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Philips recalls certain reworked Trilogy, Garbin ventilators

The Trilogy 200 ventilator [Image courtesy of Philips]The FDA issued a notice labeling the recall of certain Philips (NYSE:PHG) Respironics Trilogy and Garbin ventilators as Class I, the most serious kind

This recall relates to the Philips Respironics Trilogy 100, Trilogy 200 and Garbin Plus ventilators. Its impact does not extend to the massive, ongoing CPAP and BiPAP recall.

Here’s a timeline of how the recall unfolded.

Philips also recalled the Trilogy and Garbin ventilators affected by this issue in June 2021, when its Respironics recall began. This recall covers certain reworked ventilators with adhesive issues. The reworked or replaced CPAP and BiPAP machines do not use adhesive to hold the silicone foam in the devices.

In November 2022, Philips warned that reworked Philips Respironics Trilogy ventilators have two new potential issues. The company said the Trilogy 100/200 ventilators with potential additional problems make up roughly 3% o…

Layoffs in medtech: These companies recently reduced their workforce

[Image courtesy of Nastuh Abootalebi on Unsplash] The workforce reduction trend has swept the economy recently, and unfortunately, the medtech space is not immune to layoffs.

You’ve probably read about the ongoing layoffs sweeping the tech industry, media and more.

For instance, Yahoo, Disney, Zoom and more all reported workforce reductions as companies across industries grapple with economic pressures. Think inflation, supply chain challenges and more.

Medtech has shown some resilience in the present environment. Some major medical device companies released positive earnings. However, others announced headcount reductions, citing macroeconomic headwinds. Others felt the weight of regulatory issues and restructuring efforts.

Here are a few companies across medtech that enacted layoffs over the past several months.

In 3M’s fourth-quarter earnings report, the company announced that it plans to reduce its global manufacturing workforc…

Medical device report total climbs to near 100,000 in Philips Respironics recall

The DreamStation CPAP is among the devices involved in Philips’ respiratory devices recall. [Image courtesy of Philips]Philips (NYSE:PHG) today issued an update on its ongoing Respironics recall issues that included an update on total reports received.

In 2021, Philips initiated a recall involving millions of CPAP and BiPAP ventilators and other respiratory devices for sleep apnea and more. These devices had sound abatement foam that could potentially degrade and get into the airways.

Philips Respironics effectively remains out of the sleep therapy market today. The most recent tally associated with reports to the FDA includes 260 deaths. Here’s a timeline of how the recall played out.

In the company’s update issued today, Philips said Respironics relied on an initial, limited data set and toxicological risk assessment. It assumed a “reasonable worst-case scenario” for the potential health risks. Following public statements in April …

Philips plans to reduce global workforce by another 6,000

Philips (NYSE:PHG) reported fourth-quarter results that felt the impact of its massive Respironics recall and supply chain issues.

The company also said it is cutting 6,000 jobs worldwide. The layoff comes on top of a workforce reduction of 4,000 that Philips announced in October. The Dutch medtech giant continues to work through a recall involving millions of CPAPs and other respiratory devices. (Here is a full timeline of the recall.)

Half the cuts will take place this year. The remainder will be done by 2025. The layoffs represent about 13% of Philips’ global workforce.

“Right now, it is very important to lead with realism. I am also a great believer in knowing where I want to go and having a clear plan to get there, a plan that people can understand and have confidence in,” CEO Roy Jakobs said during the company’s earning’s call.

Despite its struggles, Jakobs said he embraced the challenges and that he he was exci…

How the Philips recall is raising scrutiny of at-home medical devices

The DreamStation CPAP is among the devices involved in Philips’ respiratory devices recall. [Image courtesy of Philips]

Philips’ CPAP recall has placed a spotlight on serious communication gaps involving home-use medical devices.

Nonprofit safety organization ECRI recently released its annual Top 10 Health Technology Hazards report. The report said the No. 1 health technology safety issue for 2023 involves communications over medical devices in the home.

The trend of more healthcare services moving to the home is accelerating, according to ECRI. Officials at the group worry that home patients may not receive safety notices that warn of dangerous problems with the medical devices they are using.

ECRI claims that medical device manufacturers seldom directly communicate with people using their devices at home. Worse, healthcare providers may not proactively contact patients about recalls.…

Fresenius Medical Care joins health equity pledge

Fresenius Medical Care announced today that it joined the Zero Health Gaps Pledge at the World Economic Forum in Davos, Switzerland.

As part of the Global Health Equity Network (GHEN), the pledge brings together stakeholders from the public and private sectors. In line with the UN Sustainable Development Goals, they aim to advance a collective vision of “Zero Health Gaps,” making improvements in health equity.

In total, 39 organizations joined the pledge. Medtronic announced yesterday that it took part. Other medtech companies joining include Henry Schein, Hologic and Philips, according to the World Economic Forum.

Fresenius said its involvement marks a commitment to “meaningful action and collaboration toward health equity.”

“We believe that access to equitable and high-quality health care is a fundamental human right, and we are committed to working with global leaders and organizations to improve the lives of millions of…

Philips, Masimo expand patient monitoring partnership with Masimo smart watch

[Image from Masimo]Philips (NYSE:PHG) and Masimo (Nasdaq:MASI) today announced that they expanded their patient monitoring partnership to home telehealth applications.

The companies extended their partnership to augment patient monitoring capabilities at home with the Masimo W1 watch. The advanced health-tracking watch first launched to early adopters in May 2022. It holds CE mark approval while FDA clearance is pending.

This system represents part of Masimo’s recently announced plan to turn home entertainment systems into health hubs.

Philips and Masimo plan to integrate W1 into Philips’ enterprise patient monitoring ecosystem to advance telemonitoring and telehealth. The companies expect to highlight their plans at Arab Health 2023 later this month.

Bilal Muhsin, Chief Operating Officer of Masimo Healthcare, said, “Expanding our partnership with Philips in this way is a win-win for patients and clinicians everywhere, and is an important…

How Philips’ significant respiratory devices recall unfolded

There are 5.5 million recalled CPAPs and other devices — and reports of deaths. Here’s how the Philips Respironics recall got to this point.

Philips in mid-2021 kicked off a recall that involved millions of CPAP and BiPAP ventilators and other respiratory devices. The devices — used for sleep apnea therapy and more — had sound abatement foam that could potentially degrade and get into the airways.

Fast forward a year and a half, and Philips is still effectively out of the respiratory devices market as it works to repair the devices. FDA presently has 90,000 reports of problems — including 260 mentioning deaths.

Philips CEO Roy Jakobs has said the Dutch medtech giant is deeply sorry about the recall.

Meanwhile, competitor ResMed has struggled amid supply chain challenges to fill the resulting CPAP shortage. ResMed CEO Mick Farrell said this week that patients in some parts of the world have to wait up to 12 weeks to receive a CPAP after a sleep apnea diag…

The biggest medtech stock gainers, losers in 2022

(From Ishant Mishra on Unsplash) In another roller coaster year for medtech, these are the companies that saw their stock rise and fall the most drastically.

The MassDevice MedTech 100 Index, which includes stocks of the world’s largest medical device companies, reflects the performance of many in the medtech space.

In a tough year for a lot of businesses, the Index wasn’t immune to struggles. Overall, it dropped 27.3% from this time last year. That compares to a 19.7% drop for the S&P 500 and an 8.9% dip for the Dow Jones Industrial Average.

Some businesses, though, powered through the supply chain- and inflation-related woes to see their stock rise from this time last year. Others weren’t so lucky. Here are some of the biggest gainers and losers — selected from the MedTech 100 Index — of 2022.

Biggest gainers BD — $245.27 to $254.97 — Up 4%

While BD (NYSE:BDX) didn’t have the most significant growth, its stock remains in a …

DeviceTalkers assemble for the final Newsmakers of 2022

In this episode, your diligent team of DeviceTalkers assembled to review our Top 10 events, trends and newsmakers of 2022.

Executive Editor Chris Newmarker, Pharma Editor Brian Buntz, Managing Editor Jim Hammerand, Senior Editor Danielle Kirsh and Associate Editor Sean Whooley joined me, DeviceTalks Editorial Director Tom Salemi, for the latest DeviceTalks podcast.

We’ve got some highs — robots, diabetes — and some lows — supply chain, recalls — and a whole lot of interesting things in between. All-in-all, we’re bullish on what’s to come in 2023! And we only mentioned COVID-19 once.

Companies mentioned in our wide-ranging discussion include Abbott, Abiomed, Ambu, Becton Dickinson, Boston Scientific, CMR Surgical, Dexcom, embecta, Intuitive, Johnson & Johnson Medtech, Medtronic, Neuralink, Philips, Senseonics, Stryker, Synchron, Vicarious Surgical, Zimmer Biomet, ZimVie and many more.

You can listen to other DeviceTalks Podcast Network shows at…

Philips says recalled DreamStation sleep therapy device tests show ‘unlikely’ harm to health

The DreamStation CPAP machine. [Image from Philips’ website]Philips (NYSE:PHG) today issued an update following tests on health risks related to its recalled DreamStation sleep therapy devices.

Amsterdam-based Philips’ testing showed that, among other things, exposure to certain emissions from the recalled devices is “unlikely to result in appreciable harm to health in patients.”

The update marks the latest development in the long recall saga surrounding the company’s Philips Respironics subsidiary.

Last year, Philips stopped taking orders of sleep therapy systems as it handled a Class I recall of certain devices. Respironics recalled millions of ventilators, bi-level positive airway pressure (BiPAP) and continuous positive airway pressure (CPAP) machines.

It attributed the recall to potential health risks caused by polyester-based polyurethane (PE-PUR) sound abatement foam breaking down. Foam particles could enter a dev…

The biggest medtech personnel moves in 2022

Some of the largest companies in medtech have promoted, replaced or removed leaders in recent months.

In July, Medical Design & Outsourcing compiled a list of the biggest personnel changes in the first half of 2022. Those included hirings, firings, promotions and retirements of CEOs, presidents and and other business leaders across the medtech industry.

The latter half of the year has brought even more changes. To close out 2022 and prepare for 2023, here are more of the year’s biggest medtech moves — and some updates since the news first broke.

Butterfly Network CEO steps down

Todd Fruchterman

On Dec. 6, Butterfly Network (NYSE:BFLY) announced that it reached a mutual agreement with Dr. Todd Fuchterman to step down as president and CEO. Fruchterman also left Butterfly’s board of directors.

Fruchterman oversaw Butterfly’s development of artificial intelligence-based ha…