Merit Medical Systems Inc. received an early holiday gift this year, reporting that its Wrapsody cell-impermeable endoprosthesis has received premarket approval from the U.S. FDA and plans to begin commercialization of the device there in 2025.
At its investor day conference, Edwards Lifesciences Corp. prognosticated that an expanded indication in transcatheter aortic valve replacement and rapid growth in its newer mitral and tricuspid heart valve technologies will accelerate total company sales in 2026 and beyond.
Zap Surgical Systems Inc. reported closing a $78 million series E funding round led by Qingdao Baheal Medical Inc., with participation from other strategic investors. The new funds will be used to commercialize the company’s Zap-X gyroscopic radiosurgery platform for the non-invasive treatment of brain tumors.
A major increase in the popularity of weight loss drugs, particularly GLP-1s, has created a rivalry with traditional device orientated approaches, but a new technology aims to navigate the space between them.
Baxter International Inc., whose North Cove manufacturing site in Marion, North Carolina, was significantly impacted by the rain and storm surge from Hurricane Helene – including flooding of the facility – in September, reported that restoring the physical facilities has exceeded its expectations, with meaningful advances in site cleanup and remediation.
Borvo Medical Inc., a neurointerventional med-tech startup, reported U.S. FDA 510(k) clearance of its Endoport Vacuum Assisted Collection (EVAC) system, an alternative to traditional subdural hematoma (SDH) drainage methods. The EVAC system is expected to be available in early 2025 the company said.
Abbott Laboratories reported it achieved new major milestones to support the company's growing suite of pulsed field ablation (PFA) solutions in electrophysiology: early completion of enrollment in the VOLT-AF IDE study supporting the Volt PFA system, and the launch of the Focalflex trial to assess the company's Tactiflex Duo ablation catheter, sensor enabled, which will be used in the treatment of patients with paroxysmal atrial fibrillation.
Medtronic plc reported a voluntary recall of certain insulin pumps after customers said a single drop, bump, or physical impact could shorten their battery life.
Merit Medical Systems Inc. reported it is buying the lead management assets of Cook Medical Inc. for $210 million in cash. The Cook products consist of lead extraction devices and other lead management products.
