X-trodes Ltd. has received U.S. FDA 510(k) clearance for its Smart Skin solution, a wireless wearable technology that allows for medical-grade electrophysiological monitoring in clinics and at home. The company believes that the Smart Skin technology, which captures signals from the brain, heart, eyes and muscles, has the potential to significantly improve patient care.
Biosense Webster Inc. scored approval from Japan’s Ministry of Health Labour and Welfare’s (MHLW) for its Varipulse pulsed field ablation platform to treat symptomatic drug-refractory recurrent paroxysmal atrial fibrillation on Jan. 9., making it the first PFA system approved in the country.
The pivotal ADVENT trial of the Farapulse pulsed field ablation (PFA) system developed by Boston Scientific Corp. returned positive results at one year, according to a presentation at the ESC Congress 2023 that was simultaneously published in the New England Journal of Medicine. The study compared Farapulse, a nonthermal treatment that ablates heart tissue, to radiofrequency or cryoablation, the current standards of care for paroxysmal atrial fibrillation.
Johnson & Johnson’s Biosense Webster division reported that its Qdot Micro diagnostic and ablation deflectable tip catheter secured approval for marketing in China from the National Medical Products Administration where options for treating arrhythmias are seeing growing demand. A radiofrequency (RF) ablation catheter, Qdot Micro reduced total ablation procedure time by nearly 90 minutes.
Ra Medical Systems Inc. launched a simple device that holds sutures more securely in place for closure of percutaneous wound sites during cardiac electrophysiology, structural heart and vascular surgical procedures.
It’s a little early for St. Patrick’s Day, but the green is surely flowing for Acutus Medical Inc. as the company achieved its second milestone under the terms of its asset purchase agreement with Medtronic plc and triggered a $17 million payment.
Volta Medical SAS reported validation for its VX1 software mapping system, an artificial intelligence (AI) algorithm compatible with most commonly available multi-pole catheters and technology used in operating rooms and cath labs for treating cardiac arrhythmia. Results from the proof-of-concept-study were published in the Journal of Cardiovascular Electrophysiology.
Shanghai Microport Ep Medtech Co. Ltd. went public on the Shanghai Stock Exchange STAR Market and raised ¥1.17 billion (US$169.5 million) with its initial public offering. The company’s issue price was ¥16.51 per share. After opening at ¥15.50 per share, the share price dived to ¥13.15 at the closing of its first trading day. Microport Ep is an associated company of the Hong Kong-listed Microport Scientific Corp.
Sichuan Jinjiang Electronic Science and Technology Co. Ltd. (JJET) recently completed series A+ and series B rounds, raising a total of ¥700 million (US$101 million) in series A and series B financing.
Investors in Cathvision ApS are backing the company with an additional $7.2 million to accelerate U.S. commercialization of its electrophysiology (EP) recording system, Ecgenius. The ECG support technology is designed to detect cardiac electrograms with minimal baseline noise so electrophysiologists can accurately interpret complex arrhythmias, including atrial fibrillation (AF). In May, the U.S. FDA granted the Copenhagen-based company 510(k) clearance for the system.