Regulatory Approvals

SurGenTec wins FDA nod for hydrophilic synthetic bone graft

SurGenTec announced today that it received FDA 510(k) clearance for its OsteoFlo HydroPutty synthetic bone graft.OsteoFlo HydroPutty follows the company’s OsteoFlo NanoPutty, which received...

RDS granted CE mark for MultiSense remote monitoring wearable

Stéphanie Hilbold, director of quality assurance and regulatory affairs at RDS, said: “Achieving this pivotal milestone is testament to the hard work of our...

EDAP obtains FDA breakthrough status for endometriosis device

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 secures new HCPCS code for Leva Pelvic Health System

Axena Health has announced that its Leva Pelvic Health System received a new Healthcare Common Procedure Coding System (HCPCS) Level II code from the...

FDA Clears AIOMEGA’s AIO Breathe, for Treatment of Obstructive Sleep Apnea

AIOMEGA, a Texas biomedical company, announced that AIO BREATHE, their medical device that treats Obstructive Sleep Apnea, has been cleared by the Food and...

New Soldier® High Flow Microcatheter Granted FDA Clearance

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’s DeepView software secures UKCA authorisation

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 secures FDA authorisation for MIRA Surgical System

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...

SeaStar’s device granted humanitarian exemption approval for children with AKI

Following positive clinical results, the US Food Drug Administration (FDA) has granted SeaStar Medical a humanitarian device exemption (HDE) approval for its Quelimmune selective...
1...555657...116Page 56 of 116

Latest articles