Precision Neuroscience announced that it launched new clinical study sites at Mount Sinai Health System and the University of Pennsylvania. The company says the studies represent “a major step forward” as it aims to understand how the brain controls movement. It hopes to utilize the sites to advance its brain-computer interface (BCI) technology for people […]
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Abbott wins CE mark for insertable cardiac monitor
Abbott announced today that it received CE mark approval for its Assert-IQ insertable cardiac monitor (ICM). The ICM provides a new option for diagnostic evaluation and long-term monitoring in people experiencing abnormal heartbeats. It can detect hard-to-spot irregularities in heartbeats and help physicians determine the best treatment course. Assert-IQ received FDA clearance in May 2023, […]
FDA clears Neuronetics’ neurostim for adolescents with depression
Neuronetics (Nasdaq:STIM) announced today that it received FDA clearance for the use of its NeuroStar therapy for adolescent patients. Clearance covers the use of NeuroStar as an adjunct treatment of major depressive disorder (MDD) in adolescent patients aged 15-21. Neuronetics said clearance makes NeuroStar the first and only transcranial magnetic stimulation (TMS) treatment cleared for […]
Axonics stockholders approve Boston Scientific acquisition
Axonics (Nasdaq:AXNX) announced that its stockholders voted to adopt its $3.7 billion merger agreement with Boston Scientific . Boston Scientific announced its intent to buy Axonics on Jan. 8. Irvine, California-based Axonics develops neuromodulation systems for treating urinary and bowel dysfunction. Its fourth-generation R20 rechargeable sacral neuromodulation (SNM) system received FDA approval around a year ago. […]
J&J’s Biosense Webster submits Varipulse pulsed field ablation system for FDA approval
Johnson & Johnson MedTech’s Biosense Webster announced today that it submitted its Varipulse platform to the FDA for premarket approval. The company supported its PMA submission for the pulsed field ablation (PFA) system with results from the admIRE study. It aims to garner approval for the treatment of paroxysmal AFib. If approved, Varipulse would become […]
Masimo looks to separate consumer business two years after $1 billion buyout
Masimo will move forward with a proposal by Chairman and CEO Joe Kiani to separate the medtech developer from its consumer business. Kiani would remain chair and CEO of Irvine, California–based Masimo and serve as chair of the new consumer company, which includes Sound United parent company Viper Holdings that Masimo bought for $1.025 billion […]
Former Neuropace CEO takes the helm at Revamp Medical
Revamp Medical this week announced it appointed Mike Favet as CEO, effective immediately. Favet joins the Netanya, Israel–based heart failure congestion management company with more than 20 years of executive-level experience. He most recently was CEO of Neuropace, where he led a commercial expansion and took the company public in 2021. “Mike brings a distinguished […]
Biotronik wins breakthrough nod for Freesolve BTK resorbable magnesium scaffold
Biotronik this week announced it received FDA breakthrough device designation for its Freesolve below-the-knee resorbable magnesium scaffold (BTK RMS). The Berlin, Germany-based cardiac rhythm company designed Freesolve for individuals suffering from chronic limb-threatening ischemia (CLTI). The newly launched device is not coronary artery lesions. “This breakthrough device designation for the Freesolve RMS for BTK treatment […]
Bessel launches accelerator program for medtech startups
Bessel and an Alabama tech hub today said they are launching Hatch Powered by Bessel, an accelerator program for medtech startups. Applications are now open for the 10-week program, which starts in Fairhope, Alabama, this summer. The accelerator “combines the passion of startup founders, the guidance of seasoned medical device experts, and the burgeoning startup […]
PTAB upholds two Medtronic patents in spat with Axonics, could go to jury trial
Medtronic announced today that the U.S. Patent and Trademark Office upheld many of its claims around two of its patents in its battle with Axonics (Nasdaq:AXNX). The office’s Patent Trial and Appeal Board (PTAB) affirmed the validity of many of the claims in two of Medtronic’s patents in the latest development in a long-running spat […]
FDA adds SetPoint Medical and its multiple sclerosis-treating neuromod to advisory program
SetPoint Medical announced today that the FDA accepted it into the Total Product Life Cycle Advisory Program (TAP) pilot. TAP provides early and frequent strategic engagement from the FDA, patients, providers and payers. It facilitates rapid development and widespread access to medical devices. Acceptance requires breakthrough device designation, which SetPoint Medical garnered last week. With […]