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FDA wants more testing in Philips recall

The FDA has issued a communication stating its desire for more testing in the massive respiratory device recall at Philips (NYSE: PHG) + .

The morning after the FDA’s evening announcement, PHG shares were down more than 7% on the NYSE to $18.31 apiece. PHIA shares in Amsterdam closed the day down more than 8%. (MassDevice’s MedTech 100 Index was up slightly.)

Philips has been handling a Class I recall of certain respiratory devices since mid-2021. Respironics recalled millions of ventilators, bi-level positive airway pressure (BiPAP) and continuous positive airway pressure (CPAP) machines. Here’s a timeline of the events of the ongoing saga.

FDA’s statement follows a scathing investigational report from ProPublica and the Pittsburgh Post-Gazette. The report outlined the alleged withholding of information around the issues with the devices even as they became more alarming.

“Th…

Philips reportedly withheld CPAP problems from the FDA for years

Philips (NYSE: PHG) + received the first complaints of degraded sound abatement foam in its respiratory devices in 2010, but 11 years passed before it turned into a major recall, according to a ProPublica and Pittsburgh Post-Gazette investigation published today.

According to ProPublica, Philips withheld the vast majority of the warnings about black particles, dirt, dust and other contaminants in devices airway chambers from the FDA even as the reports became more alarming each year.

It wasn’t until 2021 that Philips initiated a recall that now covers 5.5 million CPAPs and other devices. Since April 2021, the FDA received 105,000 reports of problems, including 385 reports of deaths associated with the foam degradation issue. (Here is MassDevice‘s full timeline of the recall.) After he took over in 2022, Philips CEO Roy Jakobs apologized for the recall on behalf of the Dutch medtech giant is deeply sorry ab…

Philips expands mobile C-arm offering with Zenition 30

The Zenition 30 image-guided therapy system. [Image courtesy of Philips]Philips (NYSE: PHG) + today announced the launch of its new Zenition 30 image-guided therapy mobile C-arm system 3000.

Zenition 30 marks the latest addition to the company’s versatile Zenition mobile C-arm series. The Amsterdam-based company unveiled its Zenition 10 version earlier this year. The mobile-C arm X-ray systems provide live image guidance during a range of clinical procedures in the operating room. They contribute to orthopedics, trauma, spine, pain management and other surgical procedures.

Philips said in a news release that Zenition 30 offers surgeons a greater level of control, autonomy and independence in these operations. By reducing dependency on support staff, Zenition 30 helps to alleviate the staff shortages faced by many hospitals. It also features workflow enhancements and high-quality images that enable high-quality care …

Philips launches utrasound tech to boost cancer diagnostics

Microvascular imaging super-resolution CEUS enables much better spatial resolution than previous models, according to Philips. [Image courtesy of Philips]Philips (NYSE: PHG) + recently announced that it has incorporated a super-resolution contrast-enhanced ultrasound (CEUS) application into its EPIQ Elite ultrasound system.

The addition of microvascular imaging super-resolution CEUS enables three times better spatial resolution than previous models, according to Philips. It could potentially improve the diagnostic accuracy for assessing lesion blood flow in cancer patients.

Understanding blood flow dynamics around a tumor is crucial for cancer diagnostics. For instance, the blood flow in and around a liver tumor can provide clues regarding the potential for the cancer to spread. Traditionally, clinicians use an iodinated contrast medium for these assessments. However, some patients experience intolerance to the iodinated …

The Philips CPAP recall settlement could be just be the start

Philips (NYSE: PHG) + is set to pay at least $479 million to settle claims related to its ongoing Respironics recall.

It could just be the beginning of settling what has arguably been one of the medical device industry’s most serious recalls in recent decades. (Here is a full timeline of the Philips recall.)

Subject to approval in the U.S. District Court in Western Pennsylvania, the deal only covers economic losses incurred by the users of millions of Philips CPAPs and other respiratory devices recalled over sound abatement foam that could potentially degrade and get into airways. The $479 million amount is the minimum that Philips has agreed to pay.

“This uncapped settlement is one of the largest consumer class action settlements ever negotiated, and I expect it will be worth substantially more than the prefunded amounts as more users of recalled Philips devices enroll in the settlement and seek out compe…

Philips reaches settlement in class-action lawsuit over sleep apnea machine recall

The DreamStation CPAP is among the devices involved in Philips’ respiratory devices recall. [Image courtesy of Philips]Philips (NYSE: PHG) + announced today that it reached a class-action settlement on economic loss claims related to its ongoing Respironics recall.

The agreement resolves all economic loss claims in the U.S. multidistrict litigation (MDL) related to the voluntary recall. Philips expects to submit the settlement to the U.S. District Court for the Western District of Pennsylvania later today, Sept. 7. Subject to court approval, the settlement includes no admission of liability, wrongdoing or fault by any of the Philips parties.

A press release from the co-lead plaintiffs counsel — Sandra L. Duggan of Levin Sedran & Berman LLP; Kelly K. Iverson of Lynch Carpenter LLP; Christopher A. Seeger of Seeger Weiss LLP; and Steven A. Schwartz of Chimicles Schwartz Kriner & Donaldson-Smith LLP — stated that Phil…

Philips prices $546.2M offering to repay existing debt

Philips (NYSE: PHG) + announced today that it priced a fixed-rate notes offering worth $546.2 million (€500 million).

Amsterdam-based Philips priced the notes (due 2031) under its European medium-term note (EMTN) program. The issue of the notes has a debt-neutral effect.

Philips said in a news release that it intends to use the net proceeds to repay debt. This debt comes from the funds utilized and outstanding under the credit facility entered into in the fourth quarter of 2022. Other uses of proceeds include general company purposes.

The company set the issue price for the notes at 99.741% with a coupon of 4.25%, resulting in a 4.289% yield. Philips said the offering was two times oversubscribed. It scheduled the settlement and issue of the notes for Sept. 8. The company also applied for the listing of the notes on the Official List of the Luxembourg Stock Exchange and to be traded on the regulated market of th…

What are the largest medical device companies?

Medtronic, Johnson & Johnson MedTech and Siemens Healthineers again lead the Medtech Big 100 list of largest medical device companies.

However, there is so much more to Medical Design & Outsourcing and MassDevice‘s 2023 edition of the Medtech Big 100 report. We pulled thousands of data points to provide information on annual revenue, R&D spending, headcount, CEOs and key leaders, headquarters locations and descriptions of each of the 100 largest medical device companies.

Senior Editor Danielle Kirsh’s analysis shows that even as the largest medtech companies engaged in layoffs over the past year, they also made a bet on innovation to boost future growth: R&D spending increased nearly 13% to $26.4 billion. (Read the full story on MDO.)

In addition, the full Medtech Big 100 list includes already completed medtech company spinoffs such as Embecta , GE HealthCare and ZimVie.

Read the full Medtech Big 100 report to find out …

Philips says extended ECG Holter monitoring can improve diagnostic results

The ePatch extended-wear Holter ECG monitor. [Image from Philips]Philips (NYSE: PHG) + today shared data supporting the use of its extended-wear Holter electrocardiography (ECG) monitor.

The Amsterdam-based company presented the findings at the European Society of Cardiology Congress in Amsterdam. Results showed how specific diagnostic referral codes can potentially help to pre-determine how long a cardiology patient should receive mobile telemetry, or Holter monitoring, to monitor their symptoms remotely and possibly prevent further hospitalization.

Conventional Holter monitoring, analysis and reporting often prove labor-intensive and inefficient with potential high costs. The inconvenient process can include long turnaround times and negatively affected patient compliance and satisfaction. Philips designed its extended-wear Holter monitor, the ePatch, for several days of continuous monitoring.

Philips acquired eP…

Philips warns on potential unintended radiation with imaging systems

Philips (NYSE: PHG) + issued an urgent field safety notice in Europe regarding a potential issue with some of its imaging systems.

The issue pertains to the wired and wireless foot switches used with the Philips Allura Xper, Allura Centron, Azurion and the MultiDiagnost-Eleva systems. It could lead to unintended radiation, according to the notice filed in Europe this month.

Philips’ notice says the foot switches control fluoroscopy, exposure and other functions. These include single shot, light control and toggle between X-ray planes. A foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in unintended radiation. The company received no reports of harm related to the issue.

This issue can occur with a build-up of dense or sticky fluids on the switch if not properly cleaned. Philips also said it may happen with the use of protective covers that are the wrong siz…

Philips Respironics has a Class I level ventilators recall

The FDA has posted information on its website about another serious recall involving Philips Respironics products.

This time, the Class I recall covers 73,000 Philips Respironics Trilogy Evo, Evo O2, EV300, and Evo Universal ventilators in the U.S. It’s the Philips subsidiary’s 11th serious recall listed on the FDA’s Medical Device Recalls webpage since 2021 — when a global recall involving millions of CPAPs and other respiratory products with potentially degraded sound abatement foam sidelined the Dutch medtech giant from the market.

According to the FDA, Philips initiated the recall of Trilogy Evo, Evo O2, EV300, and Evo Universal ventilators on March 22 after detecting dust and dirt from the environment in the air path of some devices. Extended exposure to environmental contaminants such as dust and dirt can lead to buildup that may block air vents and cause the device to stop delivering the right amount of air pressure or air volume/flow.…

ResMed shares near 52-week low after disappointing results

ResMed (NYSE: RMD) + shares are down on fourth-quarter sales and profits that missed Wall Street’s expectations.

The device manufacturer’s stock was trading around $183.58 per share near noon, approaching the 52-week low of $181.50.

The stock hasn’t closed below $188 since April 2021, when competitor Philips initiated a recall of millions of continuous positive airway pressure (CPAP) devices. ResMed has had the CPAP device market to itself since then.

MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — is relatively unchanged today.

The San Deigo–based sleep respiratory technology maker posted profits of $228.7 million. That amounts to $1.56 per share on sales of $1.12 billion for the quarter ended June 30, 2023.

ResMed profits decreased 18% compared to the prior-year quarter but posted sales growth of 23%.

Adjusted to e…