Regulatory Approvals

Nalu Medical announced the FDA cleared expanded labelling of its peripheral nerve system to include whole-body MRI use. The clearance gives physicians greater flexibility...

Gravitas Medical has garnered a second U.S. Food and Drug Administration (FDA) 510(k) clearance for its Entarik technology for neonatal patients. “We are extremely pleased...

The US Food and Drug Administration (FDA) has granted approval to the MediBeacon Transdermal GFR (TGFR) system for evaluating kidney function in individuals with...

The US Food and Drug Administration (FDA) has granted investigational device exemption (IDE) approval for NextBioMedical’s randomised trial involving its fast-resorbable embolic microsphere, Nexsphere-F,...

SurGenTec has gained 510(k) clearance for OsteoFlo HydroFiber, a synthetic material for use in spinal surgery, from the US Food and Drug Administration (FDA). For...

CergenX announced the FDA granted breakthrough device designation for its Wave device for neonatal brain monitoring. Additionally, the FDA accepted the Cork, Ireland-based company...

The US Food and Drug Administration (FDA) has granted clearance to icotec for the use of its BlackArmor implants in treating de novo spinal...

Q’Apel Medical received CE mark certification for its Armadillo SelectFlex Neurovascular Access System. The 7F system uses the company’s SelectFlex Technology and is indicated...

Biobot Surgical received CE mark for its Mona Lisa 2.0 surgical robotic platform for urology applications. Approval in Europe adds to existing approvals in...