FDA Class 1 recall renews concern about historically problematic heart pumps
The US Food & Drug Administration (FDA) announced a Class 1 recall on Monday for Abbott/Thoratec Corp.’s HeartMate II and HeartMate 3 Left Ventricular Assist System (LVAS) due due to biological material buildup obstructing the devices. According to an April 16 CBS News report, surgeons first noticed problems with the…
Transcatheter therapy system becomes first to earn FDA approval for treating tricuspid regurgitation
Editor's Note Patients with severe cases of tricuspid regurgitation (in which a critical heart valve fails to close properly) now have a new treatment option thanks to the recent US Food and Drug Administration (FDA) approval of the ENVOQUE tricuspid valve replacement system, according to a February 2 press release…
Discrepancies in FDA clearance, marketing of AI-, ML-enabled medical devices
Editor's Note This study from New York University and NYU Langone Health, New York City, finds discrepancies between the marketing and 510(k) clearance of artificial intelligence (AI)- or machine learning (ML)-enabled medical devices, with some devices being marketed as having capabilities not approved by the Food and Drug Administration (FDA).…
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