Philips 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 […]
Respiratory
How Philips’ significant respiratory devices recall unfolded
There are 5.5 million recalled CPAPs and other devices — and reports of deaths. Here’s a Philips recall timeline. Philips in mid-2021 kicked off a recall that involved millions of CPAP and BiPAP ventilators and other respiratory devices. The devices — used for sleep apnea therapy and more — had sound abatement foam that could […]
ResMed sees increased sleep device demand, stock rises on Q3 beats
ResMed shares ticked up after hours on third-quarter results that came in ahead of the consensus forecast. Shares of RMD rose more than 4% to $191 apiece after the market closed today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished the day down 1%. The San […]
Exo adds AI-powered cardiac, lung apps to handheld ultrasound
Exo announced today that it launched its FDA-cleared cardiac and lung AI applications for the Iris handheld ultrasound device. The company now has FDA clearance for five different applications on Iris — cardiac, lung, bladder, hip and thyroid. It expects to double that number by 2025. Iris delivers high-performance medical imaging at a fraction of […]
Analysts remain high on ResMed despite potential sleep apnea benefits from GLP-1s
William Blair analysts say that new data supporting the use of GLP-1s in patients with sleep apnea shouldn’t displace companies like ResMed in the market. GLP-1 receptor agonists, like Ozempic and Wegovy, provide therapy for diabetes and can lead to weight loss. Beyond impacting the diabetes industry, questions have arisen over their overall impact on […]
Smiths Medical issues urgent field safety notice for some Portex tracheotomy tubes
ICU Medical’s Smiths Medical this week issued an urgent field safety notice for some of its Portex Blue Line siliconized PVC tracheotomy tubes. The company issued the warning due to an issue related to the neck plate or flange of the Portex Blue Line siliconized PVC tracheotomy tubes. The failure mode can happen during use […]
CPR Therapeutics appoints first chief strategy officer
CPR Therapeutics this week announced it appointed Mike Black as its first chief strategy officer. Black has held numerous leadership roles within the medtech industry. He has over 20 years of executive management experience in the industry and has led early-stage medical device companies through commercialization and successful exit with strategic partners. Most recently, he […]
ICU Medical’s Smiths Medical has a serious ventilators recall
The FDA recently labeled Smiths Medical’s recall of some ventilators as Class I, the most serious kind. ICU Medical’s Smiths Medical initiated a recall of some ASD PneuPac paraPAC Plus 300 and 310 Ventilator kits on February 7. The company said the ventilators may intermittently provide continuous positive gas flow instead of the intended cycling […]
Philips comes to consent decree agreement with DOJ, FDA over Respironics recall
Philips today announced a final agreement on a consent decree with the FDA and U.S. Dept. of Justice (DOJ). The consent decree primarily focuses on its Philips’ Pennsylvania-based Respironics business — the subject of a major recall over the past several years. That includes manufacturing facilities in Murrysville and New Kensington, a service center in […]
Paragonix begins full U.S. launch of donor lung preservation system
Paragonix Technologies announced today that it began the full commercial launch of its Baroguard donor lung preservation system. Baroguard, a first-of-its-kind system, offers an alternative to the current practices. These practices see donor lungs preserved and transported from an inflated state between donor and recipient. Those current organ recovery techniques fail to reliably maintain and […]
LivaNova reports positive study results for neuromod for sleep apnea
LivaNova today announced positive outcomes from a study of its nerve stimulator system for treating sleep apnea. The company said its OSPREY clinical trial achieved a positive predictive outcome and concluded enrollment earlier than anticipated. This means the company projects a greater than 97.5% probability that OSPREY successfully meets its primary endpoint. London-based LivaNova’s OSPREY […]