de novo clearance

Woman choking and coughing
MedTech

FDA greenlights backup anti-choking suction device

With a plungerlike handle and an air mask placed over the nose and mouth, the LifeVac is designed for adults and children at least 1 year old.
Conor Hale Mar 9, 2026 10:45am
Biolinq wearable on inside forearm

FDA clears Biolinq's color-coded sensor patch for glucose ranges

Sep 29, 2025 11:30am
Essilor Luxottica Stellest expo booth

FDA clears 1st eyeglasses for slowing childhood nearsightedness

Sep 26, 2025 11:38am
An artists illustration of a neuron with electrical pulses used here to illustrate nerve conduction in neuropathy

Tissium snags FDA de novo clearance for sutureless nerve repair

Jun 24, 2025 11:45am
FDA

FDA clears Reflow Medical’s retrievable below-the-knee stent

Jun 9, 2025 11:00am
oncology cancer test mammogram mammography breast cancer

FDA clears Clairity's 5-year breast cancer risk prediction tool

Jun 5, 2025 1:00pm