Senator To Philips CEO: Fork Over Info On Class I Recall Of Sleep, Ventilator Devices – Pronto
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.
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Legislation introduced in both houses of Congress would improve how the FDA handles medical device recalls by requiring the agency to establish an electronic format to streamline communication among stakeholders.
News We're Watching: FDA Announces Meetings On Ortho Safety And Radiology; News Orgs Sue FDA For Philips Docs, ITC Delays Apple Watch Case; And More
This week, FDA announced plans for cybersecurity and meetings to discuss orthopedic device safety and radiological devices. ProPublica and the Pittsburgh Post-Gazette insist that the FDA to divulge more information about the ongoing Philips recalls. SetPoint is trying to treat Crohn's disease with its vagus nerve stimulator. ITC delayed the Apple Watch patent case again.
Vindication, Or Spin? Philips Says Tests Confirm Safety Of Breathing Machines. Plaintiff Attorneys Argue Results Lack Credibility
Royal Philips says independent tests show its sleep therapy devices, which have been the subject of controversy since being recalled in June 2021, are safe and unlikely to harm patients. Attorneys representing patients suing the company call the results a shameless attempt to deflect blame.