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Philips updates on testing results for recalled ventilators

Royal Philips (NYSE:PHG) today provided an update on the test and research program implemented after its major ventilator recall.

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 breaking down. Foam particles could enter a device’s air pathway, causing a range of potential health problems and toxic, carcinogenic effects for the user.

ResMed names Lucile Blaise as new Sleep & Respiratory Care leader

Lucile Blaise will become president of ResMed’s Sleep & Respiratory Care business on July 1. [Photo courtesy of ResMed]

Lucile Blaise will be the new president of ResMed’s Sleep & Respiratory Care business starting July 1, ResMed (NYSE: RMD) said today.

She replaces Jim Hollingshead, who became president and CEO of Insulet (Nasdaq:PODD) on June 1. ResMed President and COO Rob Douglas is serving as interim president of the Sleep & Respiratory Care during the transition.

Blaise is ResMed’s VP of Sleep & Respiratory Care for Western Europe. She joined San Diego-based ResMed in 2006 and has more than 25 years of experience in medical device sales, marketing, finance, and business development, the company said in a news release.

Blaise serves on the MedTech Europe board and was elected president of French medtech association Snitem this month.

ResMed CEO Mick Farrell …

Philips updates on testing results for recalled ventilators

Royal Philips (NYSE:PHG) today provided an update on the test and research program implemented after its major ventilator recall.

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 breaking down. Foam particles could enter a device’s air pathway, causing a range of potential health problems and toxic, carcinogenic effects for the user.

Philips said last year that it wasn’t taking orders for sleep therapy systems as it dealt with the Class I recall that knocked it out of the market for a year. In March, the FDA issued a notification order alerting Philips that its notification efforts on the recall of its ventilators had been inadequate to that point.

In April, the Amsterdam-based company revealed a Department of Justice subpoena f…

ResMed finds a solution to semiconductor shortage, as well as some humor in it

ResMed (NYSE:RMD) can’t go back in time to solve its semiconductor shortage, but it’s found a solution that might be the next best thing — for now.

President and COO Rob Douglas (serving as interim president of Sleep and Respiratory Care at ResMed after Jim Hollingshead left to be CEO of Insulet) offered an update on the San Diego-based company’s supply chain issues as it tries to capture more of the market while Philips works through its recall.

“We’ve been managing a higher than normal rate of decommits coupled with a competitor recall that sucked all the inventory out of our systems and out of all of our customers’ systems as well,” Douglas said Wednesday at the William Blair Growth Stock Conference. “And so there is a huge shortage of devices. … We joke that the head of our supply chain is actually our chief revenue officer because what that person builds, we sell (in terms of devices) as soon as we can.”

Get the full story at our sister si…

ResMed finds a solution to semiconductor shortage, as well as some humor in it

ResMed (NYSE:RMD) can’t go back in time to solve its semiconductor shortage, but it’s found a solution that might be the next best thing — for now.

President and COO Rob Douglas (serving as interim president of Sleep and Respiratory Care at ResMed after Jim Hollingshead left to be CEO of Insulet) offered an update on the San Diego-based company’s supply chain issues as it tries to capture more of the market while Philips works through its recall.

ResMed President and COO Rob Douglas [Photo courtesy of ResMed]

“We’ve been managing a higher than normal rate of decommits coupled with a competitor recall that sucked all the inventory out of our systems and out of all of our customers’ systems as well,” Douglas said Wednesday at the William Blair Growth Stock Conference. “And so there is a huge shortage of devices. … We joke that the head of our supply cha…

Philips names Willem Appelo as chief operations officer

Willem Appelo [Image courtesy of Philips]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 previously worked as the interim supply chain officer and has worked with private equity firms in the medtech industry. Prior to that, he was the VP of supply chain strategy, innovation and development and VP of supply chain medical devices at Johnson & Johnson.

“I am very pleased that Wim Appelo will be joining Philips as our new Chief Operations Officer,” CEO Frans van Houten said in a news release. “Wim brings a wealth of relevant experience to Philips, adding in-depth knowledge and understanding of medical technology and informatics supply ch…

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 breaking down. Foam particles could enter a device’s air pathway, causing a range of potential health problems and toxic, carcinogenic effects for the user.

According to the FDA’s notice, the agency received more than 21,000 medical device reports (MDRs), including 124 reports of death, associated with the PE-PUR foam breakdown or suspected foam breakdown in Philips Respironics’ ventilator devices between April 2021 and April 30, 2022.

Within the MDRs received by FDA — both mandatory reports from Philips and voluntary reports from health…

FDA clears Philips’ MR 7700 imaging system

[Image from Philips]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 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 capabilities with a fully integrated multi-nuclei imaging and spectroscopy solution for exploring new clinical pathways without sacrificing clinical imaging workflow or wide-bore patient comfort.

Philips’ MR 7700 has an easy-to-use interface that allows scientists and clinicians to access the scanner without compromising workflow, offering radiologists a way to image six different clinically relevant nuclei across all anatomies. The platform’s AI-driven smart connected imaging increases diagnostic confidence and adds important metabolic information to MR exams.

The com…

The cloud is transforming medtech: Amazon, Microsoft, Google, J&J, Philips and GE Healthcare leaders explain

[Illustration via Adobe Stock] Leaders in medtech and cloud computing discuss payoffs and potential in device connectivity, product development and cross-industry partnerships.

If knowledge is power, that power comes from a steady stream of information, and we know there’s no shortage of that in healthcare.

The challenge has long been how to capture that information, store it, analyze it and deploy it to improve medical product design, manufacturing and the health of patients.

Then came the cloud, and with it a host of acronyms: software as a service (SaaS), platform as a service (PaaS), infrastructure as a service (IaaS), and — following the same convention — software as a medical device (SaMD).

Over the past few months, Medical Design & Outsourcing connected with leaders in medtech and cloud computing, including the three largest providers of cloud computing services: Amazon (Nasdaq: AMZN), Microsoft (Nasdaq: MSFT) and Google (Nasdaq: GOOGL).…

The cloud is transforming medtech: Amazon, Microsoft, Google, J&J, Philips and GE Healthcare leaders explain

[Illustration via Adobe Stock]

Leaders in medtech and cloud computing discuss payoffs and potential in device connectivity, product development and cross-industry partnerships.

If knowledge is power, that power comes from a steady stream of information, and we know there’s no shortage of that in healthcare.

The challenge has long been how to capture that information, store it, analyze it and deploy it to improve medical product design, manufacturing and the health of patients.

Then came the cloud, and with it a host of acronyms: software as a service (SaaS), platform as a service (PaaS), infrastructure as a service (IaaS), and — following the same convention — software as a medical device (SaMD).

Over the past few months, Medical Design & Outsourcing connected with leaders in medtech and cloud computing, including the three largest providers of cloud computing services: Amazon (Nasda…

May 2022 Issue: The cloud is transforming medtech

The cloud is transforming medtech: Amazon, Microsoft, Google, J&J, Philips and GE Healthcare leaders explain

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Harnessing the power of cloud computing

When Johnson & Johnson and Microsoft announced a deal earlier this year to use cloud computing to support digital surgery, executives on both sides spoke with Medical Design & Outsourcing about how the partnership could advance medtech.

That started a series of conversations with leaders at cloud computing giants Google, Microsoft and Amazon — and on the device side at Johnson & Johnson, Philips and GE Healthcare. We consistently heard that the COVID-19 pandemic accelerated cloud adoption not only for medical records and telehealth, but also for manufacturing operations, supply chain management and making new vaccines, therapies and d…

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 foam breaking down. Foam particles could enter a device’s air pathway, causing a range of potential health problems and toxic, carcinogenic effects for the user.

Get the full story at our sister site, MassDevice.