The agency OK’d an artificial vessel to restore blood flow in patients, even though its own scientists flagged questionable ...

The U.S. Food and Drug Administration (FDA) has issued a series of important updates addressing healthcare challenges, ...

The U.S. Food and Drug Administration (FDA) has announced a series of critical updates this week, reflecting its ongoing ...

This recognition underscores the FDA’s acknowledgment of Powerful Medical's STEMI AI ECG Model, dubbed “Queen of Hearts”, to ...

XBeta founder Frederick Kruger offers advice for medical device startups based on his firm's development of the Spiro Wave ...

Abbott Laboratories (NYSE:ABT) has caught investor attention with the FDA’s approval of an Investigational Device Exemption (IDE) for its Coronary Intravascular Lithotripsy (IVL) System, a significant ...

Parkinson's disease patients and advocates are marking Friday as the start of a new era for treatment of the illness as a ...

Mehmet Oz, President Trump’s pick to lead the CMS, said Medicare beneficiaries should have quicker access to new medical ...

Sooma announced that it received FDA investigational device exemption (IDE) for its transcranial direct current stimulation ...

Achieves Significant Milestone with Expanded Use Indication, Opens Sizable New SI Market Opportunity ~ LOS GATOS, CA / ACCESS ...

The approval expands the indication for Amvuttra, which now becomes the first and only therapeutic approved by the FDA for ...

The US Food and Drug Administration has approved Nanosonics' next-generation medical probe sterilising device, dubbed Coris.