ProSomnus (Nasdaq:OSA) announced today that it completed a $10 million convertible preferred equity offering. The company earmarked the new capital to optimize its core business operations and support its strategic growth initiatives. It aims to achieve cash flow breakeven with these efforts. Spring Mountain Capital and Cetus Capital led the financing. The company’s Executive Chair, […]
Respiratory
Inogen completes Physio-Assist acquisition
Inogen (Nasdaq: INGN) announced today that it completed its previously announced acquisition of Physio-Assist. Goleta, California-based Inogen announced its plan to acquire the French airway clearance technology developer in July. The deal includes a $32 million payment upfront and could reach up to $45 million in total. Physio-Assist develops and manufactures its Simeox technology. Simeox, […]
Inspira submits cardio-pulmonary bypass device for FDA clearance
Inspira Technologies (Nasdaq:IINN) announced that it submitted its Inspira ART100 cardio-pulmonary bypass device for FDA clearance. Ra’anana, Israel-based Inspira designed the system to transform external breathing, empowering breathing without lungs. The company anticipates potential clearance for the system in the first half of 2024. ART100’s bid for 510(k) clearance is backed by a comprehensive usability […]
The Philips CPAP recall settlement could be just be the start
Philips is set to pay at least $479 million to settle claims related to its ongoing Respironics recall. It could just be the beginning of settling what has arguably been one of the medical device industry’s most serious recalls in recent decades. (Here is a full timeline of the Philips recall.) Subject to approval in […]
Inogen CFO steps down, interim replacement named
Inogen (Nasdaq:INGN) today announced that it named Mike Sergesketter as interim CFO after Kristin Caltrider stepped down. Caltrider stepped down from the position, citing personal reasons. Her decision has no relation to any disagreements with the company or its management, operations, policies or practices. The company, which provides respiratory products for the homecare setting, enlisted […]
Philips reaches settlement in class-action lawsuit over sleep apnea machine recall
Philips announced today that it reached a class-action settlement on economic loss claims related to its ongoing Respironics recall. The agreement resolves all economic loss claims in the U.S. multidistrict litigation (MDL) related to the voluntary recall. Philips expects to submit the settlement to the U.S. District Court for the Western District of Pennsylvania later […]
Cardinal Health launches next-gen neonatal feeding device
Cardinal Health announced today that it launched its next-generation NTrainer 2.0 device for neonatal feeding. Dublin, Ohio-based Cardinal Health designed the NTrainer 2.0 to help premature and newborn infants develop oral coordination skills. These skills — important for a speedy transition to independent feeding — helps to reduce NICU length of stay. Through real-time assessment […]
Draeger Medical has another serious ventilator recall
This week, the FDA labeled Draeger’s recall of some ventilators as Class I, the most serious kind. Draeger issued a voluntary correction, not a product removal, of specific Carina sub-acute care ventilators. The company said clinicians may continue to use the devices with adult patients and are instructed not to use the devices with pediatric […]
Paragonix wins FDA clearance for next-gen lung preservation system
Paragonix Technologies announced today that the FDA granted clearance for its next-generation BAROguard donor lung preservation system. BAROguard combines Paragonix’s existing advanced hypothermic preservation technology with automated continuous and active airway pressure control. This ensures that the system maintains an optimal temperature range and a clinically recommended inflation pressure range. It maintains this for donor […]
Philips Respironics has a Class I level ventilators recall
The FDA has posted information on its website about another serious recall involving Philips Respironics products. The news comes the same week that Philips got a vote of confidence from Exor, the investment arm of Italy’s wealthy Agnelli family, which bought a 15% stake in the Dutch medtech giant to become its largest shareholder. Media […]
ResMed shares near 52-week low after disappointing results
ResMed shares are down on fourth-quarter sales and profits that missed Wall Street’s expectations. The device manufacturer’s stock was trading around $183.58 per share near noon, approaching the 52-week low of $181.50. The stock hasn’t closed below $188 since April 2021, when competitor Philips initiated a recall of millions of continuous positive airway pressure (CPAP) […]