Transparent, well-designed clinical trials are a must. Here’s advice on how to get there. Scott Nelson, co-founder and CEO of FastWave Medical Dozens of medical devices annually make it onto the FDA’s list of the newest approved medtech. Yet, alongside this progress, the agency faces a stark reality: over the last decade, faulty devices have been […]
Mainstay Medical
The largest medtech funding rounds of 2024
Over the past 12 months, a number of medtech companies at various stages hauled in significant funding rounds to support their innovations. Technologies that were supported by hundreds of millions of dollars in 2024 included pulsed-field ablation, brain-computer interfaces (BCIs), AI-enabled surgical software and more. In all, the amount of medtech companies receiving more than […]
Mainstay Medical raises $125M for neurostim tech
Mainstay Medical announced an equity financing worth $125 million set to support the commercial growth of its neurostimulation technology. The company plans to put its new funds toward commercializing its ReActiv8 system in the U.S., Europe and Australia. It also has eyes on using the money for post-market clinical studies and research, plus general operations. […]
FDA approves MRI labeling on Mainstay Medical’s ReActiv8 restorative neurostimulation system
Mainstay Medical this week announced it received FDA approval for MRI labeling on its ReActiv8 restorative neurostimulation system. The approval allows patients implanted with the 45 cm ReActiv8 leads to be eligible for full-body MRI scans. Patients will be able to undergo 1.5T full-body MRI scans. Specific scan conditions and safety information are provided in […]
Mainstay Medical launches implantable neurostim system in U.S.
Mainstay Medical today announced the limited commercial launch of its ReActiv8 implantable restorative neurostimulation system in the U.S. The Ireland-based company designed ReActiv8 to treat intractable chronic lower back pain. The system will be available in the U.S. through ReActiv8-certified physicians this summer. “Supported by more than 10 years of clinical research, ReActiv8 is the […]
MedTech 100 roundup: Slight dip after all-time best for industry
The medtech industry’s stocks rose higher than they ever had to begin last week before eventually dropping to a slightly more normal level. MassDevice‘s MedTech 100 index ended the week (Feb. 19) at 108.72 points, marking a -1.7% dip from the 110.63-point mark set at the end of the previous week (Feb. 12). On Monday (Feb. […]
DTW Podcast – Tale of Two CEOs – How Tim Herbert led Inspire to an IPO; Where Rob Bodor wants to take Protolabs
Inspire Medical CEO Tim Herbert never set out to be a CEO. Yet, he spun a promising sleep apnea technology out of Medtronic. He then assembled a team that helps hard-to-treat apnea patients live healthier lives through better sleep. Oh, and the electrical-engineer-turned-startup-CEO took the medtech public in 2018. Listen to this episode to hear […]
Mainstay Medical raises $108M
Neurostimulation technology developer Mainstay Medical announced that it closed an equity financing worth gross proceeds of $108 million. Dublin, Ireland-based Mainstay said in a news release that it plans to use the funds for the commercial launch of the ReActiv8 system in the U.S., along with continued expansion in Europe and Australia, plus post-market clinical […]
FDA approves Mainstay Medical neurostim device
Mainstay Medical announced that it received FDA premarket approval for its ReActiv8 implantable neurostimulation system for chronic low back pain. ReActiv8 treats intractable chronic low back pain associated with multifidus muscle dysfunction, as evidenced by imaging or physiological testing in adults who have failed therapy and are not candidates for spine surgery, according to a […]
Smith & Nephew CEO Bohuon to retire | Personnel Moves – Oct. 10, 2017
Smith & Nephew (NYSE:SNN) said today that its current CEO Olivier Bohuon has announced his intention to retire by the end of 2018 and that the company has begun a search for a new chief exec. Bohuon joined the company in 2011, and has overseen a significant rise in share value with the company since taking the […]
Mainstay Medical taps ex-NuVasive COO Hannon for CEO | Personnel Moves, Sept. 7, 2017
Mainstay Medical (EPA:MSTY) said this week that it tapped former NuVasive Inc. (NSDQ:NUVA) president & COO Jason Hannon to succeed Peter Crosby as CEO, effective Oct. 9. Crosby, recruited in 2009 to lead the company and its development of the Reactiv8 neurostimulation device for treating chronic pain, is slated to act as a consultant for Mainstay through […]
