FDA updates medical device shortage list due to shipping delays and semiconductors

Medical device shortages persist due to shipping delays and semiconductor availability, the FDA said last week in an update to its medical device shortage list.

The updated medtech products in short supply include radiological devices, general plastic surgery devices, cardiac diagnostic and monitoring products, general ICU/ hospital products, specimen collection supplies and ventilators.

Philips Invivo MRI breast biopsy grid plates

Philips product shipping delays caused a shortage of magnetic resonance imaging (MRI) breast biopsy grid plates used with breast biopsy/localization trays, surgical guide needles and specialty magnetic resonance coils.

Those Philips Invivo MRI breast biopsy grid plates have been on the shortage list since October 2022 after imaging facilities notified the FDA of the shortage in July. The FDA said it does not know how long the shortage will last, but said it “is still compiling and evaluating data on manufacturing and pro…

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Philips names Julia Strandberg chief business leader for connected care business

Julia Strandberg, new chief business officer for connected care. [Image courtesy of Philips]Philips (NYSE:PHG) announced today that it appointed Julia Strandberg as the chief business leader of its connected care business.

Strandberg’s appointment becomes effective April 24, 2023. She joins Philips’ executive committee, reporting to CEO Roy Jakobs. As of April 1, 2023, Philips intends for its connected care business to comprise monitoring, sleep and respiratory care and enterprise informatics.

Her role could include involvement with the ongoing Philips Respironics recall. Here’s how that recall unfolded. She succeeds Dan Leonard, who took on the role on an interim basis when Jakobs became CEO in October 2022.

Strandberg joins Philips from Pear Therapeutics. At Pear, she served as chief commercial officer, leading the team building, launching and growing Pear’s prescription digital therapeutics.

Before Pear, Strandberg led a he…

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11 of the biggest medtech earnings stories from Q4 2022

(From Ishant Mishra on Unsplash) Layoffs, growth and more — the biggest medtech companies in the world experienced a range of outcomes in the fourth quarter of 2022.

Over the past two months, many of the largest medtech companies across the globe reported their financial results for the three months ended Dec. 31, 2022 (with a handful of exceptions due to different operating calendars).

Some companies offered reasons to feel good about the direction of the medtech industry. Others went in the opposite direction, enforcing workforce reductions and cost-cutting efforts. MassDevice compiled a list of layoffs across the industry, which have now affected more than 19,000 workers.

As layoff news mounted across the industry over the past month, MassDevice‘s MedTech 100 Index declined 2.6%. That was slightly worse than the S&P 500, which was down 2%.

Here are some of the biggest stories from the most recent quarter, all coming from companies within the…

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The biggest cardiology tech stories from ACC.23

Medtronic, Abbott, iRhythm and more presented new data at a major cardiology conference, ACC.23. [Images courtesy of Medtronic, Abbott and iRhythm] Major medtech players presented a range of intriguing studies at a gathering of some of the biggest names in the cardiology tech space.

Some of the hottest topics were covered this past week at the American College of Cardiology’s Annual Scientific Session Together With the World Congress of Cardiology (ACC.23/WCC) in New Orleans.

Ablation, cardiac implants, monitors and imaging technology represented a handful of the technologies on display. Medtronic, Abbott, Boston Scientific, Edwards and more offered new data on their innovative technologies in these areas.

Here are some of the biggest stories that came out of the cardiology conference.

Excitement builds around using pulsed-field ablation to treat AFib

Medtronic, Boston Scientific and Johnson & Johnson MedTech’s Biosense Webster all released new…

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Philips presents positive study results for its cardiology solutions

Philips (NYSE:PHG) today announced various clinical study results validating its innovations in cardiac and cardiovascular care.

Amsterdam-based Philips presented its findings at ACC.23/WCC in New Orleans. Results included trends with intravascular imaging, early cardiac implant removal and intracardiac echocardiography catheters.

“To make a real difference to patients, it is vitally important that medical innovations are validated in real-life clinical practice so that clinician decision-making and guideline setting are firmly evidence-based. At Philips, we are deeply committed to making sure this is the case,” said Dr. Atul Gupta, CMO for image-guided therapy at Philips. “The positive clinical study results announced today are further evidence of how we are continuously working with our clinical partners to co-create new innovations and demonstrate how they improve outcomes for patients.”

Philips evaluates intravascular imaging during percutaneous coronar…
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Philips highlights how it is bringing AI to MR

The MR 7700 imaging system. [Image from Philips]Philips (NYSE:PHG) today announced a range of artificial intelligence (AI)-based offerings it plans to present at the European Congress of Radiology (ECR) 2023.

The Amsterdam-based medtech giant plans to showcase its MR5300 and MR 7700 offerings, as well as its Spectral CT 7500 and Incisive CT with CT Smart Workflow. It also intends to highlight its DXR Smart Workflow, Ultrasound Compact 5000, Ultimate Ultrasound for liver assessment and EPIQ Elite.

MR 5300, powered by AI, simplifies and automates complex clinical and operational tasks to boost MR productivity. It also speeds up exam time and enhances clinical decision-making.

The MR 7700 offers enhanced imaging and speed to support confident diagnosis. It features up to 35% shorter scan time with higher diffusion image quality for all anatomies. MR 7700 also allows radiologists to image six different clinically relevant nuclei across all anatomies.


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How these engineers make DeviceTalks Boston go!

We love engineers here at DeviceTalks.

It’s obvious why. Engineers are the straw that stirs medtech’s drink (apologies to Reggie Jackson). Nothing happens — financing, manufacturing, approval, help for patients — without a well-conceived product.

And engineers often transcend their typical design roles. They grow into business leaders, technology evangelists, startup CEOs, and yes, some stay to lead ground-breaking research and development groups.

So I’m thrilled to be bringing engineers of all types into the agenda of DeviceTalks Boston. We’ll have engineers from Abbott, ZimVie, Philips, Boston Scientific, Stryker and many other companies on hand to talk about being an engineer.

But we’ll also hear from engineers who have followed their careers into other parts of the medical device industry.

In this column, we’ll walk you through some of their career highlights as told in interviews on our DeviceTalks Weekly podcast. We’ll explain t…

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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…

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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…

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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 …

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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…

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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.…

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