FDA announces class 1 recalls for heart devices, ventilators
Editor's Note The US Food and Drug Administration (FDA) has classified recalls of Abbot’s HeartMate 3 Left Ventricular Assist System (LVAS) implant kits and Phillips Respironics' Trilogy Evo ventilators as class 1, the most serious category indicating risk of serious injury or death. Used while waiting for recovery, a transplant,…
FDA warns of continued cardiac pump safety concerns after series of recalls
Editor's Note The US Food and Drug Administration (FDA) is urging healthcare providers to avoid using Getinge heart devices due to continued safety concerns that remain unaddressed despite previous recalls. Issued to healthcare providers May 8, the warning letter applies to Getinge/Maquet/Datascope Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pump (IABP) devices…
Gene-edited pig kidney, heart pump combined in transplant surgery milestone
Editor's Note The second-ever living recipient of a gene-edited pig kidney was the first to have the new organ paired with a mechanical heart pump, according to an April 24 CNN report. The subject, 54-year-old Lisa Pisano, underwent the milestone surgery at NYU Langone Health. She had heart failure and…
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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