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 […]
Philips
Philips receives FDA warning letter over imaging systems manufactured in China
The FDA published a warning letter that it sent to Philips that outlines issues around imaging technology manufacturing practices. During an inspection of a manufacturing facility in Suzhou, China, the FDA determined that the devices are “adultered.” The inspection took place from Oct. 23, 2023, through Oct. 26, 2023. Philips received the letter outlining violations […]
FDA clears new Zenition 30 mobile C-arm from Philips
Philips announced today that the FDA granted 510(k) clearance for its Zenition 30 mobile C-arm. Zenition 30 reduces the dependency on support personnel by giving surgeons greater flexibility, control and personalization of C-arm movement and user settings. This can help to alleviate staff shortages that limit patient access and increase waiting times. It could also […]
TSSC seeks funding to get fiber optic sensor tech across the finish line
The Shape Sensing Co. is seeking investors to fund the productization and FDA clearance of its fiber optic sensor technology for surgical navigation. Austin, Texas-based TSSC wants to raise $10 million in the Series B round, CEO Ryan DeBoer said in an interview with MassDevice. That should be enough for two-and-a-half years of runway, enough […]
Philips comes to consent decree agreement with DOJ, FDA over Respironics recall
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, AWS expand partnership on digital pathology in the cloud
Philips today announced an expanded partnership with Amazon Web Services (AWS) based around digital pathology in the cloud. The two initially linked up about a year ago, inking a deal to develop generative AI applications. This partnership centered around Philips’ imaging archiving and communications system. It wasn’t the first time a medtech giant linked up […]
Philips, SyntheticMR partner on AI-based brain imaging
Philips announced today that it launched its Smart Quant Neuro 3D for brain disorder diagnosis and therapy. The company unveiled the system at ECR2024 in partnership with Swedish MRI software solutions company SyntheticMR. Smart Quant Neuro 3D provides objective decision support for disorders like multiple sclerosis (MS), traumatic brain injury (TBI), and dementia. According to […]
Philips unveils new AI-enabled CT imaging tech
Philips announced today that it launched its CT 5300 system, a flexible X-ray CT platform with advanced AI capabilities. Amsterdam-based Philips says the system increases diagnostic confidence, streamlines workflow efficiency and maximizes system up-time. It helps to improve overall patient outcomes and department productivity. Philips unveiled the new system at ECR2024. CT 5300 meets advanced […]
Philips taps Stryker controller as next CFO
Philips announced today that it proposes to appoint Charlotte Hanneman as a member of its management board as chief financial officer (CFO). The Dutch medtech giant proposed to make the appointment effective on Oct. 1, 2024. It must submit its proposal to the annual general meeting of shareholders scheduled for May 7, 2024. Philips expects […]
Philips launches new Azurion neuro biplane system for neurovascular interventions
Philips announced today that it made major enhancements to its Azurion image-guided therapy system with a new launch. The Amsterdam-based medtech giant unveiled its new Azurion neuro biplane system at ECR 2024. It designed the system to streamline neurovascular procedures and help care teams make the right decisions and do so faster. This enables the […]
Philips unveils radiation-free imaging tech that uses light instead of X-ray
Philips announced the introduction of its new LumiGuide imaging technology that uses light to help navigate blood vessels. The company has now made LumiGuide — first used in late 2023 to treat patients in the Netherlands — available to major aortic centers that perform complex aortic repairs in the U.S. and Europe. LumiGuide offers radiation-free […]