Electromed today announced it appointed Jim Cunniff as president and CEO, effective July 1. He will replace Kathleen Skarvan, who is retiring after 10 years at the company. Cunniff joins the company with more than 30 years of executive leadership experience in the medtech industry with demonstrated success in general management, sales and marketing, finance, […]
Respiratory
FDA approves Zoll therapy for sleep apnea with MRI
Zoll Medical announced that it received FDA approval for its Remedē system for conditional use with magnetic resonance imaging (MRI). Chelmsford, Massachusetts-based Zoll designed its Remedē system as an implantable, transvenous phrenic nerve stimulation therapy. It treats adults with moderate to severe central sleep apnea (CSA). Full-body MRI approval applies to all models of the […]
Philips: Study shows recalled CPAPs unlikely to cause appreciable harm
Philips (NYSE:PHG) today shared results from a test and research program for the ongoing recall within its Respironics subsidiary. The Amsterdam-based medtech giant says third-party test results determined that issues around its respiratory devices are unlikely to cause appreciable harm to health. These now-completed risk assessments fall in line with results shared by Philips in late […]
Cue Health submits RSV molecular test to FDA for de novo clearance
Cue Health (Nasdaq:HLTH) announced today that it made a de novo submission to the FDA for clearance of its RSV molecular test. The submission aims to garner full clearance of the test for at-home and point-of-care use. According to Cue Health, no respiratory syncytial virus (RSV) tests exist on the market for home use. Pending […]
Inspire Medical grows sales 84% in Q1, raises full-year guidance
Inspire Medical Systems (NYSE:INSP) this week posted first-quarter results that beat the overall consensus on Wall Street. The Minneapolis-based implantable sleep therapy device company reported profit losses of $15.4 million, or 53¢ per share, on sales of $127.9 million for the three months ended March 31, for a sales growth of 84.34% compared to Q1 […]
CorVent Medical appoints Jeremy Nelson as COO
CorVent Medical announced today that it appointed Jeremy Nelson as its new chief operating officer (COO). Fargo, North Dakota-based CorVent says Nelson brings nearly 20 years of operational experience to the role. His expertise comes across supply chain, manufacturing, engineering and automation. He will be based at CorVent’s Fargo office. “We are excited to add […]
ResMed sales up nearly 30% in Q3 amid rising demand
ResMed shares ticked up today on third-quarter results that topped the consensus forecast. Shares of RMD rose 1.2% at $228 apiece before the market opened this morning. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — started the day up 0.2%. The San Deigo-based sleep respiratory technology maker […]
Philips stock rises on Q1 results, recall litigation provision news
Philips reported first-quarter sales growth, plus a litigation update around its ongoing Respironics recall. Shares of PHG ticked up 14% at $21.70 apiece in early-morning trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — rose 0.1%. Sales for the Dutch medtech giant increased by 6% year […]
Avanos Medical has a serious recall of airway access device for young children
The FDA today issued a notice labeling a recall by Avanos Medical (NYSE:AVNS) as Class I, the most serious kind. Avanos’ recall regards its Ballard Access closed suction system for neonates and pediatrics. These affected devices feature the Y-manifold or elbow manifold. Avanos reported four injuries and one death related to the issue with the […]
FDA questions Philips’ replacement respiratory device numbers
The FDA said today that it is clarifying claims by Philips that it has shipped 2.46 million replacement respiratory devices and repair kits in the U.S. The agency claims the number of replacement and remediated CPAPs and other respiratory devices shipped to U.S. consumers is considerably less than the 2.46 million number of “new replacement […]
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 […]
