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…

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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…

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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…

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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…

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Fresenius Medical Care hires replacement for longtime CEO

Carla Kriwet will become CEO of Fresenius Medical Care [Photo courtesy of Fresenius]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 have put their trust in us a little more worth living every day,” Kriwet said in a news release yesterday. “And I’m convinced that bringing ever better medicine to ever more people goes hand in hand with economic success.”

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

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Fresenius Medical Care hires replacement for longtime CEO

Carla Kriwet will become CEO of Fresenius Medical Care [Photo courtesy of Fresenius]

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 have put their trust in us a little more worth living every day,” Kriwet said in a news release yesterday. “And I’m convinced that bringing ever better medicine to ever more people goes hand in hand with economic success.”

Fresenius CFO and CTO Helen Giza will assume the position of deputy CEO and enter into a new 5-year employment contract, the company said.

Kriwet served as CEO and president of BSH Hausgeräte (Home Appliances) GmbH from July 2020 until she stepped down for her ne…

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Medtech CEOs sound off on semiconductor shortage, pushing Biden administration for prioritization

BD CEO, President and Chair Tom Polen [Photo courtesy of BD]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 our industry and to the countless patients who depend on the medical technologies we produce,” AdvaMed President and CEO Scott Whitaker said during the meeting, according to a readout. “In this challenging environment, we simply cannot compete with larger players to gain access to chips.”

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

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Medtech CEOs sound off on semiconductor shortage, pushing Biden administration for prioritization

BD CEO, President and Chair Tom Polen [Photo courtesy of BD]

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 our industry and to the countless patients who depend on the medical technologies we produce,” AdvaMed President and CEO Scott Whitaker said during the meeting, according to a readout. “In this challenging environment, we simply cannot compete with larger players to gain access to chips.”

Medical device manufacturers buy about 1 percent of the world’s semiconductors, the trade group has said. That small share is difficult for the industry to leverage wit…

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FDA may order Philips to resolve respiratory devices recall

The FDA proposed that an order should be issued to require Philips (NYSE:PHG) to submit a plan for its recalled respiratory devices.

FDA’s proposal regards the June 2021 recall 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.

Amsterdam-based Philips said last summer that it was no longer taking orders of sleep therapy systems as it handled the Class I recall, which knocked it out of the sleep therapy market for at least a year. In March, the FDA issued a notification order alerting Philips that its notification efforts on the recall of its ventilators have been inadequate to date.

Last week, the company disclosed a Department…

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DOJ subpoenas Philips over Respironics recall; CEO addresses investigation

Royal Philips CEO Frans van Houten [Photo courtesy of Philips]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 and operating results. Phillips said its subsidiaries are cooperating with investigators.

“At this time, it’s a subpoena for information,” CEO Frans van Houten said on today’s earnings call. “That means they are preparing an investigation, and we just have to accept that.”

Philips shares dropped about 12% in trading Monday as the company detailed continued supply chain struggles and mounting recall costs.

Van Houten said Phillips remains in close collaboration and contact with regulatory agencies.

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DOJ subpoenas Philips over Respironics recall; CEO addresses investigation

Royal Philips CEO Frans van Houten [Photo courtesy of Philips]

Royal Philips (NYSE:PHG) today disclosed a Department of Justice subpeona 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 and operating results. Phillips said its subsidiaries are cooperating with investigators.

“At this time it’s a subpeoena for information,” CEO Frans van Houten said on today’s earnings call. “That means they are preparing an investigation and we just have to accept that.”

Philips shares dropped about 12% in trading Monday as the company detailed continued supply chain struggles and mounting recall costs.<…

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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 day.

The Amsterdam-based company posted losses of $161.8 million (€151 million), or 18¢ (€0.17) per share, on sales of $4.2 billion (€3.9 billion) for the three months ended March 31, 2022, for a bottom-line slide into the red on sales growth of 2.4%.

Adjusted to exclude one-time items, earnings per share came in at 16¢ (€0.15).

Philips CEO Frans van Houten said in a news release that the company’s results came in “challenging circumstances” with significant supply chain headwinds and the consequences of its ongoing issues with ventilator recalls.

Additionally, van Houten said th…

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