Origami Surgical today announced that the FDA has granted 510(k) clearance for three new types of sutures for its StitchKit robotic surgery platform. The company describes StitchKit as a patented suture delivery and retrieval system designed so sutures are efficiently inserted and needles are safely removed from the surgical field. StitchKit also allows the robotic […]
510(k)
Misonix gains FDA clearance for ultrasonic surgical platform
Misonix (NSDQ:MSON) said today that it received FDA 510(k) clearance for a new ultrasonic surgical platform. The Nexus platform combines all the features of Misonix’s existing solutions, including BoneScalpel, SonicOne and Sonastar, into a single, fully integrated platform that was also designed to accommodate future solutions. The Nexus platform is driven by a new […]
What does FDA really mean when something is 510(k) exempt?
FDA undoubtedly provided some good news to the medical device industry last month when it proposed exempting hundreds of moderate-risk devices from 510(k) requirements. But don’t break out the champagne just yet if you happen to be developing a device that appears to be on the list. Even when the agency says a particular generic […]
Changing your medical device: What you need to know
When it comes to changing a medical device, one of the most important decisions can involve whether to log it in as an internal letter-to-file or submit a special 510(k) or PMA supplement with FDA. In many cases, company officials don’t do some initial investigation before making the decision, according to Vascular Sciences President Michael Drues, who has […]
TransEnterix submits 510(k) application for Surgibot System
TransEnterix (NYSE:TRXC) said yesterday that it submitted an application for 510(k) clearance from the FDA for its SurgiBot robot-assisted surgery device. Research Triangle Park, N.C.-based TransEnterix claims the SurgiBot as the 1st patient-side robotically enhanced laparoscopy platform, designed to be wheeled to a patient’s bedside. "TransEnterix is pleased to deliver on our commitment to file […]
InvisionHeart wins FDA nod for InvisionECG
InvisionHeart said it won 510(k) clearance from the FDA for the commercial sale of its InvisionHeart electrocardiogram system. The InvisionHeart ECG system is designed to help manage and capture 12-lead ECGs, the company said, allowing physicians to visually compare, report on and store high-quality electrocardiograms. The system is cloud-based and can be accessed through a […]
