MedTech News

InnoVoyce Achieves ISO 13485 Certification, Announces Nationwide Availability of VYLO™ Blue Light Laser System
BOSTON, Feb. 11, 2025 /PRNewswire/ — InnoVoyce, a leading medical technology company, proudly announces its ISO 13485:2016 certification, underscoring its dedication to excellence in the design, manufacturing, installation, and servicing of lasers and fiber devices. Alongside this milestone, the company is thrilled to share that its FDA-cleared VYLO™ 455nm Blue Light Laser System is now available nationwide, offering healthcare professionals an advanced tool for treating laryngeal disorders and a wide range of surgical applications.

Inspire Medical reveals DOJ civil investigation
CEO Tim Herbert told investors the company received a civil investigative demand from the Department of Justice in January for information on marketing and reimbursement practices.

Minimally invasive treatment could offer quick cure for common cause of high blood pressure
Doctors at Queen Mary University of London, Barts Health NHS Trust, and University College London have led the development of a simple, minimally invasive Targeted Thermal Therapy (Triple T) that has the potential to transform medical management of a common, but commonly overlooked, cause of high blood pressure.

Can deep learning transform heart failure prevention?
A deep neural network called CHAIS may soon replace invasive procedures like catheterization as the new gold standard for monitoring heart health.

Newronika wins FDA IDE for adaptive deep brain stim tech
Newronika announced today that it received FDA investigational device exemption (IDE) for its deep brain stimulation (DBS) system.

3D bioprinting technology could lead to personalized gastric cancer treatment
A collaborative research team from POSTECH has successfully developed a gastric cancer model using 3D bioprinting technology and patient-derived cancer tissue fragments. This innovative model preserves the characteristics of actual patient tissues and is expected to rapidly evaluate and predict individual patient drug responses. The research has been published in the journal Advanced Science.

Senseonics submits year-long CGM for CE mark
Senseonics (NYSE:SENS) announced today that it filed for CE mark for its Eversense 365 continuous glucose monitor (CGM) system.

Sibel Health’s AI-powered wearable reduces nighttime scratching in itchy patients
CHICAGO, Feb. 6, 2025 /PRNewswire/ — Sibel Health, an award-winning medical technology company that develops advanced wearable sensors, software, and AI/ML algorithms for clinical trials and clinical care, is pleased to announce a major peer-reviewed publication, “Artificial Intelligence-Enabled Wearable Devices and Nocturnal Scratching in Mild Atopic Dermatitis,” in JAMA Dermatology. This research describes a groundbreaking digital health technology designed to measure and reduce nighttime scratching in people with mild atopic dermatitis.