MedTech News
Abbott wins FDA clearance for its Lingo OTC glucose monitor
Abbott (NYSE: ABT)+ has secured a 510(k) clearance from the FDA for its over-the-counter Lingo glucose-monitoring biowearable.
Enable Biosciences Secures Patent for Antibody Detection Method with Applications in Type 1 Diabetes
SOUTH SAN FRANCISCO, Calif., May 30, 2024 /PRNewswire/ — Enable Biosciences Inc. has been awarded a patent for a cutting-edge method of detecting polyclonal antibodies, marking a significant advancement in diagnostic technologies, particularly in assessing the risk of Type 1 Diabetes (T1D).
TOOsonix receives MDR CE Mark for its new oncology and dermatology device
The EU Medical Device Regulation CE certification approves that the most common types of skin cancer and a wide range of skin diseases and conditions can be treated in less than 90 seconds.
Spineart wins FDA clearance for Scarlet AC-Ti anterior cervical cage
Spineart recently announced it received FDA 510(k) clearance for its Scarlet AC-Ti secured anterior cervical cage.
Terumo wins FDA 510(k) for next-gen bypass surgery monitoring
Terumo Cardiovascular today announced FDA 510(k) clearance of its next-generation CDI OneView monitoring system.
Comar Achieves CE Certification for Medical Devices Under New EU MDR Regulations
BUENA, N.J., May 29, 2024 /PRNewswire/ — COMAR, a leading provider of innovative medical devices and packaging solutions, is thrilled to announce a significant achievement. After rigorous preparation, they successfully obtained their CE certificate under the latest EU Medical Device Regulations (EU MDR 2017/745).
Indica Labs receives first FDA clearance for HALO AP Dx digital pathology platform
HALO AP Dx brings digital primary diagnosis to anatomic pathology labs in the US.
Canary Medical wins FDA breakthrough nod for smart spine tech
Canary Medical announced today that it received FDA breakthrough device designation for its Canturio lumbar cartridge.