Spark Biomedical announced today that the FDA granted breakthrough device designation to its transcutaneous electrical nerve stimulator designed to reduce signs and symptoms of neonatal opioid withdrawal syndrome (NOWS). NOWS results from exposure to prescription or non-prescription opioids such as methadone or heroin during pregnancy. Currently, no nationwide standard of care exists for managing NOWS, although […]
Bioelectronic Medicine
CarThera collects $14.3M
CarThera announced today that it received a $2.3 million (€2 million) grant and $12 million (€10.5 million) in equity, totaling $14.3 million. Paris-based CarThera was selected by the EIC Accelerator Pilot to receive the funds as it develops its Domeus project for treating glioblastoma patients. In addition to the money, CarThera is also slated to […]
Boston Scientific launches Vercise Genus DBS system in Europe
Boston Scientific (NYSE:BSX) announced that it received CE Mark for its fourth-generation Vercise Genus deep brian stimulation system. Vercise Genus includes full-body MRI conditional and Bluetooth capabilities within a DBS system designed for treating the symptoms of Parkinson’s disease, essential tremor and dystonia by delivering electrical stimulation to targeted parts of the brain. Marlborough, Mass.-based Boston […]
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 […]
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 […]
CVRx reports positive six-month trial results for Barostim Neo
CVRx announced today that it observed positive six-month results from its BeAT-HF trial for the Barostim Neo device for improving symptoms of heart failure. Barostim Neo uses patented technology to send electrical pulses to baroreceptors in the wall of the carotid artery in an effort to restore balance to the automatic nervous system and improve […]
Masimo announces drug-free opioid-withdrawal device
Masimo (NSDQ:MASI) announced that it received FDA de novo classification for its Bridge neuromodulation-based opioid withdrawal device. Bridge uses neuromodulation to aid in reducing the symptoms associated with opioid withdrawal. Irvine, Calif.-based Masimo touts it as the first evidence-based, drug-free, non-surgical device of its kind. The wearable, single-patient-use, percutaneous neurostimulator fits behind the ear and applies […]