Philips Archives - Page 8 of 19 - Medical Design Sourcing

Philips faces legal scrutiny in France over respiratory devices recall

Problems continue to mount around the massive respiratory device recall at Royal Philips (NYSE:PHG).

Reuters reported today that French prosecutors have opened a preliminary investigation into the recall, citing a text message from a Paris public prosecutor’s office spokesperson.

In the U.S., the FDA and federal prosecutors are increasingly scrutinizing how Philips has handled the deadly recall, which involves more than a million CPAPs, ventilators and other respiratory devices. Philips has effectively been removed from the respiratory devices market for a year as it deals with the recall. Roy Jakobs, the company’s Connected Care chief businesses leader who has been in charge of the recall, is slated to become CEO next month.

Respiratory device problems stem from polyester-based polyurethane sound abatement foam that could break down. Foam particles could enter a device’s air pathway and cause a range of potential health problems and toxic, carcino…

What are the largest medical device companies?

Medtronic, Johnson & Johnson MedTech and Siemens Healthineers top the Big 100 list of largest medical device companies by revenue.

The 2022 edition of MassDevice and Medical Design & Outsourcing‘s Big 100 report also holds surprises. Big conglomerates are spinning out medtech businesses as stand-alone companies, and that means changes to the list of 100 largest medical device companies.

Colfax, for example, engaged in business moves that turned DJO’s parent into Enovis, a large, stand-alone orthopedic device company that is No. 56 in 2022’s Big 100. ZimVie, formerly Zimmer Biomet’s spine and dental business, is 69th. And after decades under larger corporate umbrellas, Cordis debuts at No. 76 on the list.

We collected thousands of data points to size up the industry’s publicly traded companies and privately held firms. The Big 100 includes annual revenue, R&D spending, employee counts, key leaders, headquarters locatio…

Philips Respironics issues updated instructions on CPAP, BiPAP masks

The Philips Amara View full face mask. It is one of the masks affected by the company warning.

Philips (NYSE:PHG) announced that its Respironics subsidiary warned users of certain therapy masks of potential issues with implanted devices.

The company alerted users of certain CPAP or BiPAP therapy masks with magnetic headgear clips or straps. Such devices should not be used by or near patients and their household members, caregivers and bed partners who have metallic implanted devices or metallic objects (such as metallic splinters) in the body.

Philips said the magnetic headgear clips attach headgear straps to the masks. The company noted that this is a “commonly used” method in the sleep therapy devices industry.

This represents the latest addition to the mounting troubles for Philips Respironics. The company has been dealing with a massive recall of CPAP and BiPAP ventilators and other respiratory devices and has been in talks with federal p…

Philips, DOJ settle for $24.8M over Respironics kickback allegations

Philips (NYSE:PHG) today agreed to pay more than $24 million to resolve False Claims Act allegations revolving around kickbacks.

The U.S. Department of Justice (DOJ) alleged that Philips RS North America (formerly Respironics) misled federal healthcare programs by paying kickbacks to durable medical equipment (DME) suppliers. Affected programs included Medicare, Medicaid and TRICARE, the healthcare program for active military and their families.

According to a DOJ release, the settlement resolves allegations that Respironics caused DME suppliers to submit false claims for ventilators, oxygen concentrators, CPAP and BiPAP machines, and other respiratory-related medical equipment because Respironics provided illegal inducements to the DME suppliers. Respironics allegedly gave the DME suppliers data free of charge that could assist in marketing to physicians.

“Paying illegal remuneration to induce patient referrals undermines the integrity of our nation’s h…

Philips to pay $4.2M in DOJ settlement over patient monitoring device modifications

[Image from Philips’ website]Philips (NYSE:PHG) today agreed to pay approximately $4.2 million to resolve allegations of substituting key components of a monitoring device.

The company settled with the U.S. Department of Justice (DOJ) over claims that it substituted the components of its Intellivue MP2 mobile patient monitoring device that it sold to military purchasers without rectifying the device for military airworthiness.

A Philips spokesperson said that, among the company’s discussions with DOJ, it reached the final stages of settlement discussions regarding three separate matters, all of which are related to its connected care portfolio. This is the first of the three settlements to have been announced.

Despite their relation to the connected care portfolio, none of the three settlement discussions are related to the June 2021 Philips Respironics recall, for which the company is also in talks with DOJ.

Acc…

Philips Respironics has a new serious recall for certain ventilators

Philips (NYSE:PHG) has a new FDA Class I recall for its ventilators, adding to recall issues that have plagued the company for a year.

The FDA issued a notice alerting patients, caregivers and providers that certain Philips Respironics bi-level positive airway pressure (BiPAP or BPAP) machines may contain a plastic contaminated with a non-compatible material. If such plastic is in the device motor, it may release certain chemicals of concern called volatile organic compounds (VOCs). It may also cause the machine to fail and stop working suddenly during use.

FDA said the potential risks of inhaling VOCs include headaches, dizziness, irritation in the eyes, nose, respiratory tract and skin, hypersensitivity reactions, nausea or vomiting and toxic and cancer-causing effects. If the plastic causes the machine to fail and stop working suddenly, it may lead to serious injury or death.

At this stage, the FDA is not aware of any reports of serious injury or deat…

10 big earnings stories from the last quarter: How are medtech stocks doing now?

(From Ishant Mishra on Unsplash)

Economic uncertainty appears to have produced a wide variety of medtech earnings stories during the most recent round of quarterly results.

Some medical device companies received massive boosts from their quarterly performance, while others saw their stocks sink amid missed projections and other various issues. The phrase “macroeconomic headwinds” was a common phrase. Medtech faces a strong U.S. dollar (a hurdle for American companies selling overseas), supply chain disruption and inflation.

For all of MassDevice’s medtech earnings stories, click HERE

MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — has mostly been on the rise over this period, getting as high as $90.10 per share (a 6.5% increase from the price of $84.60 at the start of the period). It is now at $85.27 for the last month, representing a 0.7% r…

FDA says 44 more deaths have been reported in Philips ventilator recall

The FDA issued an update to its communication on Philips Respironics’ ventilator recall confirming the reports of 44 more deaths.

Last year, Amsterdam-based Philips (NYSE:PHG) Respironics recalled millions of certain ventilators, bi-level positive airway pressure (BiPAP) and continuous positive airway pressure (CPAP) machines due to potential health risks caused by polyester-based polyurethane (PE-PUR) sound abatement foam breaking down. Foam particles could enter a device’s air pathway, causing a range of potential health problems and toxic, carcinogenic effects for the user.

At the time, the company stopped taking orders of sleep therapy systems as it handled the Class I recall. In March of this year, the FDA told Philips that its notification efforts on the recall of its ventilators had been inadequate to that point.

In April, the company revealed a Department of Justice subpoena for information related to the recall of its respiratory devices. …

Philips names Roy Jakobs as CEO amid ventilator, CPAP recalls

Roy Jakobs is slated to become Philips’s president and CEO, effective October 15. [Image courtesy of Royal Philips]Philips‘ (NYSE:PHG) today announced that Roy Jakobs is proposed to success Frans van Houten as president and CEO, effective October 15.

The Amsterdam-based company’s supervisory board and CEO van Houten have agreed that it is time for a change in leadership as his third term in the corner office comes to an end. The board unanimously decided to propose Jakobs succeed van Houten.

“On behalf of the entire Supervisory Board, I would like to thank Frans for his transformational leadership of Philips over the last nearly 12 years,” said Feike Sijbesma, chairperson of the supervisory board of Royal Philips. “Guided by his vision and the execution of the strategic roadmap, he has successfully led the company’s transformation from a diversified industrial conglomerate into a focused, global solutions leader in health technology. Building on …

Shares dip as supply chain, COVID-19 issues hamper Philips in Q2

Philips (NYSE:PHG) shares took a hit this morning on second-quarter earnings that were adversely affected by supply chain headwinds.

Shares of PHG were down 7.6% at $20.46 per share as the market opened today.

The Amsterdam-based company posted sales of $4.3 billion (Є4.2 billion), representing a 7% decline year-over-year. Philips attributed the revenue dip to continued supply shortages and prolonged lockdowns in China, while inflationary pressures and the Russian-Ukraine war also impacted results.

Profits came in at $11.3 million (Є11 million) for a bottom-line slide of 87.1% from this time last year.

The company’s connected care business saw a 13% sales decrease, mainly as a result of its Respironics recall and the impact of supply chain headwinds. In connection with the recall of CPAP, BiPAP and mechanical ventilators, Philips Respironics has produced 3 million replacement devices and repair kits to date.

Additionally, the company …

The biggest medtech personnel moves so far in 2022

In the ever-changing world of medtech, those who are leading the companies are bound to move around a bit.

At the end of last year, we compiled a list of medtech’s biggest personnel changes in 2021. Throughout just over half of 2022, we’ve already seen a slew of major moves around some of the space’s most powerful players.

Here is a list of some of the biggest personnel changes in medtech so far in 2022:

3M’s healthcare president retires 3M Health Care Business Group President Mojdeh Poul [Image courtesy of 3M]Mojdeh Poul, the president of 3M’s healthcare business, announced in May that she would retire from the position and her retirement was made effective on July 1.

Poul joined 3M in 2011 as the global business VP of critical and chronic care solutions. She later became VP and general manager of the company’s food safety business and president of numerous 3M divisions, including infection prevention, 3M Canada, and sa…

Philips signs onto HHS initiative to reduce greenhouse gas emissions

Philips recently announced that it had joined an initiative created by the Department of Health and Human Services to address climate change by reducing greenhouse gas emissions.

In partnership with the White House, Philips and other health sector organizations and administration leaders participated in a roundtable discussion about work that is being done to combat climate change, as well as other sustainable initiatives.

“A healthy environment is vital for healthy human lives, making this a critical initiative,” Robert Metzke, global head of sustainability at Philips, said in a news release. “At Philips, our purpose is to improve 2.5 billion lives a year by 2030 through meaningful innovation. We have been addressing climate change for many years, teaming up with our partners including our customers and suppliers. We applaud this new HHS/White House initiative and are confident that this pledge will inspire others to commit to take action against this signific…