Neocis announced today that it filed for FDA 510(k) clearance for its Yomi edentulous splint to aid its dental robotic surgical system. The Miami-based company’s new splint is designed to enable the Yomi dental robotic system to go beyond placing implants for partially edentulous patients, with new capabilities for assisting doctors with full arch implant […]
FDA clears new Conformis VHP sterilizers
Conformis (NSDQ:CFMS) has secured an FDA 510(k) clearance for its new vaporized hydrogen peroxide (VHP) sterilizers, the company said in an SEC filing filed this week. In December 2019, Conformis announced that it received a warning from the FDA regarding issues related to the VHP sterilizers that it uses as an alternative sterilization method for a […]
CoNextions wins FDA 510(k) nod for tenodesis product
CoNextions announced that it won FDA 510(k) clearance for its Coronet system for the fixation of tissue to bone and tissue to tissue. The Coronet system is a tenodesis product designed to improve the soft tissue fixation strength of these types of repairs when compared to conventional suture repairs. Salt Lake City–based CoNextions developed the […]
TransEnterix secures FDA clearance for ‘machine vision’ in robotic surgery
TransEnterix (NYSE:TRXC) said today that it has received FDA 510(k) clearance to add an artificial intelligence feature to its Senhance robotic surgery system. The new Intelligent Surgical Unit on the system enables the camera to automatically move for a surgeon during a procedure, responding to commands and recognizing certain objects and locations in the surgical field. TransEnterix […]
FDA asks manufacturers to help prevent protective gear shortages
The FDA said today it wants to hear from surgical mask and gown manufacturers that might be able to increase or speed production to prevent shortages in the U.S. during the COVID-19 outbreak. The agency said it may expedite review of manufacturing site changes or premarket submissions of personal protective equipment, including protective clothing, gowns, […]
Soliton Rapid Acoustic Pulse device wins 510(k) premarket notification
Soliton (NSDQ:SOLY) today said it received special 510(k) premarket notification for its Generation II Rapid Acoustic Pulse device. The Generation II RAP device features the same tattoo-removal technology as the first generation but is modified for improved ease of use in physician offices. “The FDA clearance of our Generation II RAP device marks yet another milestone […]
Kinepict Health wins FDA nod for imaging tech
Kinepict Health announced today that it won FDA 510(k) clearance for its Kinepict Medical Imaging Tool (KMIT) imaging software with its proprietary digital variance angiography (DVA). The Budapest, Hungary-based company’s DVA technology is designed with an algorithm to use advanced statistical methods in visualizing blood vessels by identifying contrast-induced changes in an X-ray angiography image […]
Pavmed to resubmit carpal tunnel device 510(k) application
Pavmed (NSDQ:PAVM) said today that it has reapplied for FDA 510(k) clearance for its CarpX device designed to treat carpal tunnel syndrome. In August 2018, the FDA group reviewing the application for CarpX requested that the company resubmit the application because the group hadn’t reached a consensus within the designated review period. The resubmission incorporates data […]
Life Spine wins additional clearance for Lateral ProLift expandable system
Life Spine announced that it won additional FDA clearance to market its Lateral ProLift expandable system as it prepares to launch 20 new products in 2020. The Lateral ProLift system is designed to offer a micro-invasive solution for lateral lumbar interbody fusions, minimizing impaction, preserving end-plate integrity and maximizing indirect compression, according to the company’s […]
Masimo gains FDA clearance for new respiration rate measurement system
Masimo (NSDQ:MASI) said today that the FDA has granted 510(k) clearance to its continuous RRp (respiration rate from the photoplethysmograph) monitoring of adult and pediatric patients with Rad-97, Radical-7, and Radius-7 Pulse CO-Oximeters. With this clearance, both continuous and spot-check RRp are now available in the U.S., supported in a variety of pulse oximetry sensors and […]
Baxter wins FDA nod for next-gen staple-line reinforcements
Baxter (NYSE:BAX) announced today that it received FDA 510(k) clearance for the new generation of its Peri-Strips Dry with Veritas collagen matrix (PSDV) staple-line reinforcement material. The “PSDV with secure grip” is now available with peel-and-secure technology. Baxter touts the new generation of the product as two times faster in preparation when compared to the previous […]
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