Philips: Study shows recalled CPAPs unlikely to cause appreciable harm

The DreamStation CPAP is among the devices involved in Philips’ respiratory devices recall. [Image courtesy of Philips]Philips (NYSE:PHG) today shared results from a test and research program for the ongoing recall within its Respironics subsidiary.

The Amsterdam-based medtech giant says third-party test results determined that issues around its respiratory devices are unlikely to cause appreciable harm to health. These now-completed risk assessments fall in line with results shared by Philips in late 2022. At that point, testing covered just over two-thirds of registered devices in the recall. To date, risk assessments are complete for approximately 95% of registered devices.

In a news release, CEO Roy Jakobs said Philips’ “first priority” remains the health and well-being of patients. He explained that the test and research program offers clarity on safety and helps provide replacement devices to patients.

“The third-party risk assessmen…

Read more
  • 0

Philips to pay more than $62M to settle FCPA charges

The U.S. SEC announced that Philips (NYSE: PHG) + will pay $62 million to resolve charges that Chinese subsidiaries violated the Foreign Corrupt Practices Act.

The Dutch medtech giant consented to yesterday’s SEC order without admitting or denying the agency’s findings. It’ll pay $15 million in civil penalties and more than $47 million in disgorgement and prejudgment interest.

The SEC’s order claimed that Philips’ China operations engaged in a number of practices that violated FCPA practices.

Philips China used special price discounts with distributors that created a risk that excessive distributor margins could be used to fund improper payments to government employees.

Employees, distributors, or sub-dealers of Philips’ China subsidiaries improperly influenced hospital officials to draft technical specifications in public tenders to favor Philips’ products. For example, the order found that, …

Read more
  • 0

Philips shareholders vote against relieving management of liability

Royal Philips shareholders voiced their displeasure with management’s handling of the company’s massive respiratory device recall at the annual meeting this week.

Shareholders voted down a proposal to relieve the board of management of liability, keeping the potential for investor lawsuits related to the Philips Respironics recall on the table.

“This follows the voting guidance from certain proxy advisors to signal discontent in respect of one former member of the Board of Management,” the company said in a news release, without naming that member.

“We appreciate the support expressed by the shareholders regarding current management and direction of Philips,” Royal Philips Supervisory Board Chair Feike Sijbesma said in the release. “Under the leadership of its new CEO Roy Jakobs, Philips is fully focused on implementing the plan to create value with sustainable impact for our shareholders and all other stakeholde…

Read more
  • 0

Philips launches new image-guided therapy system

The Zenition 10 mobile C-arm system. [Image courtesy of Philips]Philips (NYSE:PHG) announced today that it launched its image-guided therapy mobile C-arm system 1000, called Zenition 10.

The latest edition to the Zenition mobile C-arm series helps to expand patient access to routine surgical care and minimally invasive procedures. Now commercially available, the Zenition 10 utilizes Philips’ state-of-the-art flat panel detector technology for cost-effective, high-quality imaging.

Philips says the mobile C-arm enables surgeons to treat more patients at lower costs while improving outcomes.

“Philips Zenition mobile C-arms have long been recognized for their high-quality imaging and efficiency-enhancing performance. “With the introduction of Zenition 10, we are making those benefits available on a C-arm that meets the wide-ranging needs of routine open and minimally invas…

Read more
  • 0

Philips unveils new Virtual Care Management portfolio

A man takes a blood glucose reading at home as part of the virtual care management portfolio. [Image courtesy of Philips]Philips (NYSE:PHG) announced today that it debuted its Philips Virtual Care Management portfolio of flexible solutions and services.

The Amsterdam-based medtech giant aims to help health systems, providers, payers and employers connect with patients from virtually anywhere. It designed the portfolio to reduce pressure on hospital staff by decreasing emergency department visits and reducing care costs by better managing chronic care.

Philips Virtual Care Management’s condition-specific protocols now include diabetes, hypertension and heart disease. It also covers chronic kidney disease, chronic obstructive pulmonary disease (COPD). Philips also implemented gestational programs for diabetes and hypertension.

These protocols combine with connected devices and engagement tools on a secure, interoperable cloud-based platform. They delive…

Read more
  • 0

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…

Read more
  • 0

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…

Read more
  • 0

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…

Read more
  • 0

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…

Read more
  • 0

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…
Read more
  • 0

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.

Spe…

Read more
  • 0

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…

Read more
  • 0