Regulatory Approvals

FDA approves Lumicell’s breast cancer visualization system

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...

FDA approves XStim spine fusion stimulator

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’s Smartinhaler gains clearance for use with AstraZeneca devices

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 submits final breast cancer cryoablation data to FDA

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 Announces First FDA De Novo Approval of an Antibacterial Coating for Tumor and Revision Orthopaedic Implants

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...

FDA issues 510(k) clearance for twiist insulin system

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...

FDA clears first over-the-counter wearable glucose tracker, with Dexcom’s Stelo

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 wins FDA de novo approval for antibacterial technology that could have vast device applications

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 eyes FDA submission as neurogenic bladder trial hits milestone

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,...
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