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 […]
Royal Philips
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 […]
Philips launches Ultrasound Workspace for improved echocardiography workflows
Royal Philips (NYSE:PHG) announced today that it launched the Ultrasound Workspace echocardiography image analysis and reporting platform. Amsterdam-based Philips designed the Ultrasound Workspace system for clinicians to access it remotely via browser, allowing them to leverage diagnostic workflows from the ultrasound exam room to the reporting room and beyond to wherever echocardiography data needs to […]
Philips launches Azurion image-guided therapy system with Ambient Experience with FlexVision
Royal Philips (NYSE:PHG) announced today that it made its Azurion system with Ambient Experience with FlexVision commercially available. Amsterdam-based Philips’ Ambient Experience with FlexVision display connects to the Azurion image-guided therapy system to offer patients a calming multi-sensory experience while the staff prepares them for their procedure, prior to the display then being used for […]
