SYNDEO Medical, a Belgium-based leader in diagnostic and interventional procedural solutions, announces that its two flagship product brands, SYNDEOPack Interventional Procedure Packs™ and Xssential...
Zeta Surgical announced the FDA granted 510(k) clearance for its Zeta Navigation System for expanded capabilities. The clearance applies to use with expanded instruments...
Imbed Biosciences announced U.S. Food and Drug Administration 510(k) clearance to market Microlyte Ag/Lidocaine, the first antimicrobial wound dressing to integrate lidocaine for the management...
The US FDA has granted investigational device exemption (IDE) approval to commence the ELITE-BTK trial of MAGNITUDE, a drug-eluting bioresorbable scaffold. The trial is...
NeurAxis shared the FDA granted an expanded 510(k) clearance for its IB-Stim non-implanted nerve stimulator. IB-Stim delivers nerve stimulation for functional abdominal pain relief....
Quanta Dialysis Technologies received FDA 510(k) clearance for the use of its dialysis system in the home. Beverly, Massachusetts–based Quanta said in a news...
Distalmotion received FDA de novo approval for its Dexter surgical robot for adult inguinal hernia repair. Lausanne, Switzerland–based Distalmotion can now bring Dexter to...
Vantis Vascular received FDA 510(k) clearance for its CrossFast integrated microcatheter guide extension system. San Jose, California-based Vantis develops the CrossFast system along with...
Dutch-Finnish startup Lapsi Health has gained U.S. Food and Drug Administration clearance for its new digital stethoscope, Keikku.
Unlike traditional stethoscopes, Keikku (translated from Finnish...
