Philips Archives - Page 2 of 19 - Medical Design Sourcing

The top medtech trends of 2023

The top medtech trends of 2023 included innovations such as artificial intelligence, new GLP-1 weight loss drugs and some long-awaited medtech finally receiving regulatory nods.

With health providers facing additional challenges on top of an ever-uncertain economic environment, medtech companies also made major readjustments: layoffs, spinoffs, reorganizations and much more.

Here are the top stories that caught the attention of MassDevice readers and editors in 2023.

Top 2023 medtech trend No. 10: Questions about GLP-1 drugs

U.S. health providers wrote more than 9 million prescriptions in just three months for Wegovy, Ozempic and similar glucagon-like peptide-1 (GLP-1) weight loss drugs, according to analytics firm Trilliant Health. The popularity and initial effectiveness of the new drugs had medtech industry analysts asking a lot of questions about how the potential health benefits could reduce demand for devices. Medical device executives, however, we…

Philips’ BioTelemetry to pay $14.7M to settle false claims violation allegations

Philips’ (NYSE: PHG) + BioTelemetry and its LifeWatch subsidiary agreed to pay more than $14.7 million over False Claims Act violation allegations.

Philips acquired BioTelemetry in a $2.8 billion deal in 2021.

The BioTelemetry subsidiary settled allegations of knowingly submitting claims to federal healthcare programs for a higher level of remote cardiac monitoring than physicians intended to order, or that was medically necessary. This inflated the level of reimbursement paid to LifeWatch, according to the U.S. Dept. of Justice (DOJ).

DOJ’s allegations center around the period between July 1, 2014, and Dec. 31, 2020, and the LifeWatch ACT-3L device. It says LifeWatch marketed the device to doctors as capable of performing three different types of heart monitoring services. According to DOJ, the BioTelemetry subsidiary marketed holter monitoring, event monitoring and telemetry.

Of these, telem…

U.S. senators call for review of FDA following Philips recall fallout

[Image by f11photo via stock.adobe.com]Two U.S. senators sent a letter calling on the government to review the FDA’s oversight of medical device recalls amid the ongoing Philips Philips (NYSE: PHG) + Respironics recall.

Majority Whip Dick Durbin (D-IL) and Sen. Richard Blumenthal (D-CT) sent the letter to the Government Accountability Office (GAO). The letter requests an update to a 2011 GAO report entitled “Medical Devices: FDA Should Enhance Its Oversight of Recalls.”

Durbin and Blumenthal’s scrutiny of FDA oversight comes in the wake of several developments in Philips’ respiratory device recall.

Since mid-2021, more than 5 million Philips Respironics devices have been recalled due to dangerous degradation of sound abatement foam. At least 385 deaths have been reported in connection with the foam-related recall.

While the company continues to work though its remediation process, mor…

FDA warns of thermal issues with Philips DreamStation 2 CPAP machines

The Philips DreamStation 2 continuous positive airway pressure (CPAP) device [Photo courtesy of Philips]The FDA is warning patients and health care providers to watch Philips (NYSE: PHG) + DreamStation 2 continuous positive airway pressure (CPAP) machines for signs of overheating.

The medical device safety agency said it recently received an influx of medical device reports (MDRs) associated with thermal issues such as fire, smoke, burns, and other signs of overheating while patients were using the devices.

It’s the latest safety warning for Philips respiratory devices, of which more than 5 million have been recalled for dangerous degradation of sound abatement foam. At least 385 deaths have been reported in connection with the foam-related recall.

“Consumers should be aware some DreamStation 2 CPAP machines were distributed as replacements for recalled DreamStation 1 CPAP machines,” the FDA said.…

Philips unveils next-gen ultrasound systems

A clinician uses the EPIQ Elite VM10 ultrasound system. [Image courtesy of Philips]Philips (NYSE: PHG) + today highlighted the capabilities its next-generation EPIQ Elite and Affinity ultrasound systems.

The new systems feature automated tools and a common user interface with transducer compatibility across Philips ultrasound systems. That includes the recently introduced Compact Ultrasound 5000 Series. Amsterdam-based Philips says its latest advances demonstrate a positive impact on patient and staff satisfaction. It designed the ultrasound technologies help to improve workflow and provide greater scanning efficiency.

“Our next-generation ultrasound systems EPIQ and Affiniti address the challenges healthcare systems face every day in dealing with more patients with more complex conditions while enhancing operational efficiency and reducing costs,…

Philips inks multi-year health technology deal with NYU Langone Health

NYU Langone Health. [Image courtesy of NYU Langone Health/Philips]Philips (NYSE: PHG) + announced an eight-year strategic partnership with NYU Langone Health to enhance patient care through innovation.

Philips values the deal with NYU Langone, ranked the nation’s top academic medical center by Vizient, at up to $115 million. The company aims to offer new technologies for clinicians to collaborate in real time. This extends to sharing pathology, imaging studies or patient data to support diagnostic confidence and tailor individualized care plans.

According to a news release, they expect the integrated, collaborative approach to further enhance the patient experience. Philips and NYU Langone anticipate faster diagnosis and treatment, plus improved outcomes as a result.

Philips Chief Business Leader for Connected Care, Julia Strandberg, called NYU Langone a “trailblazer” for technology adoption.

…

Philips picks up funding from Gates Foundation for AI-powered maternal health ultrasound

The Lumify handheld ultrasound system in use. [Image courtesy of Philips]Philips (NYSE: PHG) + announced today that it received a second round of funding from the Bill & Melinda Gates Foundation for its ultrasound technology.

The funding goes toward accelerating the global adoption of AI algorithms on the Philips Lumify handheld ultrasound system.

Philips’ system utilizes AI to simplify key measurements to identify abnormalities during pregnancy. This can reduce training time to use the ultrasound system from weeks to hours. The company said that expands the pool of frontline health workers who can learn to use the technology and integrate it into routine care.

In 2021, the Bill & Melinda Gates Foundation provided its first phase of grant funding. Philips said it’s seen a positive impact in Kenya, where the technology helped to triage pregnant women in rural, underserved communities. The latest …

Philips CEO Roy Jakobs reportedly approved continued sale of defective sleep respiratory devices

Philips CEO Roy Jakobs [Image courtesy of Royal Philips]A new report from ProPublica and the Pittsburgh Post-Gazette claims to shed more light on the alleged role of Philips (NYSE: PHG) + CEO Roy Jakobs in the ongoing Respironics recall.

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. This timeline lays out the events of the ongoing saga.

ProPublica and the Post-Gazette previously released a scathing investigation outlining the alleged withholding of information around the issues with the devices even as they became more alarming.

The latest from the news outlets says the company decided to stop shipping defective devices in April 2021 after tests showed exposure to potentially dangerous particles. Philips alerted the FDA to the po…

ResMed is cutting its workforce as it seeks to refocus

ResMed (NYSE: RMD) + announced that it is reducing its workforce by about 5% as part of a restructuring it plans to complete in the present quarter.

The San Diego–based maker of CPAPs and other respiratory devices listed a headcount of 8,160 in its most recent annual report, which means roughly 400 workers could be affected.

“Decisions like this that impact people are never easy. However, we know that we are doing the right thing, and we’re doing the right thing to accelerate our growth and to refocus on our long-term mission,” CEO Mick Farrell said during the company’s earnings call yesterday evening.

ResMed has seen its revenue spike amid the massive recall at competitor Philips, but the growth may be slowing. Revenue was up 16% year-over-year to $1.1 billion in the first quarter that ended Sept. 30, 2023. It was up 23% in the previous quarter.

“We have stopped some project…

PCI guidance tech from Philips delivers positive study results

iFR technology. [Image courtesy of Philips]Philips (NYSE: PHG) + today announced study results supporting its instant wave-free ratio (iFR) in guiding percutaneous coronary intervention (PCI).

Amsterdam-based Philips offers iFR as a pressure-derived index to assess coronary blockages during interventional procedures. iFR avoids the use of hyperemic agents — drugs that maximize blood flow but can impact the patient experience.

Dr. Matthias Götberg presented results from a longitudinal analysis at the 35th annual Transcatheter Cardiovascular Therapeutics (TCT) symposium. Götberg works in the Dept. of Cardiology, Clinical Sciences at Lund University, Sweden.

The study looked at the National Swedeheart Quality Registry of more than 42,000 patients undergoing coronary procedures. Results demonstrated no difference between iFR and fractional flow reserve (FFR) in major adverse cardiac events (MACE).

Judge grants preliminary approval to Philips class action settlement

[Image from Pixabay]A federal judge in Pennsylvania has granted preliminary approval to an economic loss settlement involving lawsuits filed against Philips over its massive recall of CPAPs and other respiratory devices.

U.S. District Court Judge Joy Flowers Conti’s order, filed yesterday, 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.)

According to plaintiffs’ co-lead counsel, Philips has agreed to provide at least $479 million in compensation to device users who paid out of pocket to buy or rent the recalled devices, as well as payers who reimbursed users for the devices. Awards could range between $55.63 and $1,552.25 for each recalled device, plus a $100 award apiece for those who returned devices.

“We are pleased that Judge Conti granted preliminary approval of the Philips economic loss settlement and encou…

Philips takes steps to improve health monitoring, care coordination with open ecosystem

[Image courtesy of Philips]Philips (NYSE: PHG) + today announced interoperability between its Philips Capsule and Philips Patient Information Center iX (PIC iX).

Interoperability between the Capsule medical device information platform (MDIP) and PIC iX offers hospitals a first-of-its-kind, comprehensive patient overview. Philips aims to create an open patient monitoring ecosystem, bringing together disparate devices and systems on a single interface.

In early 2021, Philips acquired Capsule Technologies in a deal worth $635 million. This technology now helps to enable the interoperability the company is offering. Speaking to MassDevice at The MedTech Conference, Julia Strandberg, chief business leader of monitoring & connected care, explained what this open ecosystem offers.

“The intention is to have vendor-neutral data coming in, in real-time and waveform data,” Strandberg said. “There’s…