Philips Archives - Medical Design Sourcing

Philips stock skyrockets on positive outlook, $1.1B Respironics settlement in spite of Q1 misses

Philips (NYSE: PHG) + shares got a huge boost today despite first-quarter results that fell shy of the consensus forecast on Wall Street.

Investors appeared to react positively to recent updates on the company’s long-running Respironics recall. Shares of PHG rose more than 35% to $28.50 apiece in early-morning trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — ticked up 0.5%.

The company’s recent progress with its ongoing Respironics recall included agreeing to a consent decree in the U.S. and receiving a judge’s approval to settle lawsuits related to the economic losses involving millions of recalled CPAP machines. (The economic losses settlement — not to be confused with personal injury claims — was for at least $613 million. Here’s a full timeline of the recall going back to mid-2021.)

Philips said today that it settl…

Philips gets judge’s OK to settle Respironics recall economic losses

Philips (NYSE: PHG) + will pay at least $613 million to settle economic lawsuits related to its recall of millions of CPAPs and other respiratory devices.

U.S. District Court Judge Joy Flowers Conti, who has been overseeing the multidistrict litigation out of her court in Western Pennsylvania, approved the final settlement yesterday.

“The amount of value created and number of persons benefitted favors approval of this award,” Conti said in her order.

“Under the terms of the settlement agreement, there are set payments ranging from $55.63 to $1,552.25 per recalled device … for device payment awards, and $100 per recalled device for device return awards to users. Thus, the non-reversionary $506.3 million refund represents a floor, not a ceiling, and that amount will increase as additional returns of recalled devices are made, and additional claims for device payment awards are filed and app…

Philips receives FDA warning letter over imaging systems manufactured in China

The FDA published a warning letter that it sent to Philips (NYSE: PHG) + that outlines issues around imaging technology manufacturing practices.

During an inspection of a manufacturing facility in Suzhou, China, the FDA determined that the devices are “adultered.” The inspection took place from Oct. 23, 2023, through Oct. 26, 2023. Philips received the letter outlining violations in the manufacturing of the computed tomography (CT) systems on Feb. 23, 2024.

The devices are adultered in that the methods used in, or the facilities or controls used for their manufacture, storage or installation are not in conformity with current good manufacturing practices, the FDA said.

According to the FDA, Philips Head of Quality for the plant, Xin Li, responded to the inspection’s findings on Nov. 17, 2023, and Dec. 18, 2023.

This latest regulatory setback for Philips follows the long-running saga arou…

FDA clears new Zenition 30 mobile C-arm from Philips

The Zenition 30 system in use. [Image courtesy of Philips]Philips (NYSE: PHG) + announced today that the FDA granted 510(k) clearance for its Zenition 30 mobile C-arm.

Zenition 30 reduces the dependency on support personnel by giving surgeons greater flexibility, control and personalization of C-arm movement and user settings. This can help to alleviate staff shortages that limit patient access and increase waiting times. It could also address budgetary constraints that affect today’s hospital systems.

With enhanced workflow efficiency through C-arm control alongside the patient table, surgeons can treat more patients. All the while, they can spend more time focusing on each patient, leading to a better patient and staff experience.

Zenition 30 features Philips’ latest-generation flat detector technology, advanced imaging algorithms and personalized user profiles. It delivers superior image quality, cou…

Philips, AWS expand partnership on digital pathology in the cloud

Philips (NYSE: PHG) + today announced an expanded partnership with Amazon Web Services (AWS) based around digital pathology in the cloud.

The two initially linked up about a year ago, inking a deal to develop generative AI applications. This partnership centered around Philips’ imaging archiving and communications system. It wasn’t the first time a medtech giant linked up with AWS, as GE HealthCare and Baxter also announced similar deals in the past.

Today’s announcement aims to unite Philips’ expertise in the digitization of pathology with AWS’ leadership in scalable, secure cloud solutions.

Together, Philips and AWS hope to advance digital pathology. They want to help labs efficiently store, manage and analyze growing volumes of digital pathology data. This would, in turn, enable the adoption of digital workflows to increase productivity.

Additionally, Philips says patholog…

Philips, SyntheticMR partner on AI-based brain imaging

The Smart Quant Neuro 3D brain imaging platform. [Image courtesy of Philips/SyntheticMR]Philips (NYSE: PHG) + announced today that it launched its Smart Quant Neuro 3D for brain disorder diagnosis and therapy.

The company unveiled the system at ECR2024 in partnership with Swedish MRI software solutions company SyntheticMR. Smart Quant Neuro 3D provides objective decision support for disorders like multiple sclerosis (MS), traumatic brain injury (TBI), and dementia.

According to a news release, the technology provides auto-measurement of various brain tissues. This enhances decision support of rain disease and helps assess progression and monitor the effect of therapy. Its analysis of myelin volumes also provides objective assessments for traumatic brain injuries. Previously, these were only diagnosed through symptom-based tests, Philips says.

The platform combines Philips’ AI-based SmartSmeed image-reconstruc…

Philips unveils new AI-enabled CT imaging tech

The CT 5300 system. [Image courtesy of Philips]Philips (NYSE: PHG) + announced today that it launched its CT 5300 system, a flexible X-ray CT platform with advanced AI capabilities.

Amsterdam-based Philips says the system increases diagnostic confidence, streamlines workflow efficiency and maximizes system up-time. It helps to improve overall patient outcomes and department productivity. Philips unveiled the new system at ECR2024.

CT 5300 meets advanced diagnostic imaging requirements for cardiac care patient guidelines, according to Philips. The company says it also offers utility in other challenging areas like trauma care and interventional procedures. Additionally, the system features virtual tools for real-time collaboration and clinical/technical support.

Philips also designed the system for more accessibility and lower energy consumption.

With Nanopanel Precise, the company’s first detector buil…

Philips tabs Stryker controller as next CFO

Philips proposed to appoint Charlotte Hanneman as its next CFO. [Image courtesy of Philips]Philips (NYSE: PHG) + announced today that it proposes to appoint Charlotte Hanneman as a member of its management board as chief financial officer (CFO).

The Dutch medtech giant proposed to make the appointment effective on Oct. 1, 2024. It must submit its proposal to the annual general meeting of shareholders scheduled for May 7, 2024.

Philips expects to have Hanneman join as a member of its executive committee on June 1, 2024. This begins her induction and transition into the role as she succeeds current CFO Abhijit Bhattacharya on Oct. 1, following his retirement.

Roy Jakobs, CEO of Royal Philips said: “I would like to thank Abhijit for his significant contribution to the transformation of Philips into a health technology company. His dedication and leadership have made a major impact throughout his long 37-year career in…

Philips launches new Azurion neuro biplane system for neurovascular interventions

The Azurion neuro biplane system. [Image courtesy of Philips]Philips (NYSE: PHG) + announced today that it made major enhancements to its Azurion image-guided therapy system with a new launch.

The Amsterdam-based medtech giant unveiled its new Azurion neuro biplane system at ECR 2024. It designed the system to streamline neurovascular procedures and help care teams make the right decisions and do so faster. This enables the treatment of more patients and better outcomes.

Philips’ new interventional system features enhanced 2D and 3D imaging and X-ray detector positioning flexibility. The company believes it enhances both the staff and patient experience and contributes to lower costs for care.

Azurion smooths and optimizes procedure workflows for confident diagnosis and precision treatment. It utilizes the company’s latest Neuro Suite software and services to provide a fully integrated solution. New fea…

Philips unveils radiation-free imaging tech that uses light instead of X-ray

The LumiGuide imaging system in use. [Image courtesy of Philips]Philips (NYSE: PHG) + announced the introduction of its new LumiGuide imaging technology that uses light to help navigate blood vessels.

The company has now made LumiGuide — first used in late 2023 to treat patients in the Netherlands — available to major aortic centers that perform complex aortic repairs in the U.S. and Europe.

LumiGuide offers radiation-free technology, which Philips believes could provide game-changing benefits for complex aortic procedures. Philips said that, for decades, clinicians could only rely on X-ray imaging to guide devices through blood vessels in endovascular procedures. However, in addition to potentially harmful radiation, X-ray only produces 2D black and white images.

With more complex procedures, like aortic aneurysm repair, cases also take more time. That leads to higher radiation doses.

LumiGuide uses light r…

Philips wins FDA nod for latest IntelliVue patient monitor software including Sounds alarm package

The IntelliVue software with Patient Sounds in use at a patient’s bedside. [Image courtesy of Philips]Philips (NYSE: PHG) + announced today that it received FDA 510(k) clearance for its latest IntelliVue patient monitor software.

The latest IntelliVue technology includes several new solutions, including the Philips Sounds alarm package. This clearance means the alarm package now has availability in the U.S. and more than 200 countries worldwide.

Philips worked with clinicians and sound experts to provide a new perspective to acute patient monitor alarms. Together with sound design group SenSound, the company looked to soften and round alarm tones. It also aimed to adjust alarm intervals to more gently signal status or request action using more soothing alarm sounds.

“While alarms in acute care settings must be effective, they should be sensible, informative, and respectful of the surrounding environment and t…

Philips has a serious BrightView recall due to potential falling components

The BrightView imaging system. [Image from Philips]The FDA issued a Class I recall — the most serious kind — for the Philips (NYSE: PHG) + BrightView SPECT imaging systems.

In December 2023, Philips notified customers about a potential issue with BrightView systems (including BrightView, BrightView X and BrightView XCT). Under specific circumstances, the detector may move downward due to a potential component (lead screw) failure. This comes with a risk of contacting the patients, according to a Philips spokesperson.

The FDA described the issue by saying the “detector may unexpectedly fall due to a component failure.” According to the agency, if a detector is positioned below center of the system gantry, there is the potential for abrasion, contusion, laceration and/or fracture to the patient’s lower limbs, as well as an interruption to normal system operation. If the detector is positioned above the cen…