Theranica announced today that it received CE Mark approval for its Nerivio device for the acute treatment of migraine. Montclair, N.J.-based Theranica adds European approval just over a year since it received FDA de novo clearance for the neurostimulation device in May 2019. The approval allows for the company to begin marketing the device in […]
Neuromodulation/Neurostimulation
UK recommends Axonics SNM for overactive bladder
Axonics Modulation Technologies (NSDQ:AXNX) announced today that NICE suggested using its r-SNM system in the UK. The National Institute for Health and Care Excellence (NICE) offers evidence-based guidance to the UK and, in guidance published last week, it recommended Axonics’ sacral neuromodulation (SNM) system for treating refractory overactive bladder for the country’s National Health Service (NHS). […]
The top 5 MassDevice stories of the week — September 4, 2020
Medtronic (NYSE:MDT) and a major development involving medtech reimbursement dominated medical device industry news over the past week. As the week closes out, there’s also a trending story on MassDevice that includes good news: Abbott (NYSE:ABT) is reportedly hiring 2,000 new employees in Illinois to increase manufacturing for its rapid COVID-19 test. Want to hear more about […]
Elon Musk’s Neuralink moving forward with brain implant
Elon Musk is touting his Neuralink venture’s “Link” deep brain stimulator implant as a less invasive deep brain stimulation system — disclosing new details about the device. Neuralink had previously only described its technology in broad strokes, as “ultra-high-bandwidth brain-machine interfaces to connect humans and computers.” During a press conference last year, Musk and company […]
NeuroPace raises $67M for RNS system
NeuroPace announced today that it raised $67 million for its RNS system for treating refractory focal epilepsy. Accelmed Partners led the round, while an unnamed strategic investor, Revelation Partners, Soleus Capital and returning investors KCK Group and OrbiMed Advisors also participated, according to a news release. Mountain View, Calif-based NeuroPace’s financing includes $33 million in […]
DTW Podcast: Truist’s Kaila Krum says Medtronic prepping for growth
In an interview with DeviceTalks Weekly Podcast, Truist Securities managing director Kaila Krum says Medtronic executives are retooling the company to keep pace with smaller, more focused competitors. Breaking down the company’s Q1 call, Krum says Medtronic is seen as a company that’s too big to grow market share quickly. On the call, new CEO […]
DTW Podcast: Can Fractyl Labs and Cala Health go where only drugs have gone before?
In this week’s DeviceTalks Weekly podcast, co-costs Tom Salemi and Chris Newmarker walk through this week’s “Newmarker’s Newsmakers,” the Top Five #medtech stories of the week with news coming from CureVac, Avail Medsystems, ClearMask, Thermo Fisher and Bayer. We also hear from CEO Harith Rajagopalan, MD and CFO Lisa Davidson of Fractyl Laboratories, which is […]
Cala cites positive data in Trio tremor trial
Bioelectronic company Cala Health released positive data from its ongoing PROSPECT trial demonstrating that a majority of patients using its FDA-cleared Cala Trio device reported a reduction in hand tremors. The study — published in Tremor and Other Hyperkinetic Movements — enrolled 263 patients with essential tremor across 26 sites. Patients wore the Trio on […]
MagVenture wins FDA clearance for OCD TMS treatment device
MagVenture announced that it received FDA clearance for its TMS Therapy for adjunct treatment of obsessive-compulsive disorder (OCD). Alpharetta-Ga.-based MagVenture said in a news release that the authorization is its second from the FDA, having already been cleared for its treatment of major depressive disorder. TMS Therapy uses magnetic pulses to stimulate a specific area […]
Neurolief wins FDA breakthrough nod for wearable neuromod for depression
Neurolief announced today that it received FDA breakthrough device designation for its Relivion DP system for treating major depression. Relivion is a wearable, non-invasive, multi-channel brain neuromodulation device designed as an adjunctive treatment to pharmaceutical management of major depressive disorder (MDD) in adults who haven’t experienced satisfactory improvement from antidepressant medications, according to a news […]
Axonics beats on Q2 earnings despite losses
Axonics Modulation Technologies (NSDQ:AXNX) shares dipped slightly today on second-quarter results that beat the consensus earnings forecast. The Irvine, Calif.-based sacral neuromodulation (SNM) device maker posted losses of -$19.8 million, or -54¢ per share, on sales of $15.1 million for the three months ended June 30, 2020, for a -3.8% bottom-line slide on massive sales growth […]