MedTech News

Forma Medical Granted FDA Clearance For Optimal Plating System Enabling a Multi-Faceted Growth Strategy for MIS Forefoot Portfolio
CAMP HILL, Pa.–(BUSINESS WIRE)–Forma Medical Inc., a leading innovator in medical device technologies, is thrilled to announce the FDA 510(k) clearance for its groundbreaking OptimalMTP® Plating System. This regulatory milestone marks a significant leap forward in MIS (Minimally Invasive Surgery), ushering in a new era of precision and efficiency dedicated to foot and ankle surgery, one of the fastest growing segments in the medical device space.

Implantable LED device uses light to treat deep-seated cancers
To bring light’s benefits to these harder-to-access cancers, engineers and scientists at the University of Notre Dame have devised a wireless LED device that can be implanted. This device, when combined with a light-sensitive dye, not only destroys cancer cells, but also mobilizes the immune system’s cancer-targeting response.

Roche receives CE Mark for its AI-enabled continuous glucose monitoring solution
Roche has announced that it has received the CE Mark for its Accu-Chek SmartGuide continuous glucose monitoring (CGM) solution. This significant milestone paves the way for the solution to be made available to people living with type 1 and type 2 diabetes over the age of 18 on flexible insulin therapy.

FDA clears Orthofix Fitbone transport and lengthening system
Orthofix (Nasdaq: OFIX) today announced it received FDA 510(k) clearance for the Fitbone Transport and Lengthening System and reported the first implant of the device.

Cordis wins FDA nod for vascular closure device
Cordis announced today that the FDA granted premarket approval (PMA) for its Mynx Control venous vascular closure device (VCD).

Scientists develop bandage that measures glucose levels in sweat using microlaser technology
Scientists from Nanyang Technological University, Singapore (NTU Singapore) have developed a band-aid or plaster that measures body biomarkers that can indicate health or disease through sweat, paving the way for a new non-invasive and effective way for patients to monitor their health.

Pulse Biosciences wins FDA breakthrough nod for AFib-treating pulsed field ablation tech
Pulse Biosciences (Nasdaq:PLSE) announced today that the FDA granted breakthrough device designation for its pulsed field ablation system. Shares of PLSE rose more than 20% in mid-morning trading on the back of this announcement.

New wearable patch measures trace perspiration during activity and rest
Researchers at University of Tsukuba have pioneered a state-of-the-art wearable device capable of precisely and continuously measuring trace perspiration amounts. This innovative device is adept at monitoring perspiration levels during not only physical activity but also rest. Its potential applications extend beyond monitoring dehydration caused by exercise or heat exposure, encompassing broader domains such as daily health management and disease detection.