Synapse Biomedical announced that the FDA granted premarket approval (PMA) to its NeuRx diaphragm pacing system (DPS). Oberlin, Ohio-based Synapse designed NeuRx DPS for patients with spinal cord injuries who rely on mechanical ventilation. These spinal cord injury patients can utilize this option when they prefer a more natural method of breathing. Rather than using […]
Respiratory
ResMed chief administrative officer, general counsel to retire, replacement comes from within
ResMed (NYSE:RMD) announced that David Pendarvis, chief administrative officer, global general counsel and secretary, intends to retire. Pendarvis plans to make his retirement effective June 30, 2023. For the remaining six months through Dec. 31, he will remain in a consulting role with ResMed. San Diego-based ResMed plans to conduct an internal search for the […]
Signifier Medical Technologies treats 10,000 patients with wireless, smart sleep apnea therapy
Signifier Medical Technologies announced today that its eXciteOSA treated more than 10,000 patients since its commercial launch in 2021. Boston-based Signifier designed eXciteOSA as a daytime therapy for sleep-disordered breathing. The company says it’s the only such treatment with FDA authorization. The 20-minute daytime therapy allows patients to restore their nighttime breathing naturally. It comes […]
Report: ICU Medical, GE HealthCare to battle over Medtronic units
Reuters reported today that ICU Medical and GE HealthCare are pursuing two business units Medtronic aims to sell off. The outlet cites sources familiar with the situation, saying the companies are looking at Medtronic’s patient monitoring and respiratory interventions businesses. According to Reuters, Medtronic values these businesses between $8 billion and $9 billion. In October, Medtronic […]
FDA OKs Inspire therapy for younger Down syndrome patients
Inspire Medical Systems (NYSE:INSP) announced today that the FDA has approved its implantable Inspire therapy for pediatric Down syndrome patients. “Since our first FDA approval in 2014, the research team at Mass Eye and Ear [Boston], led by Dr. Christopher Hartnick, have pioneered the use of Inspire in this important group of people, and we […]
InspireMD names Andrea Tommasoli as chief operating officer
InspireMD (NYSE:NSPR) this week announced it appointed Andrea Tommasoli as chief operating officer. Tommasoli was previously the company’s senior VP of global sales and marketing since November 2020. Prior to joining InspireMD, Tommasoli was most recently the senior sales director of indirect markets at Integra Lifesciences. “Andrea has been instrumental in expanding the footprint of CGuard […]
Philips names Julia Strandberg chief business leader for connected care business
Philips (NYSE:PHG) announced today that it appointed Julia Strandberg as the chief business leader of its connected care business. Strandberg’s appointment becomes effective April 24, 2023. She joins Philips’ executive committee, reporting to CEO Roy Jakobs. As of April 1, 2023, Philips intends for its connected care business to comprise monitoring, sleep and respiratory care […]
Baxter warns over Life2000 ventilation system
Baxter (NYSE:BAX) issued an urgent medical device correction for its Life2000 ventilation system due to potential oxygen desaturation. Patient oxygen desaturation (low blood oxygen) events can occur under certain conditions. These may happen when the Life2000 system connects with a third-party oxygen concentrator. Hillrom — acquired by Baxter for $12.5 billion in 2021 — manufactures […]
Philips recalls certain reworked Trilogy, Garbin ventilators
The FDA issued a notice labeling the recall of certain Philips (NYSE:PHG) Respironics Trilogy and Garbin ventilators as Class I, the most serious kind This recall relates to Philips Respironics Trilogy 100, Trilogy 200 and Garbin Plus ventilators. Philips had reworked the ventilators as it responded to its massive ongoing CPAP and BiPAP recall. Here’s […]
Medical device report total climbs to near 100,000 in Philips Respironics recall
Philips (NYSE:PHG) has issued an update on its ongoing Respironics recall issues that includes an update on the total reports received. In 2021, Philips initiated a recall involving millions of CPAP and BiPAP ventilators and other respiratory devices for sleep apnea and more. These devices had sound abatement foam that could potentially degrade and get […]
Inspire Medical stock rises on massive Q4 EPS beat
Inspire Medical Systems (NYSE:INSP) shares ticked up today on fourth-quarter results that came in well ahead of the consensus forecast. Shares of INSP were up more than 7% at $268.22 apiece in morning trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — rose more than 13%. […]