email

Other related articles Published in this Open Access Online Scientific Journal include the following:

Cardiac MRI Imaging Breakthrough: The First AI-assisted Cardiac MRI Scan Solution, HeartVista Receives FDA 510(k) Clearance for One Click™ Cardiac MRI Package

Reporter: Aviva Lev-Ari, PhD, RN

Al is on the way to lead critical ED decisions on CT

Curator and Reporter: Dr. Premalata Pati, Ph.D., Postdoc

Applying AI to Improve Interpretation of Medical Imaging

Author and Curator: Dror Nir, PhD

Developing Deep Learning Models (DL) for the Instant Prediction of Patients with Epilepsy

Reporter: Srinivas Sriram, Research Assistant I

Science Policy Forum: Should we trust healthcare explanations from AI predictive systems – Some in industry voice their concerns

Curator: Stephen J. Williams, PhD

Al System Used to Detect Lung Cancer

Reporter: Irina Robu, Ph.D.

The Future of Speech-Based Human-Computer Interaction
Reporter: Ethan Coomber

Deep Medicine: How Artificial Intelligence Can Make Health Care Human Again
Reporter: Aviva Lev-Ari, PhD, RN

Supporting the elderly: A caring robot with ‘emotions’ and memory
Reporter: Aviva Lev-Ari, PhD, RN

Developing Deep Learning Models (DL) for Classifying Emotions through Brainwaves
Reporter: Abhisar Anand, Research Assistant I

Read Full Post »

Mapping Medical Device Startups Across The Globe per Funding Criteria

Reporter: Aviva Lev-Ari, PhD, RN

 

The Funding Criteria is explain in the Image Source.

 

Med-Tech Planet: Mapping Medical Device Startups Across The Globe

IMAGE SOURCE

https://www.cbinsights.com/blog/medical-device-most-well-funded-startups-global-map/?utm_source=CB+Insights+Newsletter&utm_campaign=63eed75a5f-WedNL_5_3_2017&utm_medium=email&utm_term=0_9dc0513989-63eed75a5f-87377285

Most Well-Funded Medical Device Companies Across the Globe

IMAGE SOURCE

https://www.cbinsights.com/blog/medical-device-most-well-funded-startups-global-map/?utm_source=CB+Insights+Newsletter&utm_campaign=63eed75a5f-WedNL_5_3_2017&utm_medium=email&utm_term=0_9dc0513989-63eed75a5f-87377285

Other related articles published in this Open Access Online Scientific Journal include the following:

Search Results for ‘Medical Devices’ – 221 Articles

https://pharmaceuticalintelligence.com/?s=Medical+Devices

Read Full Post »