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FDA Grants Breakthrough Device Status to Toku's Patented Cardiovascular Risk AI (CLAiR) Platform

Press Release Toku, Inc., a commercial medical device company specializing in imaging technology and AI, announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation to its patented CLAiR technology. The CLAiR platform, if…
New Zealand United States Ehsan Vaghefi Michaelv Mcconnell Toku Clai April Maa

New Breakthrough Devices Program Guidance: Expanding Opportunities For Medical Product Innovations - Healthcare

On September 15, 2023, FDA released a final guidance document titled "Breakthrough Devices Program." Compared to the previous version, the new guidance document highlights that the Breakthrough Devices Program ...
Health Care Breakthrough Devices Program Devices Program Disparities In Health Program Guidance Breakthrough Devices
Source: mondaq.com

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Burning Rock Received Breakthrough Device Designation from China's NMPA for its Multi-Cancer Early Detection Test

GUANGZHOU, China, Oct. 15, 2023 (GLOBE NEWSWIRE) -- Burning Rock Biotech Limited (NASDAQ: BNR and LSE: BNR, the “Company” or “Burning Rock”) is pleased to announce that followed an earlier Breakthrough Device Designation granted by the US Food and Drug Administration (FDA) for its OverC™ Multi-Cancer Detection Blood Test (MCDBT) in January 2023, its OverC™ MCDBT has been granted Breakthrough Device Designation by the China National Medical Products Admin...
Yusheng Han Burning Rock Biotech Limited Company Or Burning Rock China National Medical Products Administration Drug Administration Rock Biotech Limited
Source: yahoo.com

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