Royal Philips (NYSE:PHG) says only a small portion of returned respiratory devices displayed the sound abatement foam degradation that sparked a massive recall. Repeated ozone cleaning may have made the problem worse. Those were some of the major takeaways from an update Philips provided today on a comprehensive test and research program it implemented after […]
Royal Philips
Philips names Willem Appelo as chief operations officer
Royal Philips (NYSE:PHG) today announced that it has named Willem Appelo as chief operations officer, effective October 1. Appelo is slated to join the Amsterdam-based company’s executive committee on July 18. He will succeed Sophie Bechu as chief operations officer, who will continue to work on project-based initiatives until her retirement in January 2023. Appelo […]
FDA says Philips ventilator recall produced over 21,000 device reports, 124 deaths
The FDA updated its communications on Philips‘ (NYSE:PHG) major ventilator recall with new data on device reports and patient deaths. In June 2021, Philips Respironics recalled millions of certain ventilators, bi-level positive airway pressure (BiPAP) and continuous positive airway pressure (CPAP) machines due to potential health risks caused by polyester-based polyurethane (PE-PUR) sound abatement foam […]
FDA clears Philips’ MR 7700 imaging system
Philips (NYSE:PHG) announced today that it received FDA 510(k) clearance for its new MR 7700 3.0T MR imaging system. Amsterdam-based Philips said it designed the MR 7700 system to provide high accuracy to support clinical diagnostics through high-quality diffusion imaging and advanced neuroscience. The company said in a news release that MR 7700 expands scanning […]
Fresenius Medical Care hires replacement for longtime CEO
Fresenius Medical Care (NYSE: FMS) has hired Carla Kriwet as its next CEO, effective Jan. 1, 2023. Kriwet will replace Rice Powell, who will step down on Dec. 31 after hitting the company’s age limit. Powell is 66. Kriwet is 51. “I fully identify with the vision of making the lives of the patients who […]
Medtech CEOs sound off on semiconductor shortage, pushing Biden administration for prioritization
AdvaMed continues to push the Biden administration to prioritize medical device manufacturers for semiconductor supplies. With medtech companies still struggling to source chips amid a global shortage, the industry association held a meeting this week with some of its members and Secretary of Commerce Gina Raimondo to make their case. “Semiconductor chips are crucial to […]
FDA may order Philips to resolve respiratory devices recall
The FDA has proposed an order requiring Philips (NYSE:PHG) to submit a plan for its recalled respiratory devices. FDA’s proposal regards the June 2021 recall of millions of certain Philips ventilators, bi-level positive airway pressure (BiPAP) and continuous positive airway pressure (CPAP) machines due to potential health risks caused by polyester-based polyurethane (PE-PUR) sound abatement […]
DOJ subpoenas Philips over Respironics recall; CEO addresses investigation
Royal Philips (NYSE:PHG) today disclosed a Department of Justice subpoena for information related to the massive recall of Respironics respiratory devices. Philips Respironics and Philips subsidiaries in the U.S. received the subpoena on April 8 seeking “information related to events leading to the Respironics recall,” the Amsterdam-based company said as it announced its latest financial […]
Philips shares take a dive as supply chain issues, ventilator recalls impact Q1 results
Royal Philips (NYSE:PHG) shares took a hit today on first-quarter results that felt the effects of ongoing issues with supply chain and recalls. PHG shares were down 12.1% at $26.67 in midday trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — was virtually even on the […]
Philips says CavaClear used successfully for IVC filter removal
Royal Philips (NYSE:PHG) announced today that the first patients were successfully treated with its CavaClear IVC filter removal laser sheath. Patients were treated for inferior vena cava (IVC) filter removal using CavaClear at Northwestern Medicine (Chicago) by Dr. Kush R. Desai and at Stanford Hospital (Palo Alto, California) by Dr. William T. Kuo. Amsterdam-based Philips […]
Philips has another round of serious ventilator recalls
Royal Philips’ (NYSE:PHG) ventilator problems continue as the company has issued further recalls for its respiratory devices. FDA earlier this week said it was designating more Philips recalls as Class I — the most serious kind. The recalls involve all models of the Philips Respironics V60 ventilator, the V60 Plus ventilator and the V680 ventilator […]