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

Zepto Life Technology’s mould infection panel obtains FDA breakthrough designation
Zepto Life’s FungiFlex mould panel is designed to identify 14 clinically important mould species based on cell free fungal DNA detected in plasma.

Tandem wins CE mark for automated insulin delivery in type 2 diabetes, pregnancy
Tandem Diabetes Care (Nasdaq:TNDM) announced today that it received expanded CE mark for its automated insulin delivery (AID) systems.

Blood test spots 14 proteins that predict lung cancer risk up to five years early
Published today in Cell, the team applied machine learning to blood plasma protein data from more than 48,000 UK Biobank participants, using matched cancer registry records to identify those who later developed lung cancer.

AI decodes epilepsy signals in brain waves before seizures appear
University of Delaware researchers are using artificial intelligence to detect early warning signs hidden in the brain’s electrical rhythms.

Smartphone unlock can measure heart rate, potentially bringing health monitoring to billions worldwide
A recent study has found a way to track heart rate without requiring people to wear anything at all. Instead, all they need is for someone to use their smartphone, which is quite convenient, since the average person already spends upwards of five hours a day on their phone.

Topical gel helps burn wounds heal faster using an existing FDA-approved drug
Researchers at the Terasaki Institute for Biomedical Innovation and the University of Arizona College of Medicine have developed a topical gel formulation with 4-aminopyridine (4-AP), to treat burn wounds.

CeQur® Announces Exciting Advancements: 2 Recent FDA Clearances and New Clinical Evidence to be Presented at ADA
HORW, Switzerland, June 4, 2026 /PRNewswire/ — CeQur®, the company dedicated to simplifying mealtime insulin delivery for people living with diabetes, today announced two recent FDA clearances for CeQur Simplicity™: extended wear of up to seven days and a new 1-unit (1U) device.

OrthAlign Receives FDA 510(k) Clearance for Lantern ASC Navigation System for Ambulatory Surgery Centers
Irvine, CA-based OrthAlign has announced FDA 510(k) clearance for the Lantern ASC system, a handheld orthopedic navigation solution designed for ambulatory surgery centers. The system pairs a reusable navigation unit with a procedural Smart Pack Kit to deliver accurate, real-time navigation for total knee, partial knee, and gap balancing procedures in both primary and revision cases.