Philips begins repair and replacement program for recalled DreamStation devices

Royal Philips (NYSE:PHG) announced today that it initiated repair and replacement programs for its recalled sleep therapy devices.

Amsterdam-based Philips in June issued an urgent medical device recall for its DreamStation continuous positive airway pressure (CPAP) devices, with the FDA classifying the recall as Class I, the most serious kind, in July. The recall has spurred both legal action and congressional scrutiny over recent weeks.

The company confirmed in that month that it is no longer taking orders of sleep therapy systems as it handles the recall, which may knock it out of the sleep therapy market for a year. As a result of the recall, ResMed saw a dramatic surge in demand for its sleep and respiratory care products and is now facing supply chain issues.

More than half the affected DreamStation devices in use globally are in the U.S. Philips said in a news release that it received FDA authorization for the rework of the affected first-generatio…

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MedTech 100 roundup: Industry reaches another high point

The medtech industry is continuing its massive 2021 boom, with the past week marking yet another record in the markets.

MassDevice‘s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished last week (Aug. 27) at 121.05 points, representing a 1.2% rise from the 119.63-point mark set a week before. Following a slight dip earlier this month, the industry continues to tick up to new heights.

Medtech’s performance continues to reflect an overall rebound from the struggles brought on by the COVID-19 pandemic, too. The industry remains well above the marks set around the height of the pandemic, having registered a 31.1% increase from the pre-pandemic high of 92.32 (set on Feb. 19, 2020). Moreover, it remains well ahead of the mid-pandemic low of 62.13 (March 23, 2020) as well, totaling a 94.8% ascent above that point.

The industry’s performance fell in line with the overall markets this past week as the S&P 500 I…

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Philips faces lawsuits, congressional scrutiny over serious sleep devices recall

Royal Philips (NYSE:PHG) is facing scrutiny and legal action amid a serious recall involving millions of its sleep therapy devices.

A number of plaintiffs across the U.S. and Canada have filed class-action lawsuits and personal injury claims in response to the recall, which FDA last month designated the as Class I — the most serious kind  — noting that users of the Philips ventilator devices face a host of health problems and toxic carcinogenic effects. The agency said that there have been more than 1,200 complaints and more than 100 injuries.

Philips is no longer taking orders of sleep therapy systems as it handles the recall, which may knock it out of the sleep therapy market for a year. As a result of the recall, ResMed saw a dramatic surge in demand for its sleep and respiratory care products and is now facing supply chain issues.

A lawsuit filed in Massachusetts by plaintiff Nick Manna kicked off legal actions in June, while a letter sent by Connect…

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MedTech 100 roundup: Industry ticks up again

The medtech industry has been rising for weeks and the latest seven-day stretch was no exception as stocks ticked up again.

MassDevice‘s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished last week (Aug. 6) at 119.41 points, marking a 0.5% rise from the previous week’s tally of 118.86 points (July 30). Not including the  the week in which the index shot up to 145.88 points and quickly tumbled down, the latest marks would represent the index’s all-time best.

Medtech’s performance continues to reflect an overall rebound from the struggles brought on by the COVID-19 pandemic, too. The industry has registered a 29.3% increase from the pre-pandemic high of 92.32 (set on Feb. 19, 2020). Moreover, it remains well ahead of the mid-pandemic low of 62.13 (March 23, 2020) as well, totaling a 92.2% ascent above that point.

The industry’s performance did not correlate with the overall markets this past week as t…

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ResMed hits supply chain constraints as it responds to major Philips recall

ResMed (NYSE: RMD) saw a dramatic surge in demand for its sleep and respiratory care products after a serious recall knocked competitor Philips out of the market for a year, according to CEO Mick Farrell.

But Farrell also explained during ResMed’s Q4 earnings call yesterday evening that the San Diego–based company is running into supply chain problems as it seeks to respond.

“Global supply chain limitations, including a shortage of electronic components, as well as ongoing freight constraints and costs are impacting our ability to respond to the unprecedented increase in demand for ResMed products,” Farrell said during the call, transcribed by SeekingAlpha. He added that major producers have suggested that chip and electronic components shortages could last 12 or even 18 months.

Get the full story on our sister site Medical Design & Outsourcing. 

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ResMed hits supply chain constraints as it responds to major Philips recall

ResMed (NYSE: RMD) saw a dramatic surge in demand for its sleep and respiratory care products after a serious recall knocked competitor Philips out of the market for a year, according to CEO Mick Farrell.

But Farrell also explained during ResMed’s Q4 earnings call yesterday evening that the San Diego–based company is running into supply chain problems as it seeks to respond.

“Global supply chain limitations, including a shortage of electronic components, as well as ongoing freight constraints and costs, are impacting our ability to respond to the unprecedented increase in demand for ResMed products,” Farrell said during the call, transcribed by SeekingAlpha. He added that major producers have suggested that chip and electronic components shortages could last 12 or even 18 months.

Demand is so high that ResMed has had to allocate products in a way that tries to ensure that the patients most in need its ventilators and CPAPs first — the s…

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BREAKING: Philips hit with another Class I-level respiratory devices recall

FDA today announced today another serious recall involving Royal Philips (NYSE:PHG) respiratory devices.

The recall — which Philips Respironics announced in an “Urgent Field Safety Notice” letter on June 18 — involves thousands of V60 Plus ventilators and all V60 ventilators upgraded to enable high flow therapy (software version 3.00 and 3.10). If the oxygen flow is partially blocked for any reason, the system will go on providing the patient with lower oxygen flow rate — issuing a low priority alarm.

FDA said there had been reports of 61 incidents, 25 injuries and no deaths related to the problem. (More information is available on FDA’s website.)

Philips’ letter to customers included instructions such as constant monitoring of patients and urgent response to alarms regardless of their priority. Philips distributed the ventilators involved in the recall from May 1, 2009, to June 2, 2021.

About two weeks ago, FDA issued two other Class …

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MedTech 100 roundup: Industry climbs with earnings season in full swing

The medtech industry remains on the upswing as companies see their stocks rising with quarterly earnings providing a boost.

MassDevice‘s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished last week (July 30) at 118.86 points. Two weeks ago aside — when the index shot up to 145.88 points and quickly tumbled down — this mark would be the index’s all-time best.

The total at the end of last week represents a 2.9% rise from the 115.54-point tally posted by the index at the end of last week (July 23).

Medtech’s performance continues to reflect an overall rebound from the struggles brought on by the COVID-19 pandemic, too. The industry has registered a 28.7% increase from the pre-pandemic high of 92.32 (set on Feb. 19, 2020). Moreover, it remains well ahead of the mid-pandemic low of 62.13 (March 23, 2020) as well, totaling a 91.3% ascent above that point.

The industry’s performance had no cor…

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Recall may have knocked Philips out of sleep devices market for a year

Royal Philips (NYSE:PHG) is no longer taking orders of sleep therapy systems as it handles a serious recall involving millions of the devices.

“As a consequence of the prioritization of the repair or replace actions, we are currently not taking new orders for sleep therapy systems while masks and other consumables, of course, continue to be sold,” CEO Frans van Houten said during a July 26 earnings call, transcribed by Seeking Alpha.

Van Houten said it will take 12 months after regulatory approval to address problems with all the devices, which have a polyester-based polyurethane (PE-PUR) sound abatement foam that could potentially break down and enter a device’s air pathway.

The FDA recently designated the recall as Class I, noting that users of the Philips ventilator devices face a host of health problems and toxic carcinogenic effects. The agency said that there have been more than 1,200 complaints and more than 100 injuries.

“…

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Philips wins breakthrough nod for laser-assisted IVC filter removal device

Royal Philips (NYSE:PHG) announced today that it received FDA breakthrough device designation for its laser-assisted IVC filter removal device.

Amsterdam-based Philips designed its laser-assisted inferior vena cava (IVC) filter removal device to ablate tissue to remove an IVC filter when previous methods of removal have failed, according to a news release.

IVC filters are used for the treatment of venous thromboembolism, with placement in the inferior vena cava to capture blood clots from moving to the heart or lungs. Such filters can have long-term complications, so the FDA recommends that implanting physicians consider removing retrievable IVC filters as soon as they are no longer indicated.

According to Philips, the failure rate for such removal is high and limited options exist if the filter becomes difficult to remove. Dr. Kush R. Desai, associate professor of radiology, surgery & medicine & director of deep venous interventions at Northwest…

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Cognizant to support Philips HealthSuite

Cognizant will use its digital engineering expertise to build and operate client-specific applications on Philips HealthSuite digital health platform, the two companies announced today.

Applications from Cognizant will integrate advanced data analytics to provide relevant data to patients and clinicians at the appropriate point of care. As a result, cognizant and Philips said healthcare providers will better monitor their patients outside traditional clinical settings, and patients can stay more informed. The applications could also quickly provide actionable insights for both biopharmaceutical and medical device manufacturers.

“Partnering with Cognizant’s experienced digital engineering teams will accelerate the adoption of solutions built on Philips HealthSuite, delivering digital solutions across the healthcare continuum in a secure and compliant manner, and ultimately helping guide better health decisions for patients,” Shez Partovi, chief innov…

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Philips enters partnership for stroke tech, enrolls first patient in stroke study

Royal Philips (NYSE:PHG) announced a strategic partnership and a clinical trial milestone for its expanded stroke treatment capabilities.

Amsterdam-based Philips yesterday confirmed a strategic partnership with medtech stroke care company Nico.Lab that will use Philips’ Azurion image-guided therapy system to advance stroke treatment. Additionally, the company announced the enrollment of the first patient in a global stroke study.

In the collaboration, Nico.Lab offers its StrokeViewer cloud-based, end-to-end artificial intelligence-based stroke triage and management solution that seeks to improve patient outcomes by optimizing the stroke workflow.

The platform analyzes CT scan data with AI and automatically detects large vessel occlusion (LVO) and its location before sharing the analysis with physicians at primary stroke centers and intervention centers where the patient eventually receives treatment.

Philips said in a news release that its r…

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