Regulatory Approvals

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...

Orthobond has secured FDA de novo approval for its Ostaguard antibacterial technology that could one day be used for a wide range of medical...

SpineX has closed recruitment for a clinical study investigating its neuromodulation device to treat urinary incontinence. Data from the trial, which began in May 2022,...

Spirair has secured 510(k) clearance for its SeptAlign system from the US Food and Drug Administration (FDA) for its use in the mechanical correction...

Medical Microinstruments announced today that the FDA granted de novo clearance for its Symani surgical robot platform.Clearance covers soft tissue manipulation to perform microsurgery....