EDAP TMS, a developer of invasive medical devices, has received the US Food and Drug Administration’s (FDA) breakthrough device designation for its Focal One...
Axena Health has announced that its Leva Pelvic Health System received a new Healthcare Common Procedure Coding System (HCPCS) Level II code from the...
AIOMEGA, a Texas biomedical company, announced that AIO BREATHE, their medical device that treats Obstructive Sleep Apnea, has been cleared by the Food and...
Embolx Inc., a leading medical technology company developing microcatheters for arterial embolization procedures, is thrilled to announce that the U.S. Food and Drug Administration...
Spectral AI has received UK Conformity Assessed (UKCA) authorisation for its DeepView AI-Burn predictive software.
The authorisation allows the system to aid in burn wound...
Virtual Incision has received the US Food and Drug Administration (FDA) marketing authorisation of the MIRA Surgical System (MIRA) for colectomy procedures in adults.
MIRA...
Following positive clinical results, the US Food Drug Administration (FDA) has granted SeaStar Medical a humanitarian device exemption (HDE) approval for its Quelimmune selective...
IMRIS, Deerfield Imaging, the global leader in intraoperative imaging, announced that the company has received 510(k) clearance from the U.S. Food and Drug Administration...
Canadian company Momentum Health has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Momentum Spine app for remote monitoring...
