The Food and Drug Administration issued draft guidance Jan. 6 on marketing submissions and lifecycle management for ...
Artificial intelligence (AI) is transforming the health care landscape, from diagnostics to drug development and clinical trials. As AI ...
The Nanoleaf LED Light Therapy Face Mask is made of medical-grade materials and has received FDA Class II device ...
The Food and Drug Administration on Monday proposed a long-awaited plan aimed at improving how pulse oximeters work on people ...
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Years of research have showed that pulse oximeters yield less accurate readings for people with darker skin tones, and now ...
A Food and Drug Administration (FDA) draft guidance would require manufacturers of pulse oximeters to gather far more ...
Shares of IBD 50's GeneDx surged Monday after the Food and Drug Administration issued guidance about using AI to develop medical devices.
The agency issued the alert as part of a pilot to improve the timeliness of communications about actions it believes are ...
Multibillion-dollar buyouts returned last year, led by Johnson & Johnson’s $13.1 billion acquisition of Shockwave Medical. Edwards submitted a request for a national coverage determination in February ...
Costco eggs recalled were given a recall of the highest level by the Food and Drug Administration for potential contamination with salmonella.
The medical device sector faces significant changes, as both Donald Trump and Robert F. Kennedy Jr. have identified the FDA ...
While generative artificial intelligence ("GenAI") has the potential to fundamentally change health care, it presents unique risks and ...
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