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...
The FDA granted marketing authorization for Peytant Solutions' AMStent tracheobronchial covered stent system. Plymouth, Minnesota-based Peytant designed its AMStent to treat pulmonary obstructions caused...
Gentuity received FDA 510(k) clearance for its HF-OCT imaging system with the Vis-Rx micro-imaging catheter. Sudbury, Massachusetts-based Gentuity received approval for the technology for...
Novocure announced the FDA treated its Optune Lua wearable device for treating metastatic non-small cell lung cancer.
Optune Lua uses tumor-treating fields (TTFields) to exert...
CMR Surgical announced the U.S. FDA has granted marketing authorisation for the Versius Surgical System, paving the way for a next-generation versatile, adaptable, and...
Momentis Surgical’s Anovo robotic surgical platform has secured 510(k) clearance from the US FDA for use in single-site, abdominal access ventral hernia repair.
The device...
Endostart received CE mark approval for the expanded use of its flagship Endorail product. Certaldo, Italy-based Endostart designed Endorail to provide efficiency and safety...
Iota Biosciences, a subsidiary of Astellas Pharma, announced that it received FDA investigational device exemption (IDE) for its bladder implant.
The FDA gave the go-ahead...
