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 […]
Neuromodulation/Neurostimulation
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 […]
Medtronic launches InterStim neurostim leads in U.S.
Medtronic (NYSE:MDT) today said it has launched its InterStim Micro neurostimulator in the U.S. The sacral neuromodulation therapy was FDA approved earlier this week and received CE mark approval in January. InterStim Micro is a neurostimulator that sends electrical impulses to the sacral nerves in the lower back to improve bladder and bowel control. The therapy […]
Neuronetics rises on Street-beating Q2
Neuronetics (NSDQ:STIM) shares ticked up today on second-quarter losses that managed to top the consensus forecast. The Malvern, Pa.-based psychiatric disorder treatment developer posted losses of $-7.8 million, or -41¢ per share, on sales of $9.7 million for the three months ended June 30, 2020, for a -9.5% bottom-line slide on a sales decline of -41.2%. […]
FDA approves new Medtronic neurostim leads
Medtronic (NYSE:MDT) announced today that it received FDA approval for its InterStim Micro neurostimulator and SureScan MRI leads. Fridley, Minn.-based Medtronic’s InterStim Micro device for delivering sacral neuromodulation (SNM) therapy is used in treating overactive bladder, fecal incontinence and non-obstructive urinary retention. According to a news release, it is the smallest rechargeable device of its kind. […]
LivaNova slides despite forecast-topping Q2 results
LivaNova (NSDQ:LIVN) shares dipped today despite second-quarter results that beat the consensus forecast. The London-based medtech company posted losses of -$88 million, or -$1.81 per share, on sales of $182.2 million for the three months ended June 30, 2020, for a massive bottom-line slide from losses of $29.2 million this time last year on a sales […]
DTWeekly Podcast: Can Drawbridge, Edwards bring disruptive innovation to blood drawing, heart surgery industries?
In this week’s podcast, we talk with Holly Logue, general counsel at Drawbridge Health, about the OneDraw, an innovative new tool that might upend the collecting, storage and testing of blood. Logue, a panelist in the upcoming DeviceTalks Tuesdays sponsored by Finnegan, will explain how her past work on Capitol Hill is helping this Silicon […]
The 18 most innovative medical devices of 2020
The Galien Foundation recently announced nominees for most innovative medical devices for its 14th Annual Prix Galien USA Awards. The foundation bestows the Prix Galien Award annually to examples of outstanding biomedical and technology products that are designed to improve the human condition. “As we celebrate 50 years of the Prix Galien process, we are honored […]
People can now control their Abbott neuromod device over their iPhone
Abbott (NYSE:ABT) announced today that it received FDA approval for the use of its Patient Controller app on compatible Apple smartphone devices. The company’s Patient Controller app offers management tools for patients with implanted neuromodulation devices to treat conditions such as chronic pain or movement disorders. Now, with the latest approval from the FDA, it’s possible […]