Calling the situation “untenable” and “unacceptable,” powerful US Sen. Richard Blumenthal has given Vitor Rocha two weeks to answer questions about Philips’ high-risk recall of certain BiPAP, CPAP, and other mechanical ventilator devices.
Calling the situation “untenable” and “unacceptable,” a powerful US senator has given the CEO of Philips North America a deadline to hand over information about a recent high-risk class I recall of the company’s sleep and ventilator devices.
Royal Philips initiated the recall on 14 June because sound abatement foam used in certain bi-level positive airway pressure (BiPAP),...
Two recent recalls from the US FDA involve three deaths linked to an issue with an Abiomed heart pump — as well as three serious injuries related to angiographic catheters from Cook Medical.
The US FDA has issued an early alert to notify consumers about serious risks associated with a recall from Medtronic and its subsidiary Given Imaging. The alert concerns delivery capsules for diagnosing GERD.
After two serious injuries and one death linked to some of its ventilators, Medtronic has recalled the devices and asked customers to stop using them and find alternative means. The action comes more than a year after the company left the market.
The US FDA’s device center sent warning letters to three domestic device manufacturers and one German firm for failing to adhere to protocol on several issues.
Broad participation by EU member states in a new pilot to test a unified procedure for evaluating applications for combined drug and IVD studies shows they recognize its value, says Monique Al, vice-chair of the Clinical Trials Coordination Group.
MedTech Europe is ready to become involved and shape Europe’s Life Sciences Strategy and help drive regulatory simplification from the top to make the EU “the world’s most attractive place for life sciences by 2030.”
The UK government’s blueprint to deliver an NHS "fit for the future" was released on July 3.
