Medtech developers incorporating AI or machine learning into medical devices need to recognize if and how FDA will regulate ...

Light AI Inc. ("Light AI" or the "Company") (CBOE CA: ALGO) (FSE: OHC) (OTCQB: OHCFF), a digital healthcare technology company focused on developing artificial intelligence ("AI") health diagnostic ...

Software-based medical devices are integral to healthcare. To enter the marketplace, a company must successfully navigate and comply with applicable national and international regulatory requirements.

Opinion: In response to the FDA's updated cybersecurity guidance on medical devices, manufacturers should follow "secure by design" principles, ensure cyber transparency, conduct threat modeling, and ...

The Food and Drug Administration (FDA) has released guidance providing recommendations on what information should be included in a predetermined change control plan (PCCP) tailored to marketing ...

The US Food and Drug Administration has updated its draft guidance on how the drug and medical device makers should communicate with payors and other stakeholders about their products. The updates are ...

The US Food and Drug Administration (FDA) has chosen to axe its ‘Final Rule’ from May 2024, bringing to an end a long-running agency-industry dispute around the proposed classification of ...

Since the late 1980s, FDA has been publicly declaring that there exists a category of software that technically qualifies as a medical device but for which FDA has no intention of requiring the ...

The tool aims to reduce planning time and help care teams create more tailored strategies.

“Don’t fear the Reaper,” the rock band Blue Öyster Cult famously advised. For many digital health companies, the Food and Drug Administration’s recently revised guidances affecting the classification ...