Pantheon Vision has completed two pre-submission meetings with the US Food and Drug Administration (FDA) as the company looks to advance its corneal implants...
Lumicell today announced it received FDA approval for its LumiSystem direct visualization system for breast cancer removal.
According to the company, the LumiSystem allows surgeons...
Xstim announced today that it received premarket approval from the FDA for its Xstim spine fusion stimulator device.Irving, Texas-based Xstim designed its capacitively coupled...
Adherium has obtained US Food and Drug Administration (FDA) clearance for the use of its Hailie Smartinhaler with AstraZeneca’s Airsupra and Breztri inhalation devices.
This...
IceCure Medical announced it submitted final data to the FDA requesting marketing authorization for its ProSense system. Caesarea, Israel-based IceCure designed ProSense to deliver...
Onkos Surgical, an orthopaedic company founded to address the complex clinical challenges associated with bone loss due to tumor, trauma, and revision surgery, announced that...
DEKA Research & Development has received 510(k) clearance from the US Food and Drug Administration (FDA) for the twiist automated insulin delivery (AID) system.
The...
The FDA has cleared its first over-the-counter wearable blood sugar tracker, with Dexcom’s slimmed-down Stelo continuous glucose monitor.
Related: Orthobond wins FDA de novo approval...
