Regulatory Approvals

NeuroBionics, a neurotech company revolutionising neuromodulation therapy with minimally invasive implantable devices, today announced the successful close of its $5 million Seed Round. The...

Stereotaxis has won European CE mark approval for its MaGiC ablation catheter, a robotically navigated device for the treatment of heart arrhythmia. Shares in the...

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...