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 silicon-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.

“The FDA is aware that patients have already received devices with silicone-based foam as part of the repair and rep…

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Philips wants its suppliers to get serious about climate change

Philips (NYSE: PHG) yesterday said it wants at least half of its supply purchasing to come from companies that commit to science-based targets to reduce carbon dioxide emissions by 2025.

The health technology company said the initiative would be seven times more impactful than Philips’ own carbon dioxide emission reductions.

“Over the last few years, we have made major progress in reducing our own greenhouse gas emissions. We have been carbon neutral in our operations since 2020 and source all of our electricity from renewable sources,” Philips CEO Frans van Houten said in a news release. “We are now using what we have learned to further build out and scale that success with our partners in the supply chain, where the overall environmental impact can even be even greater.”

Based in the Netherlands — a country with about one-third of its surface area below the rising sea level — Philips aims to reduce its own greenhouse gas emission through pr…

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Women researchers receive a fraction of funding from the world’s biggest medtech companies

The gender divide in medtech extends beyond leadership and into funding for investigational studies by U.S. physicians.

Only 6.7% of physicians who received research payments from the world’s largest medical device companies in 2020 were women, according to an analysis of Medical Design & Outsourcing’s Big 100 list of medtech companies and CMS Open Payments data.

Among the 20 medical device companies that fund research by U.S. physicians are 3M, Abbott, BD, Boston Scientific, Johnson & Johnson (dba J&J Surgical Vision and J&J Vision Care), Medtronic (dba Medtronic, Medtronic Minimed, Medtronic USA, Medtronic Vascular), Royal Philips (dba Philips Electronics), Stryker and Zimmer Biomet.

Together, those companies paid $3.9 million to 312 doctors in 2020, but only 21 were women, receiving a collective $402,600.

Women physicians, on average, received 15.7% of payments from each of the top medtech companies, but accounted f…

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ResMed hits supply chain constraints as it responds to major Philips recall

ResMed (NYSE: RMD) saw a dramatic surge in demand for its sleep and respiratory care products after a serious recall knocked competitor Philips out of the market for a year, according to CEO Mick Farrell.

But Farrell also explained during ResMed’s Q4 earnings call yesterday evening that the San Diego–based company is running into supply chain problems as it seeks to respond.

“Global supply chain limitations, including a shortage of electronic components, as well as ongoing freight constraints and costs are impacting our ability to respond to the unprecedented increase in demand for ResMed products,” Farrell said during the call, transcribed by SeekingAlpha. He added that major producers have suggested that chip and electronic components shortages could last 12 or even 18 months.

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

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Philips issues recall for foam component in some sleep and respiratory care devices

Royal Philips (NYSE:PHG) today provided an update on the recall for specific bi-level PAP and CPAP ventilator devices.

On April 26, Philips issued a recall notification for specific Philips bi-level positive airway pressure (bi-level PAP), continuous positive airway pressure (CPAP) and mechanical ventilator devices due to potential risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam component in the devices.

According to a news release, the majority of the affected devices within the advised five-year service life are in the first-generation DreamStation product family. The complaint rate registered at 0.03% in 2020, Philips said.

The Amsterdam-based company determined through testing that there are possible risks to users related to the PE-PUR sound abatement foam component, including the possibility of the foam degrading into particles that may enter the device’s air pathway and be ingested by the user.

Addition…

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Philips launches spectral CT system

Royal Philips (NYSE:PHG) recently launched its Spectral CT 7500 diagnostic imaging system.

Philips designed the system to deliver high-quality spectral images for patients to improve disease characterization and reduce rescans and follow-ups.

“With such great human and financial costs due to misdiagnosis, Spectral CT 7500 sets a new standard of care where image quality, dose and workflow come together to deliver valuable clinical insights. This latest intelligent system helps to bring clarity to defining moments in healthcare by delivering on certainty, simplicity and reliability in every clinical area from cardiac care, to emergency radiology, diagnostic oncology, intervention and radiation oncology,” chief business leader of precision diagnosis Kees Wesdorp said in a news release. “Our detector-based spectral technology ensures spectral data is always available and is seamlessly integrated into current workflows, meaning scans are fast, and clinicians are abl…

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8 medical device companies that beat the COVID-19 pandemic and prospered

[Image from unsplash.com]

Some medical device businesses not only survived the COVID-19 pandemic but actually thrived — with many producing the medtech needed to fight the coronavirus’s spread.

Medical Design & Outsourcing recently analyzed financials for 20 of the largest medical device businesses in the world. Not only was revenue only slightly down for the 20 during 2020, but it was actually up for eight of the 20 companies.

For many of the eight companies that saw sales increase, there was a common theme: They pivoted their focus to the diagnostics imaging and personal protective equipment needed to against COVID-19.

“We had different kinds of companies that were able to benefit on some level from COVID and shutdowns,” Richard Newitter, senior research analyst at SVB Leerink, told MDO.

Overall, medtech sales declined in Q1 and Q2 but then bounced back in a V-shaped recovery fo…

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How big medtech fared during a year of COVID-19

[Photo from Unsplash]

Despite numerous challenges, the medtech industry showed itself to be fairly recession-proof in 2020, according to a Medical Design & Outsourcing analysis of financials.

Annual reports recently released by 20 of the world’s largest medical device companies showed only a slight dip in revenue during 2020 — a year in which medtech held the front lines against the COVID-19 pandemic. Employment was also up slightly amongst the top earners, while R&D spending held its own.

The 20 companies included in the MDO analysis include 3M Healthcare, Abbott (medical device segment), Alcon, Align Technology, Baxter, Boston Scientific, Danaher (life sciences and diagnostics segment), Dentsply Sirona, Edwards Lifesciences, GE Healthcare, Henry Schein, Intuitive Surgical, Johnson & Johnson (medical device segment), Medline Industries, Owens & Minor, Royal Philips, Smith+Nephew, …

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Philips and Disney want to make MRIs easier for children: Here’s how

Image from Philips

Royal Philips (NYSE:PHG) announced today that it is teaming up with Disney to test the effects of custom-made animation to create a relaxing atmosphere for patients.

Amsterdam-based Philips will collaborate with The Walt Disney Company EMEA to see how the animation, including specially-made Disney stories within Philips’ Ambient Experience, creates a relaxing atmosphere to improve both the patient and clinical experience during pediatric MRI procedures, according to a news release.

Disney’s animation features characters like Mickey Mouse, Ariel (The Little Mermaid), Marvel’s Avengers, Yoda (Star Wars) and more. Patients will be allowed to select DIsney content featuring their favorite character to give a sense of familiarity, control and comfort.

The goal of the research pilot is to help alleviate childrens’ anxiety and allow the staff to create bonds…

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