sleep apnea Archives - Medical Design Sourcing

ResMed CPAP masks recall is Class I

The AirTouch N20, one of the devices affected by the corrective action. [Image from ResMed]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 (NYSE: RMD) + 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 them if they’re contraindicated. ResMed instead instructed people using the masks to keep the magnets at least 6 in. away from implants or medical devices that could be affected — and to check with physicians and device makers about whether magnetic fields could negatively affect an implant.

ResMed also has an updated webpage with information about the potential problems.

More about the ResMed CPAP masks recall

In its announcement yesterday of the Class I des…

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 apiece. MassDevice‘s MedTech 100 Index was down slightly.

Inspire Medical Systems lost $8.5 million, or 29¢ per share, off of $153.3 million in revenue for the three months ended Sept. 30, 2023. Revenue was up 39% compared with Q3 2022. In addition, the company halved its losses compared to the same quarter last year.

Wall Street analysts had expected a loss of 58¢ per share and $154.45 million in revenue.

“Our growth continues to be driven primarily by higher utilization at existing sites and was complemented by the addition of 62 new …

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 are thrilled to announce this most impactful approval on World Down Syndrome Day,” Inspire Medical CEO Tim Herbert said in a news release.

“We acknowledge and appreciate the persistence of Dr. Hartnick’s team, as well as the teams at the many participating institutions, to collect the necessary clinical evidence to support the FDA approval. We would also like to thank the LuMind IDSC Down Syndrome Foundation for their support of our FDA application. Inspire intends to immediately begin educating healthcare providers across the U.S. about the benefits of Inspire therapy for children with Down syndrome.”

Bringing Inspire …

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 lost $14.5 million, or 53¢ per share, off $91.4 million in sales for the quarter ended June 30, 2022 — versus a loss of $13.1 million, or 48¢ per share, off $53 million in sales for the same quarter a year before.

The results handily beat the expectations of Wall Street analysts, who had expected a loss of 62¢ per share off $78.28 million in revenue.

“The Inspire team executed extremely well during the second quarter, continuing the rebound from the first quarter that was challenged by both COVID and our normal seasonality. Moreover, our strong second quarter performance overcame several challenges common across the medical technolog…