Inspire Medical Systems announced today that its Inspire therapy has secured its CE mark under the EU’s Medical Device Regulation. Going into effect in 2021, the tighter regulations in the European Union have been a major challenge for medical device companies. With worries growing that medtech companies would pull products out of the EU because […]
sleep apnea
ResMed CPAP masks recall is Class I
The FDA announced that ResMed’s voluntary recall of millions of CPAP mask magnets is now Class I, the agency’s most serious level. Last month, ResMed warned CPAP users about potential magnetic interference when magnets go near certain implants and medical devices in the body. People using CPAP masks with magnets only need to return […]
FDA clears oral device for severe sleep apnea from Vivos Therapeutics
Vivos Therapeutics (Nasdaq:VVOS) announced today that the FDA cleared its removable CARE oral devices for treating severe obstructive sleep apnea (OSA). The CARE (complete airway repositioning and/or expansion) line includes the flagship DNA, mRNA and mmRNA oral appliances. Littleton, Colorado–based Vivos says its clearance makes it the first company bringing a clear alternative to CPAP […]
Inspire Medical Systems revenue misses in Q3
Inspire Medical Systems (NYSE: INSP) reported third-quarter revenue that missed the Wall Street analysts consensus. However, the Minneapolis-based implantable sleep therapy device company also upped its full-year guidance. Investors appeared to focus on the downside after Inspire’s Q3 earnings report yesterday evening. By midday trading today, INSP shares were down more than 16% to $134.90 […]
Inspire Medical wins expanded FDA approval for sleep apnea therapy
Inspire Medical Systems (NYSE:INSP) announced today that the FDA approved an expanded indication for its sleep apnea therapy. Minneapolis-based Inspire develops minimally invasive solutions for patients with obstructive sleep apnea (OSA). The proprietary Inspire therapy is the first and only FDA-approved neurostimulation technology that treats moderate to severe OSA. It offers an alternative to traditional […]
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 […]
Inspire Medical Systems revenue up 71% in Q2
Inspire Medical Systems (NYSE: INSP) easily blew past Wall Street predictions in Q2, though the company is scaling back its gross margin projections. Minneapolis-based Inspire Medical is the maker of a minimally-invasive, implantable, pacemaker-like device that uses neurostimulation to treat obstructive sleep apnea. It announced yesterday evening that it lost $14.5 million, or 53¢ per […]
ResMed part of $28m fundraise for Nyxoah and its neuromod sleep disorder tech
Nyxoah has raised €25 million (nearly $28 million) in its latest fundraising round, with CPAP maker ResMed (NYSE:RMD) joining as a new shareholder. Nyxoah is a Mont-Saint-Guibert, Belgium–based company with a battery-free, leadless and minimally invasive neurostimulator to treat obstructive sleep apnea. It gained a CE Mark for its Genio system last year. Cochlear (ASX:COH) and several […]
Inspire Medical Systems scores win with Blue Cross Blue Shield Association
Inspire Medical Systems – creator of a pacemaker-like system to treat obstructive sleep apnea – said today that the Blue Cross Blue Shield Association’s Evidence Street issued a positive assessment of Inspire therapy to its members. BCBSA is a national federation of 36 Blue Cross and Blue Shield companies. The report from BCBSA, according to Inspire […]
8 crowdfunded health devices you need to know
Companies including 3M and Aura Medical are turning to the popular websites Kickstarter and Indiegogo to get their ideas crowdfunded by people who want them to come to life. The idea behind a crowdfunding website is that if you back the project and donate a certain amount of money, you’ll get something in return, oftentimes […]
This wearable patch detects sleep apnea
A disposable diagnostic patch can detect all types of sleep apnea, according to new clinical trial results. The results showed that the SomnaPatch device had a clinical agreement between the patch and standard polysomnography of 87.4%, with 95% confidence interval of 81.4% to 91.9%, according to its maker Somnarus. SomnaPatch weighs less than 1 ounce […]
