Wednesday, 24 September 2025

Medical Devices

Nesa Medtech gets US FDA clearance for fibroid mapping reviewer application

Novel SaMD technology generates a 3D model of uterus to facilitate treatment in patients with symptomatic uterine fibroids...

BD Receives FDA 510(k) Clearance for Updated BD Alaris™ Infusion System

BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, announced that the updated BD Alaris™ Infusion System has received 510(k) clearance from the U.S. Food and Drug Administration (FDA), which enables both remediation and a return to full commercial operations for the most comprehensive infusion system available in the United States....

Unrivalled Precision of 12-Lead ECG

As individuals, we must make informed decisions and prioritise the use of 12-lead ECG devices for prevention and monitoring purposes...

UroMems Announces First-Ever Smart Artificial Urinary Sphincter Implant in a Female Patient

Initial clinical study results will inform pivotal clinical trial in U.S. and Europe...

Aevice Health's Smart Wearable Stethoscope Receives US FDA Clearance for Remote Respiratory Monitoring Platform

Aevice Health, a leading provider of remote respiratory monitoring solutions for the healthcare continuum and backed by the Cedars-Sinai Accelerator, announced that its flagship medical device, the AeviceMD, has received clearance from the U.S. Food and Drug Administration (FDA) as a Class II medical device under the 510(k) route....

Vial Enrolls First Patient in "OcuCool" Precision Cooling Trial Sponsored by RecensMedical

Vial, a leading global contract research organization (CRO) providing next-generation clinical trial management services, announced the enrollment of the first patient in the pivotal clinical trial, "COOL-3s", evaluating the OcuCool system, developed by RecensMedical, Inc. ("RecensMedical"), a distinguished medical device company based in South Korea. ...

FDA Clears ReddyPort® Non-Invasive Ventilation Device

ReddyPort announced that the US Food and Drug Administration (FDA) granted 510(k) premarket clearance for the ReddyPort elbow device used in non-invasive ventilation (NIV)....

Mylab launches MyBox+ device with proprietary Dry Luminescence Immunoassay technology

Marks a departure from traditional liquid reagent-based testing methods...