Cortex announced today that it began its RESOLVE-AF trial evaluating its Ablamap system with the newly released Ablacath mapping technology. Launched by Ajax Health in December 2023, the company already offers the FDA-cleared Ablamap with electrographic flow (EGF). It seeks to pair the system with the newly released Ablacath mapping catheter to identify extra-pulmonary vein […]
Catheters
FDA approves Farapulse pulsed field ablation tech from Boston Scientific
Boston Scientific announced today that it received FDA approval for its Farapulse pulsed field ablation (PFA) system. Shares of BSX were up more than 2% at $62.79 in morning trading on the back of the news, as the company also posted strong fourth-quarter earnings results. MassDevice‘s MedTech 100 Index was up nearly 1%. The much-anticipated […]
Microbot Medical settles investors’ lawsuit for more than $2M
Microbot Medical (Nasdaq: MBOT), the developer of the Liberty endovascular robotic surgical system, announced today that it has settled a years-old lawsuit involving a securities purchase agreement. Empery Asset Master, Empery Tax Efficient, Empery Tax Efficient II, and Hudson Bay Master Fund sued Microbot Medical in 2020 in the New York state court in New […]
Shockwave Medical looks to a digital health company for its next CFO
Shockwave Medical is tapping the CFO of smart stethoscope maker Eko Health as its next CFO. Renee Gaeta will succeed Dan Puckett, effective Feb. 5. Pucket, who has served as Shockwave Medical’s CFO since 2016, had previously announced his decision to retire. “Renee is a highly skilled and accomplished executive with a proven track record […]
Microbot Medical expands U.S. operations to prep for first in-human clinical study
Microbot Medical, the developer of the Liberty endovascular robotic surgical system, is building on the momentum from the positive results of its good laboratory practices (GLP) pre-clinical study. The company is adding a clinical research associate to support its pending investigational device exemption, or IDE, submission to commence its first-in-human clinical trial. The clinical research […]
Surmodics has positive early results from thrombectomy system
Surmodics (Nasdaq:SRDX) today announced the successful early clinical use of its Pounce LP thrombectomy system. Eden Prairie, Minnesota-based Surmodics designed the LP (low-profile) thrombectomy system for the non-surgical removal of thrombi and emboli from the peripheral arterial vasculature. It performs this removal in vessels between 3.5 mm and 6 mm in diameter. It introduced the […]
Abbott announces first procedures with Volt pulsed field ablation system
Abbott today announced the first global procedures conducted with its new Volt pulsed field ablation system. Volt treats patients battling common abnormal heart rhythms like AFib. It marks Abbott’s entry into the crowded pulsed field ablation (PFA) space alongside companies like Medtronic, Boston Scientific and Johnson & Johnson’s Biosense Webster. Last month, Medtronic became the […]
FastWave Medical kicks off first-in-human study of its IVL tech
FastWave Medical announced the successful completion of enrollment for its first-in-human study of its peripheral intravascular lithotripsy (IVL) system to treat calcified cardiovascular disease. Dr. Miguel Montero-Baker of Houston Methodist Hospital and the Hope Vascular & Podiatry Clinic and Dr. Venkatesh Ramaiah of HonorHealth Vascular Group and the Pulse Cardiovascular Institute successfully conducted the procedures […]
Autonomix completes preclinical transvascular ablation study to treat pancreatic cancer
Autonomix Medical announced today that it completed an animal safety study evaluating its proprietary ablation technology. The Woodlands, Texas-based company designed its tissue ablation technology to address pancreatic cancer-related pain. Current approaches, like opioids or ethanol injections, may only provide limited relief and may lead to risky side effects. The company hopes its proof-of-concept effort […]
Shockwave Medical plans for growth with 2-3 product launches each year
It was a busy 2023 for Shockwave Medical (Nasdaq:SWAV), with product launches, funding rounds and M&A at the heart of it. The company, which develops intravascular lithotripsy (IVL) technology, first made waves last year with its acquisition of Neovasc. Neovasc develops the Reducer system for addressing refractory angina. Shockwave remained in the middle of M&A […]
Biosense Webster wins Japanese approval for Varipulse pulsed field ablation
Johnson & Johnson MedTech’s Biosense Webster today announced Japanese approval for its Varipulse platform for treating AFib. Varipulse treats symptomatic drug-refractory recurrent paroxysmal AFib using pulsed field ablation (PFA). The platform features the Varipulse catheter, a variable-loop multielectrode catheter, the TruPulse generator and the Carto 3 3D cardiac mapping system. Biosense Webster says this marks […]