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Philips warns on software defect in some Azurion systems

Royal Philips (NYSE:PHG) issued an urgent field safety notice to warn on a software defect with 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 platform.

In the software, the Add Study dialogue box is displayed where the patient type is selected to perform the study, but, due to a software defect, when the study is initiated by selecting “Start Procedure,” the patient type inadvertently changes to one different than the one selected.

A change in patient type could lead to image quality degradation (which would see the radiation dose at a level considered too low) or an additional X-ray dose for the patient (leading to higher radiation than required). No harm is expected from the additional radiation dose, according to the notice.

Philips has receiv…

FDA clears Philips Capsule Surveillance for remote patient monitoring

[Image from Philips]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.

The company said in a news release that the latest release includes expanded interoperability into hospitals’ existing mobile clinical communication and collaboration tools, as well as electronic intensive care units and virtual care population health management systems. Philips said this design offers more visibility on live streaming data, waveforms, device alarms and contextual alerts.

Philips Capsule Surveillance allows clinicians to see patient data and patient monitor settings and alarms from multiple device types without…

Philips introduces new cloud-enabled enterprise imaging informatics and analytics products

Philips Data Management and Interoperability Solutions [Photo courtesy of Philips]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 news release called “a fully integrated cloud-enabled Health IT platform to meet diverse workflow needs across the imaging enterprise,” while Performance Bridge “provides operational insights and deep analytics beyond radiology to the cardiology department to enhance efficiencies and help improve effectiveness at the point of care,” according to a news release.

Get the full story at our sister site, Medical Design & Outsourcing.

Philips is betting big on the cloud; two leaders discuss the connected future

Christine Storm, Virtual Care Solutions business category leader at Philips [Photo courtesy of Philips]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 giant said in October.

To help understand what’s possible in medtech with the cloud, Medical Design & Outsourcing asked two leaders at Philips — Virtual Care Solutions Business Category Leader Christine Storm and Informatics Transformational Programs Leader Bas Kuppens — to offer their perspectives.

Get the full story at our sister site, Medical Design & Outsourcing.

Philips is betting big on the cloud; two leaders discuss the connected future

Christine Storm, Virtual Care Solutions business category leader at Philips [Photo courtesy of Philips]

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 giant said in October.

To help understand what’s possible in medtech with the cloud, Medical Design & Outsourcing asked two leaders at Philips — Virtual Care Solutions Business Category Leader Christine Storm and Informatics Transformational Programs Leader Bas Kuppens — to offer their perspectives. The following exchange has been edited for space and clarity.

MDO: What are some surprising and…

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 company’s acute patient management system and allow hospitals to standardize at a system level to customize the care for individual patients through a virtual or decentralized method. The monitors have full modularity and are interoperable with other devices and applications, including Philips’ Patient Information Center iX and IntelliVue XDS software.

“Continuous patient monitoring plays a vital role in overall patient safety while providing clinicians and caregivers with the holistic view they need to best support their patients a…

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 also some frustration with big corporate bureaucracy.

Medtech employment in MDO‘s 2021 Big 100 was down slightly from our 2020 and 2019 reports — even as the industry continued to be on the frontlines of the COVID-19 pandemic. It’s worth noting that of the nearly 90 companies in this year’s Big 100 that provided employment data, about half added workers amid the pandemic. Another handful kept their headcounts the same.

The companies are the largest medical device industry employers in our most recent annual Big 100 list, which includes the top 100 medtech companies across the w…

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 also some frustration with big corporate bureaucracy.

Medtech employment in MDO‘s 2021 Big 100 was down slightly from our 2020 and 2019 reports — even as the industry continued to be on the frontlines of the COVID-19 pandemic. It’s worth noting that of the nearly 90 companies in this year’s Big 100 that provided employment data, about half added workers amid the pandemic. Another handful kept their headcounts the same.

The companies are the largest medical device industry employers in our most recent annual Big 100 list, which includes the top 100 medtech comp…

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 for years that polyester-based polyurethane (PE-PUR) sound abatement foam could break down and potentially enter a device’s air pathway, causing health problems for users.

In the Form 483, FDA alerted management at the Royal Philips (NYSE:PHG) subsidiary of conditions that the inspector considered possible violations of the U.S. Food, Drug and Cosmetic Act or related regulations. The post-inspection report is not a determination of wrongdoing and will be considered by the FDA along with any evidence or documents collected from the facility and responses offered by Philips.

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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 for years that polyester-based polyurethane (PE-PUR) sound abatement foam could break down and potentially enter a device’s air pathway, causing health problems for users.

In the Form 483, FDA alerted management at the Royal Philips (NYSE:PHG) subsidiary of conditions that the inspector considered possible violations of the U.S. Food, Drug and Cosmetic Act or related regulations. The post-inspection report is not a determination of wrongdoing and will be considered by the FDA along with any evidence or documents collected from the facility and responses offered by Philips. (Le…

FDA requests safety testing of replacement foam in Philips sleep devices recall

The FDA said it has requested additional safety testing on the material used to repair Royal Philips (NYSE:PHG) sleep therapy devices recalled for foam that could harm patients using them.

The Class I recall that started in June covers more than 15 million devices, after hundreds of complaints and more than 100 injuries from polyester-based polyurethane (PE-PUR) sound abatement foam that broke down, allowing foam and chemicals to potentially enter the device’s air pathway and cause health problems for users.

On Friday, the FDA said that upon inspection of a Philips Respironics manufacturing facility used to make replacement foam for the recalled devices, it learned that the silicone-based product failed a safety test for the release of volatile organic compounds (VOCs). That test was conducted on a similar device sold outside the U.S.

Get the full story at our sister site, Medical Design & Outsourcing.