Philips today announced a final agreement on a consent decree with the FDA and U.S. Dept. of Justice (DOJ). The consent decree primarily focuses on its Philips’ Pennsylvania-based Respironics business — the subject of a major recall over the past several years. That includes manufacturing facilities in Murrysville and New Kensington, a service center in […]
Philips Respironics
Philips discontinues certain CPAP product lines after recall saga, stock sinks on Q4 results
Philips has discontinued the U.S. sales of several respiratory device product lines, including one from its much-maligned CPAP portfolio. The company says it agreed with the FDA and the DOJ on the terms of a consent decree focused on the Respironics business. Philips says it provides “clarity and a roadmap” for compliance and the restoration […]
How Philips’ significant respiratory devices recall unfolded
There are 5.5 million recalled CPAPs and other devices — and reports of deaths. Here’s a Philips recall timeline. Philips in mid-2021 kicked off a recall that involved millions of CPAP and BiPAP ventilators and other respiratory devices. The devices — used for sleep apnea therapy and more — had sound abatement foam that could […]
Report: Concerning chemicals found in replacement Philips CPAPs
Replacement machines issued by Philips amid its respiratory device recall may have more issues, according to ProPublica and the Pittsburgh Post-Gazette. Philips Respironics has recalled more than 5 million devices since 2021 due to dangerous degradation of sound abatement foam. The FDA has received more than 100,000 reports of problems related to the recall, including at […]
The top medtech trends of 2023
The top medtech trends of 2023 included innovations such as artificial intelligence, new GLP-1 weight loss drugs and some long-awaited medtech finally receiving regulatory nods. With health providers facing additional challenges on top of an ever-uncertain economic environment, medtech companies also made major readjustments: layoffs, spinoffs, reorganizations and much more. Here are the top stories […]
U.S. senators call for review of FDA following Philips recall fallout
Two U.S. senators sent a letter calling on the government to review the FDA’s oversight of medical device recalls amid the ongoing Philips Respironics recall. Majority Whip Dick Durbin (D-IL) and Sen. Richard Blumenthal (D-CT) sent the letter to the Government Accountability Office (GAO). The letter requests an update to a 2011 GAO report entitled […]
Philips CEO Roy Jakobs reportedly approved continued sale of defective sleep respiratory devices
A new report from ProPublica and the Pittsburgh Post-Gazette claims to shed more light on the alleged role of Philips CEO Roy Jakobs in the ongoing Respironics recall. Philips has been handling a Class I recall of certain respiratory devices since mid-2021. Respironics recalled millions of ventilators, bi-level positive airway pressure (BiPAP) and continuous positive airway pressure (CPAP) machines. […]
Philips stock rises on Q3 growth, increased 2023 outlook
Philips (NYSE:PHG) shares ticked up today on third-quarter results that came in ahead of the consensus forecast on Wall Street. Shares of PHG rose 2.8% at $18.77 apiece in late-morning trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — fell 0.14%. The Amsterdam-based company posted profits […]
FDA wants more testing in Philips recall
The FDA has issued a communication stating its desire for more testing in the massive respiratory device recall at Philips . The morning after the FDA’s evening announcement, PHG shares were down more than 7% on the NYSE to $18.31 apiece. PHIA shares in Amsterdam closed the day down more than 8%. (MassDevice’s MedTech 100 […]
The Philips CPAP recall settlement could be just be the start
Philips is set to pay at least $479 million to settle claims related to its ongoing Respironics recall. It could just be the beginning of settling what has arguably been one of the medical device industry’s most serious recalls in recent decades. (Here is a full timeline of the Philips recall.) Subject to approval in […]
Philips reaches settlement in class-action lawsuit over sleep apnea machine recall
Philips announced today that it reached a class-action settlement on economic loss claims related to its ongoing Respironics recall. The agreement resolves all economic loss claims in the U.S. multidistrict litigation (MDL) related to the voluntary recall. Philips expects to submit the settlement to the U.S. District Court for the Western District of Pennsylvania later […]