RapidAI has received FDA 510(k) clearance for Lumina 3D by RapidAI—an industry-first, automated 3D imaging reconstruction solution designed to replace manual workflows with an...
The US Food and Drug Administration (FDA) has granted 510(k) clearance for Imperative Care’s Zoom System, marking an advancement in stroke thrombectomy procedures.
The clearance...
Instylla announced it has won FDA 510(k) clearance for its Tembo Embolic System. Bedford, Massachusetts-based Instylla said the Tembo system is a bioresorbable embolisation...
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,...
