de novo clearance

Essilor Luxottica Stellest expo booth
MedTech

FDA clears 1st eyeglasses for slowing childhood nearsightedness

The FDA handed a groundbreaking clearance to EssilorLuxottica and its eyeglasses to help slow the progression of nearsightedness in young children.
Conor Hale 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
colorful brain art model

FDA clears prescription migraine app from Click Therapeutics

Apr 17, 2025 11:35am
NICU

FDA clears vibrating pad to nudge breathing in preterm newborns

Apr 8, 2025 11:00am