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.

From the Hospital Bed to the Finish Line

Heidi Dohse was diagnosed with a rare arrhythmia in 1982 and has been 100% pacemaker dependent for over 30 years. With the help of wearable devices, she has been able to pursue her dream to become a competitive cyclist.

You can hear her story and more when you register for DeviceTalks Boston, October 8-10.

REGISTER NOW

Use code FINISHLINE to save an additional 10%.

Freudenberg medical touts catheter handle platform and steerable introducers
Freudenberg Medical is touting its new catheter handle platform and its steerable introducer products. The Composer XL Deflectable Catheter Handle Platform gives users a commercialization-ready interface that is designed to give integrated control, according to the company. It is sized for large bore structural heart and endovascular devices like transcatheter tricuspid and mitral valve delivery […]
Livongo touts first connected BP monitor
Consumer digital health company Livongo Health today announced the first cellular-enabled blood pressure monitoring system in the U.S. Cellular connectivity allows for easy checking and reporting from home, eliminating the so-called “white coat” syndrome that leads to unnecessary prescriptions for high blood pressure, the company said in a prepared statement. Nearly 65% of people already […]
BMF Material Technology to use Onshape software for high-precision manufacturing
BMF Material Technology, a provider of micro/nano-scale 3D printing and precision manufacturing, has picked up Onshape’s 3D cloud CAD platform, the companies said today. Officials at BMF (Shenzhen City, China) think Cambridge, Mass.–based Onshape‘s real-time data management platform will enable them to speed up collaboration and communication with customers, helping them optimize their CAD models. Micro/nano-scale […]
Medtronic joins initiative to bring more women into the board room
Medtronic (NYSE:MDT) said today that it joined the Catalyst CEO Champions For Change initiative, pledging to add more women to its executive team and board of directors. The medtech titan teamed up with global nonprofit Catalyst and promised that it would “strengthen the pipeline of women” within the organization using annual reviews and data tracking. Get […]
Check-Cap receives Israel approval for C-Scan System
Check-Cap recently announced that it has received approval from the Israeli Ministry of Health Medical Device division (AMAR) to start marketing its C-Scan System. The C-Scan System is an ingestible capsules used for preparation-free colorectal cancer screening. The system received CE Mark approve in January this year. “We are excited to receive approval from the […]
Gore’s aneurysm device for tricky anatomies implanted in Europe
The first European patient with a challenging anatomy has had the Gore Excluder conformable abdominal aortic aneurysm (AAA) endoprosthesis implanted, according to W.L. Gore & Associates. The next-generation endovascular aneurysm repair (EVAR) device is indicated to treat the broadest range of abdominal aortic aneurysms in patients with difficult anatomies. They include patients with proximal aortic neck […]
FDA clears AMDT’s SixFix deformity correction software
AMDT Holdings recently announced that its SixFix deformity analysis and correction software and instrumentation. The SixFix system is indicated for use with Smith & Nephew’s Taylor Spatial Frame to reduce the time and effort that comes with manually inputing measurement and values that are required by currently available alternative. It also creates a prescription that […]
Theragenics, C4 Imaging ink sales and marketing deal for Orion MRI markers
Theragenics will provide sales and marketing for C4 Imaging‘s Orion Positive Signal HDR MRI Lumen Marker, according to a new deal the companies recently signed. “Orion, C4 Imaging’s Positive Signal HDR MRI Marker, which is based on the encapsulation of C4, our unique MRI agent, allows accurate positive-signal MRI treatment planning to be offered to […]
CoreLink Surgical wins FDA clearance for stand-alone anterior lumbar system
CoreLink Surgical announced that it has received FDA 510(k) clearance for its M3 Stand-Alone Anterior Lumbar (ALIF) System. “M3 is our first stand-alone inter body fusion device to feature 3D printing. I continue to be impressed by the ability of our design teams to rapidly turn direct feedback and market demand into commercially competitive products,” […]
The 10 largest medtech employers of 2018 – and what their employees really think
Among the 10 largest medtech employers, workers feel pride in working on life-saving products – but there’s also frustration with big corporate bureaucracy. That was the major takeaway as Medical Design & Outsourcing compiled some of the most insightful current and former employee reviews posted on Glassdoor. The 10 companies we’re counting down were the largest […]
How suppliers are taking drug-delivery tech to the next level
Medical device industry suppliers and outsourcers are helping to enable the latest drug-delivery tech. Drug-eluting technologies are moving beyond stents, thanks in part to the development of polymeric hydrogels engineered to respond to a range of different physical and chemical stimuli. Medtech innovators have figured out how to use hydrogels as components of micro-shells or […]