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With medical devices, recalls are not always what they seem. In some recalls, including some of the most serious, the FDA and the manufacturers let doctors and hospitals continue to use the devices.
Consumers Union recommends that the FDA: Require that implants and other "life-sustaining" devices be tested ... connect them to the heart. There have been two major recalls, in 2007 and ...
The FDA elevated a recall of intraocular lenses currently ... announced it would begin pulling certain models of its enVista implants in late March and early April, including its Aspire and ...
Abbott Laboratories has announced that its implantable heart device, MitraClip, has not been recommended for approval by reviewers at the US Food and Drug Administration. Clinical trials ...
The FDA has approved expanded labelling for Abbott's CardioMEMS HF System, an implantable sensor that provides an early warning of worsening heart failure, that could make it an option for more ...
VVeno Medical (Nasdaq:NVNO) announced three-year outcomes for its heart valve that it aims to submit to the FDA this year.
Carmat is preparing to commence implants ... tumour. "FDA conditionally approves second cohort of Carmat’s artificial heart study" was originally created and published by Medical Device Network ...
Omniasecure, which was authorized for placement in the heart’s right ventricle, is the world’s smallest defibrillation lead, ...
The SOLVE-CRT trial has delivered promising results for heart ... devices—pacemakers, ICDs, or CRTs—using a subcutaneous ultrasound Transmitter to power an ultra-compact Electrode implanted ...
Health Check: With the FDA’s approval, EBR is ready to revolutionise the heart failure device market
The US Food & Drug Administration has approved EBR System’s leadless pacemaker WISE, the only device able to deliver left-ventricle stimulation. Don't miss out on the headlines from Stockhead.
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