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.
Exact Sciences Corp. reported performance data for its blood-based colorectal cancer screening test that showed sensitivities of 88.3% for CRC and 31.2% for advanced precancerous lesions at specificity of 90.1% for negative samples confirmed by colonoscopy.
Researchers at Klick Labs Inc. reported using a person’s voice to predict chronic hypertension with a high degree of accuracy. Data published in IEEE Access, found the potential for advancing early detection of chronic high blood pressure, showcasing another novel way to harness vocal biomarkers for better health outcomes.
Insulet Corp.’s Omnipod 5 automated insulin delivery system has been cleared by the US FDA for the indication of type 2 diabetes, making it the first automated insulin delivery system cleared for both type 1 and type 2 diabetes management.
Vericel Corp.’s Maci for repairing cartilage defects in the knee has been approved by the U.S. FDA via a supplemental biologics license application. Using a patient’s own cells cultured on a porcine collagen membrane, Maci Arthro is delivered arthroscopically and allows for repair of knee cartilage defects up to 4 cm2.
A new brain-computer interface (BCI) developed at UC Davis Health is able to translate brain signals into speech with up to 97% accuracy – the most accurate system of its kind.
