MedTech News
.................... by Andrew Celentano

FDA Grants Breakthrough Device Designation to TOBY Urine-Based Test for Alzheimer’s Disease
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the TOBY Alzheimer’s Test, a urine-based diagnostic test developed by TOBY, a biotechnology company based in Austin, Texas.

CSR secures certifications in EU and Singapore for Sentire system
The CE certification confirms compliance with regulatory standards for safety, efficacy, and quality management.

Neurovalens earns FDA nod for neuromod for PTSD
Neurovalens announced today that it received FDA de novo approval for Modius Spero, a post-traumatic stress disorder (PTSD) therapy.

AI-guided drug search flags folic acid for diabetic wound healing
Researchers from the National University of Singapore (NUS) have developed an AI-guided workflow that combines artificial intelligence (AI) with molecular simulations to identify potential drug candidates for diabetic wound healing, identifying folic acid, a common vitamin, as a top candidate.

An ‘intelligent tattoo’ to detect skin cancer before it appears
Detecting melanoma before it becomes visible is a major challenge in dermatology. Now, with researchers from Université de Montréal, scientists at Université du Québec’s Institut national de la recherche scientifique (INRS) have developed a promising solution.

Cornerstone Robotics wins CE mark for Sentire endoscopic surgical robot
Cornerstone Robotics announced today that it received CE mark approval for its Sentire endoscopic surgical robotic platform.

DNA repair protein gene gone rogue may unlock new cancer treatments
In a study published in Nature Communications, the researchers found that the EXO1 gene is overexpressed in 20% to 30% of breast and ovarian cancers as well as in melanoma, testicular, cervical, and hepatobiliary cancers, which develop in the liver, gall bladder, and bile duct

Thermoreversible biogel may solve a hairy problem for wearable brain-monitoring systems
Researchers at Penn State have developed a reusable material designed to solve both problems at once. The material is a thermoreversible semiconducting ionic biogel, meaning it becomes liquid when gently heated so it can move through hair and reach the scalp, then returns to a stable gel as it cools, keeping its conducting and semiconducting character.