Sotera Wireless said it has upgraded its ViSi Mobile patient monitoring system to detect atrial fibrillation, ventricular fibrillation and ventricular tachycardia, and to provide asystole analysis. Often asymptomatic, atrial fibrillation may remain undiagnosed until or even after the development of complications, such as stroke. Post-operative atrial fibrillation is the most common arrhythmia that occurs after […]
FDA slaps Class 1 designation on corneal implant recall
FDA has upgraded a recall of the Raindrop corneal inlay to Class I, the most serious designation. Developed by the now-defunct ReVision Optics, the inlay was designed to treat presbyopia. But 75% of patients in a post-approval surveillance study developed corneal hazing. ReVision closed its doors last year; RVO 2.0, doing business as Optics Medical, […]
Gynesonics touts fibroid study’s long-term outcomes
A long-term retrospective study of patients treated with Gynesonics’ Sonata uterine fibroid treatment system revealed low rates of surgical reintervention, improved symptom severity and quality of life, the company said today. Patients at the study site in Monterrey, Mexico were treated with the Sonata system, designed to provide incisionless transcervical radiofrequency energy ablation of uterine […]
Eargo raises another $52 million for ‘invisible’ hearing aid
Hearing device developer Eargo said it has raised more than $52 million from existing investors and one new one. The Mountain View, Calif.-based company said it will use the money for product innovation, to increase awareness of hearing loss and improve customer experience while expanding its domestic market. Existing investors who contributed to the Series […]
Inspire Medical wins more Blue Cross Blue Shield coverage
Five more Blue Cross Blue Shield health plans have extended coverage to Inspire Medical Systems’ (NYSE:INSP) sleep apnea therapy, the company said today. These plans and the effective dates of their coverage are: Independence Blue Cross, in Pennsylvania, March 4, 2019; Blue Cross Blue Shield of Louisiana, Feb. 20, 2019; Wellmark, in Iowa and South […]
CVS to shut down its hearing aid centers nationwide
(NYSE:CVS) plans to close its hearing centers across the U.S. ahead of an anticipated FDA move to allow the sale of over-the-counter hearing aids. The drugstore chain began offering audiology services in a few stores in Ohio and Texas in 2015, expanding to 50 stores nationwide with the majority in California and Florida, according to […]
Study finds fault with ICD leads that Abbott inherited from St. Jude Medical
A review of FDA adverse event reports has revealed that some Abbott (NYSE:ABT) implantable cardioverter defibrillator (ICD) leads were much more likely than those made by Boston Scientific or Medtronic to fail due to internal insulation breaches (IBR). Researchers at the Minneapolis Heart Institute Foundation combed through the FDA MAUDE database from 2008 to 2018 for reports […]
Klobuchar dinged for medtech industry support
Some patient safety advocates are criticizing U.S. Senator and Democratic presidential contender Amy Klobuchar for favoring medtech companies over consumers, according to a report by the Associated Press and the International Consortium of Investigative Journalists. Klobuchar is in her third term representing Minnesota, one of three major medtech hubs in the United States. The journalism organizations reviewed […]
Wireless preemie monitoring system allows more parental contact
A new, less invasive system for monitoring preterm and critically ill newborns’ vital signs would allow parents skin-to-skin contact with their babies when they otherwise couldn’t have it. The system, designed by researchers at Northwestern University in Chicago, uses ultrathin, skin-like electronic sensing technology to overcome the limitations of traditional systems that require a large […]
How NeuroMetrix seeks to better relieve pain with AI
NeuroMetrix plans to add artificial intelligence to the latest iteration of its Quell transcutaneous electrical nerve stimulation (TENS) device. AI will allow Quell 2.0 to tailor treatment to each individual user, according to the Waltham, Mass.–based based company. Launched in September 2018 Quell 2.0 is 50% smaller and 20% more powerful than the original Quell, […]
FDA warns of potential medical device shortage following Sterigenics plant shutdown
FDA is warning of a possible shortage of sterilized medical devices — and an accompanying threat to public health — due to the recent shutdown of a Sterigenics plant in Willowbrook, Ill. linked to emissions of the highly carcinogenic chemical compound ethylene oxide. Agency officials believe that more than 100 medtech manufacturers and hundreds of devices may be […]
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