Japan approves Inspire Medical’s obstructive sleep apnea neurostim device

June 29, 2018 By Fink Densford Leave a Comment

Inspire Medical Systems said this week it won approval from Japan’s Ministry of Health, Labour and Welfare for its Inspire therapy system, now cleared to treat moderate to severe obstructive sleep apnea.

The Inspire system is a closed-loop, pacemaker-like system designed to stimulate nerves to keep airways open during sleep to treat obstructive sleep apnea.

Inspire Medical Systems said that it will pursue reimbursement in the country, with plans to launch the device in the second half of next year.

“With this approval for our Inspire therapy, we are able to provide patients and physicians in Japan with a new alternative for the treatment of moderate to severe OSA. Our Inspire therapy is supported by a strong body of evidence with more than five years of clinical experience demonstrating the efficacy and safety of our therapy for patients and physicians. We look forward to commercializing our Inspire therapy in Japan. We would like to thank Cobridge Co., Ltd., a leading regulatory affairs consulting firm that provides comprehensive product registration services for medical products in Japan, for their outstanding efforts and expertise in assisting us to gain approval in Japan,” prez & CEO Tim Herbert said in a press release.

Last month, Inspire Medical Systems up-sized its initial public offering to $108 million, or some $124 million if the underwriters option is exercised in full.

Only a Few More Days to Register for the most anticipated conference of the winter!

DeviceTalks West is just a few days away. Join more than 300 of your peers for a day of world-class education, networking, and a technology exhibition featuring the leading companies in the industry.

Don’t miss out on this premier opportunity to come together and share perspectives with the best of the best in the industry.

REGISTER NOW

Use code LASTCHANCE to save an additional 20%.

Micromo launches miniature gearheads for linear actuation
Micromo has launched a new series of linear actuators that allow lead screws to be integrated into standard gearheads. The company suggests that the new miniature gearhead integration offers lower costs with space savings when compared to adding a conventional thrust module. Micromo’s new gearheads with integrated lead screws come in 6mm, 8mm and 10mm… […]
How Reggie Groves reinvented Medtronic’s atrial fibrillation biz
Reva Medical (ASX:RVA) CEO Reggie Groves got her start in the medical device industry at medtech titan Medtronic. In her upcoming keynote interview at DeviceTalks West, Groves will discuss how that experience has shaped her as a leader and an innovator. Here’s a preview: When Reggie Groves joined Medtronic (NYSE:MDT) in 2002, she didn’t know very much about… […]
Bruin Biometrics lands second SBIR award for ortho device
Bruin Biometrics (BBI) said it has won a $1.4 million Small Business Innovation Research (SBIR) Phase II program award from The National Institute of Arthritis and the musculoskeletal and skin division of the National Institutes of Health. BBI (Los Angeles) uses biometric sensor technology to aid clinicians in the early detection and monitoring of chronic,… […]
What is the future of medtech in 2019?
A global push to increase medical device industry regulation and the continued blurring of high tech and medtech – those are but some of the predictions that Medical Design & Outsourcing editors are hearing from experts. Read on to discover some of the top predictions of where the industry is going in 2019. Next>> Senior… […]
Vapotherm touts automated oxygen controller in preemie study
A recent clinical trial showed that Vapotherm’s (NYSE: VAPO) new IntellO2 module for its Precision Flow system greatly improved the chances of keeping premature babies in the target oxygenation range. The prospective, multi-center, controlled, order-randomized crossover trial demonstrated that using the IntellO2 module helped clinicians maintain newborns in the physician-prescribed oxygen saturation range 80% of the time, compared… […]
OKW offers new wall mounting kit for Evotec Enclosures
OKW has launched a new suspended wall mounting kit for its Evotec table-top enclosures. The new wall kit allows the Evotec to be used for access control, measurement and control engineering, IT, medical, laboratory and environmental technology. OKW suggests that the new suspension element could be used for any small plastic enclosure with a flat… […]
How data analytics can give medtech companies a competitive edge
There’s a whole spectrum of analytics techniques available to medtech leaders, and while innovations like automated personal assistants are great, it’s the middle of the spectrum where the greatest value is created, and from which companies can derive a competitive advantage. Maria Kliatchko, ZS Associates When we think of advanced analytics, we think of AI… […]
KNF touts new compact high-flow gas pump
KNF has launched its new micro gas pump, the NMP830 HP for its OEM customers. The diaphragm pump offers high flow, pressure and suction in its compact size, making it ideal for medical therapy, monitoring and reprographic applications. NMP830 HP measure 31mm in width and produces free flow up to 5.5 L/min using a single… […]
In2Bones launches CoLink View plating device
In2Bones recently launched its CoLink Afx Ankle Fracture System in the U.S. The system consists of five plate families that are designed to address traumatic fractures and osteotomies of the ankle. Plate options include Lateral Fibula, Posterior-Lateral Fibula, One-Third Tubular, Medial Tibia and Posterior Tibia. The plates also come with 2.7 and 3.5mm cortical screws… […]
Datix courts medtech industry with software solutions
Enterprise software consulting firm Datix has begun moving into the medtech arena. The St. Louis company, which has served a range of midsize manufacturers and distributors for more than 20 years, said it recently gained growing interest from medical device manufacturers in need of comprehensive enterprise resource planning (ERP) solutions. “Managing medical device manufacturing operations… […]
One-year-old Midwest Interventional Systems set to expand
Midwest Interventional Systems (MIS) is planning an expansion one year after beginning operations at its R&D and manufacturing facility in Fridley, Minn. The expansion will include the addition of quality, regulatory, operations, fulfillment, and distribution services. MIS also plans to expand on its existing extrusion, laser welding, laser cutting, and packaging capabilities. The company will… […]