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 […]
Royal Philips
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 […]
Government warns on cybersecurity issues with Philips’ e-Alert MRI monitoring system
The U.S. Cyber Security & Infrastructure Security Agency (CISA) today issued a notice regarding the e-Alert system from Royal Philips (NYSE:PHG). CISA called attention to the e-Alert MRI system monitoring platform (version 2.7 and prior) and a potential vulnerability related to “missing authentication for critical function.” According to the CISA notice, successful exploitation of the […]
Philips warns on software defect in some Azurion systems
Royal Philips (NYSE:PHG) has issued an urgent field safety notice about a software defect in its Azurion system. The notice, issued last month in Europe, informed users of a problem that can occur when the user selects the “Add Study” function to add a new study to a patient when using the Azurion image-guided therapy […]
FDA clears Philips Capsule Surveillance for remote patient monitoring
Royal Philips (NYSE:PHG) announced today that it received FDA 510(k) clearance for its latest Philips Capsule Surveillance system. Amsterdam-based Philips designed its Philips Capsule Surveillance solution to aggregate patient data, analyze the data to generate actionable insights and alerts and send timely notifications to caregivers so they can intervene before any patient deterioration progresses further. […]
Philips introduces new cloud-enabled enterprise imaging informatics and analytics products
Royal Philips (NYSE:PHG, AEX:PHIA) today unveiled new analytics and interoperability offerings at the 2022 HIMSS Global Health Conference and Exhibition. The two products — Philips HealthSuite Interoperability and Philips Enterprise Performance Analytics Performance Bridge — are pending 510(k) clearance by the FDA, the company said. The first, Philips HealthSuite Interoperability, is what Philips in a […]
Philips is betting big on the cloud; two leaders discuss the connected future
Royal Philips (NYSE:PHG, AEX:PHIA) bet big on the cloud in 2021, buying Capsule Technologies for $635 million to integrate Capsule’s medical device integration and data technologies with Philips’ cloud-based digital health platform. The Philips Capsule Medical Device Information Platform (MDIP) can now integrate with more than 1,000 unique types of medical devices, the Dutch medtech […]
Royal Philips patient monitors win FDA clearance
Royal Philips today said its patient monitors MX750 and MX850 have received FDA 510(k) clearance. The Amsterdam-based company’s patient monitors first received emergency use authorization during the pandemic in 2020. The company designed them to support scalability, alarm management, cybersecurity and enhanced infection prevention in the hospital. Philips’ patient monitors are an integrated part of […]
The 10 largest medtech employers of 2021 – and what their employees really think
Employees of the 10 largest medtech employers are proud of working on life-saving products — with a greater appreciation for diversity and inclusion initiatives. That was one major takeaway as Medical Design & Outsourcing compiled some current and former employee reviews posted on Glassdoor. (Browse the online version of our Big 100 report.) Despite the pride, there was […]
FDA says Philips knew about toxic foam for years before massive recall
The FDA said it observed potential violations of federal medical device safety rules when inspecting a Philips Respironics manufacturing facility connected to the Class I recall of more than 15 million respiratory devices. The FDA recently requested additional safety testing on replacement materials and issued a Form 483. The form details how Philips and its foam supplier were aware […]