Aerin Medical today announced published results from a four-year clinical trial of its VivAer treatment for nasal airway obstruction (NAO). Sunnyvale, California–based Aerin designed VivAer, which holds both CE mark and FDA 510(k) approval, to use patented, temperature-controlled radiofrequency energy through a thin, wand-like stylus attached to a console. The stylus is inserted via the […]
Respiratory
GE Healthcare’s Carescape ventilator battery recall is Class I
The FDA issued a notice today labeling the recall of GE Healthcare’s (NYSE:GE) Carescape R860 ventilator as Class I, the most serious kind. GE Healthcare recalled the Carescape R860 ventilator backup batteries, including replacement backup batteries, because the batteries may run out before they are expected to do so. If the ventilator is running on […]
Philips updates on testing results for recalled ventilators
Royal Philips (NYSE:PHG) says only a small portion of returned respiratory devices displayed the sound abatement foam degradation that sparked a massive recall. Repeated ozone cleaning may have made the problem worse. Those were some of the major takeaways from an update Philips provided today on a comprehensive test and research program it implemented after […]
Baxter’s Volara lung therapy system recall is Class I
The FDA issued a notice today labeling the recall of the Baxter (NYSE:BAX) Volara lung therapy system as Class I, the most serious kind. Earlier this month, Baxter announced that it issued an urgent medical device correction for its Volara system for oscillation and lung expansion (OLE) therapy. To date, there has been one complaint […]
Hamilton Medical warns on some ventilators
Hamilton Medical recently issued a field safety notice to warn on issues with some of its Hamilton-C6 ventilators. Analysis of customer complaints revealed a hardware issue related to the status indicator board on the C6 ventilators. The board can become loose and may result in a loose contact to the mainboard and potential oxidation of […]
Draeger has a serious ventilator filter recall
The FDA today issued a notice confirming that a recall of ventilator filters from Draeger is Class I, the most serious kind. Draeger’s SafeStar 55 breathing system filter (model number MP01790), distributed between Aug. 18, 2021, and Oct. 12, 2021, is the affected product. The company initiated the recall on May 9, 2022, and has […]
Aerin Medical closes $60M equity financing
Ear nose and throat (ENT) treatment technology developer Aerin Medical announced today that it closed a $60 million equity financing. Sunnyvale, California-based Aerin’s financing was led by new investor Ally Bridge Group with participation from all existing major investors, including KCK MedTech, Questa Capital and OrbiMed. According to a news release, Aerin Medical intends to […]
ResMed to acquire out-of-hospital software developer Medifox Dan for $1B
ResMed (NYSE:RMD) announced today that it agreed to acquire German software company Medifox Dan in a deal worth $1 billion. Hildesheim, Germany-based Medifox Dan develops clinical, financial and operational software solutions for out-of-hospital care providers. Its offerings include care documentation, personnel planning, administration, billing and more. According to a news release, Medifox Dan’s solutions are […]
ResMed finds a solution to semiconductor shortage, as well as some humor in it
ResMed (NYSE:RMD) can’t go back in time to solve its semiconductor shortage, but it’s found a solution that might be the next best thing — for now. President and COO Rob Douglas (serving as interim president of Sleep and Respiratory Care at ResMed after Jim Hollingshead left to be CEO of Insulet) offered an update on […]
Two-year data backs Aerin Medical’s chronic rhinitis treatment
Aerin Medical announced today that a study of its RhinAer technology demonstrated success in treating chronic rhinitis patients. Sunnyvale, California–based Aerin Medical — one of MassDevice’s 20 medical device startups you need to know in 2020 — designed its RhinAer temperature-controlled radiofrequency (RF) technology to disrupt nerve signals that cause chronic rhinitis symptoms, including constant runny […]
Baxter warns of risks around Volara lung therapy at home
Baxter (NYSE:BAX) announced that it issued an urgent medical device correction for its Volara system for oscillation and lung expansion (OLE) therapy. The warning from Baxter for the Volara system — manufactured by Hillrom, which Baxter acquired for $12.5 billion last year — reinforces important safety information regarding a possible risk of the decrease in […]
