Philips Archives - Page 7 of 19 - Medical Design Sourcing

Philips seeks new superconducting materials for helium-free MRI scanners

The Philips Ingenia Ambition 1.5T MRI scanner with BlueSeal technology [Image courtesy of Philips]

Royal Philips and superconducting magnetics researchers will seek ways to develop magnetic resonance imaging (MRI) scanners without helium cooling through a new partnership agreement.

Their findings could make MRI scanners smaller, lighter and less expensive to manufacture and operate, increasing patient accessibility. With the world’s limited amount of helium dwindling, suppliers are rationing while medical researchers and healthcare providers hope for long-term solutions.

Philips and other imaging tech manufacturers like GE and Siemens have developed scanning devices that use less helium. New semiconducting materials could eliminate the need for helium in MRI machines.

Through its newly announced deal with MagCorp, Philips will tap the expertise of materials scientists at Florida State Univer…

GE HealthCare, Philips promote role of AI in imaging

The ROCC interface. [Image from Philips]GE HealthCare and Philips (NYSE:PHG) recently announced developments in the area of AI-powered imaging technology.

SIGNA Experience, a GE HealthCare platform including four technologies, helps users through their diagnostic journey. It aims to ensure the smoothest MRI scanning experience for physicians, technologists and patients.

The platform features an intuitive user interface for high-quality MRI, according to a news release. Its deep-learning AI algorithms, including AIR Recon DL, seek to improve signal-to-noise ratio. They also offer improved image sharpness and a shorter scan time, GE HealthCare said.

Automated intelligent workflow technologies and AIR coils offer further improvements in the MRI experience. SIGNA’s workflow allows technologists to keep track of progress at a glance. Its visually-assisted highlighted fields guide them step-by-step and intelligent automation highlights the most likely actio…

More deaths reported in Philips respiratory devices recall

The FDA announced today that it has received more than 90,000 reports of problems — including 260 mentioning deaths — in Philips’ massive respiratory devices recall.

It’s important to note that FDA’s Medical Device Reporting (MDR) system is a passive system with limitations. Still, today’s update from the FDA is but another reminder of the seriousness of the Philips recall. The previous update in late summer listed 69,000 MDR entries since April 2021, including 168 reports of death.

New Philips CEO Roy Jakobs publicly apologized for the Philips Respironics recalls last month. The recalls involve 5.5 million CPAP and BiPAP ventilators and other respiratory devices.

In addition to consent decree talks with the DOJ and FDA, Philips also faces lawsuits.

The recall involves potential health risks caused by polyester-based polyurethane (PE-PUR) sound abatement foam breaking down. Foam particles could enter a device’s air pathway. The p…

Philips’ respiratory devices recall has even more problems

The FDA says some Philips ventilators — reworked as part of the company’s massive respiratory device recall — have new problems.

The Dutch medtech giant has informed the FDA that reworked Philips Respironics Trilogy ventilators have two new potential issues, the FDA said yesterday.

First, the new silicone sound abatement foam could separate from the plastic backing. The separated foam could impact device performance. For example, the silicone foam could potentially block the air inlet, lowering the inspiratory pressure. A ventilator alarm, such as the Low Inspiratory Pressure alarm, could sound. Philips installed silicone foam in the reworked ventilators to replace the polyester-based polyurethane (PE-PUR) foam that could potentially deteriorate and get into air pathways.

In addition, the company reported trace amounts of particulate matter in the air pathway of some reworked ventilators. Particulate samples went to a third-party lab for evaluation…

Philips is cutting its workforce by 4,000

Royal Philips (NYSE: PHG, AEX: PHIA) is launching a significant restructuring amid its serious CPAP recall, supply chain woes and other macroeconomic challenges.

The Dutch medtech giant announced today that it would cut its workforce by roughly 4,000 roles globally — representing about 5% of the headcount listed in its most recent annual report.

The move comes nine days after Roy Jakobs took over the corner office at Philips. Last week, Jakobs publicly apologized for the Philips Respironics recalls. The recalls involve millions of CPAP and BiPAP ventilators and other respiratory devices.

Today, Jakobs said Philips is not living up to shareholder expectations:

“My immediate priority is, therefore, to improve execution so that we can start rebuilding the trust of patients, consumers and customers, as well as shareholders and our other stakeholders. We will do this by first further strengthening our patient safety and quality management and add…

New Philips CEO says he is ‘deeply sorry’ over Respironics recall

Roy Jakobs is slated to become Philips’ president and CEO, effective October 15. [Image courtesy of Royal Philips]Royal Philips’ new CEO Roy Jakobs has apologized for the company’s ongoing massive Respironics recalls.

Since April 2021, the FDA has received more than 69,000 medical device reports, including 168 reports of death, related to sound abatement foam breaking down in CPAP and BiPAP ventilators and other respiratory devices. (Note: The FDA’s MDR system is a passive system with limitations.)

In a recent statement to stakeholders, Jakobs recognized the serious recalls, which involve millions of devices. He said the Dutch medtech giant is taking steps to realign itself with its “people-centered” ideology.

“Delivering on this is what matters most, and that will require us to double down on what we do best, continuing to innovate, but also urgently fixing things where we have disappointed patients and customers. …

FDA clears AI-enabled MR tech from Philips

MRCAT [Image from Philips]Philips (NYSE:PHG) announced today that it received FDA 510(k) clearance for its AI-enabled MRCAT head and neck radiotherapy application.

Amsterdam-based Philips designed its MRCAT head and neck application to allow for the use of MR as the sole or primary imaging modality for radiotherapy planning. It is used for the treatment of soft tissue tumors in the head and neck, along with the brain, pelvis and prostate.

Through a development partnership with MacroMedics, Philips also announced the compatibility of its DSPS Prominent positioning system. DSPS (double shell positioning system) works with the MR head neck coil from Philips. Together, they offer soft tissue imaging capabilities with high-resolution image quality from the head and neck coil. It also features the comfort and positional accuracy and stability of MacroMedics’ masks.

“With this innovative mask that fits into Philips’ head coil, we expect to acquire head and n…

Philips Respironics CPAP, BiPAP mask recall is Class I

[Image from FDA]The FDA today issued a notice confirming that a recall of Philips (NYSE:PHG) Respironics face masks is Class I, the most serious kind.

Last month, Philips provided an update on an issue with its CPAP and BiPap masks. The Respironics subsidiary alerted users of CPAP or BiPAP therapy masks with magnetic headgear clips or straps. The devices could negatively interact with implantable, metallic medical devices.

Respironics has distributed more than 17 million masks containing magnetic clips. As of Aug. 30, the company received 14 reports suggesting that the maks may have impacted implanted devices. The affected masks include the Amara View full face mask, the DreamWisp nasal mask, the DreamWear full face mask, the Wisp and Wisp Youth nasal mask and the Therapy Mask 3100 NC/SP.

According to the FDA, Philips recalled nearly 18.7 million units in the U.S. since initiating the recall on Aug. 2. It distributed the devices between Jan. 1, 2015, and Se…

Philips shareholders approve new CEO

Roy Jakobs is slated to become Philips’ president and CEO, effective October 15. [Image courtesy of Royal Philips]Roy Jakobs has cleared a final hurdle to become Philips’ next CEO, winning shareholder approval during a special meeting today.

The Dutch medtech giant — the fourth-largest in the world according to MassDevice and MDO‘s Big 100 report — announced plans in August for Jakobs to move into the corner office. His appointment is effective October 15.

Jakobs succeeds Frans van Houten, who has been CEO more than 11 years. As CEO, van Houten successfully carved out Philips’ lighting, television, audio and video, and domestic applicants businesses. Along with acquisitions such as the more than $1 billion acquisition of Volcano in 2015, the moves focused Philips on medtech. But as Philips wrestled with a deadly recall that involves more than a million CPAPs, ventilators and other respiratory devices, the company’s supervisory board d…

Another Philips respiratory devices recall receives a Class I label

The FDA announced today that it is labeling another Philips Respironics recall as Class I, its most serious classification.

The new recall involves 386 ventilators distributed from Aug. 6, 2020, to Sept. 1, 2021. The BiPAP machines may contain plastic in their motors that could release volatile organic compounds (VOCs). On top of the risk of users inhaling dangerous VOCs, the plastic could also cause device failure.

At this time, the FDA is not aware of any reports of serious injury or death. The BiPAP machines can treat both adults and children at home and in clinical environments, including hospitals and sleep laboratories.

Mounting troubles for Philips Respironics

The latest serious recall comes as Philips continues to grapple with a deadly recall that involves more than a million CPAPs, ventilators and other respiratory devices. Problems stem from polyester-based polyurethane sound abatement foam that could break down. Foam particles could enter a de…

Philips unveils cloud-based fetal ultrasound tech

[Image from Philips]Philips (NYSE:PHG) announced today that it soon will offer its FetView cloud-based fetal ultrasound image sharing and reporting software.

FetView utilizes ultrasound image data to convey fetal growth projections. The vendor-neutral, cloud-based platform provides a user-friendly platform for communication between physicians and to patients.

Amsterdam-based Philips designed FetView by combining fetal ultrasound imaging with enhanced reporting and easy access to data and images. All results are securely stored and displayed in real-time, according to a news release.

The company said that, by enabling full digitalization of OB/GYN workflows and patient management, Philips FetView will help drive greater departmental efficiency, reduce costs and provide a better patient and staff experience.

“I see multiple patients from many areas in my daily practice, and the implementation of FetView has meant a turbo boost in productivity for my pr…

Philips Foundation, RAD-AID partner to improve ultrasound access

RAD-AID International performing ultrasound training in Liberia. [Image from Philips/RAD-AID]Philips Foundation, together with Philips (NYSE:PHG) and RAD-AID International, today announced a partnership to promote access to ultrasound.

RAD-AID, a U.S.-based non-profit, will leverage Philips’ ultrasound solutions through the collaboration. Philips’ virtual care capabilities will help to provide a scalable, remote training model to improve access to diagnostic and point-of-care ultrasound. The program will feature curriculum-based education and clinical hands-on teaching.

According to a news release, the resources will allow ultrasound experts to communicate with training program participants remotely through voice, video and text messages. They can also view the ultrasound images taken in real-time and remotely demonstrate equipment settings during guided ultrasound exams.

The multi-year, cross-continental partnership will promote access to Phili…