Briefs

FDA Grants Approval to CeloNova Biosciences’ COBRA PzF Stent System

San Antonio–based, CeloNova Biosciences has received FDA approval for its Cobra PzF nano-coated coronary stent system.

The stent is indicated for improving coronary luminal diameter in patients, including those with diabetes mellitus, with symptomatic ischemic heart disease due to de novo lesions in native coronary arteries with reference vessel diameter of 2.5-4.0mm and lesion length of greater or equal to 24mm.

The stent was awarded CE Mark approval in 2012.

Elekta’s Radiosurgery System Receives Health Canada Approval

Health Canada issued a medical device license to Elekta’s Leksell Gamma Knife Icon radiosurgery system, which is used to target brain tissue.

The device provides the range for single dose administration or multiple treatments over time, which enables treatment of structures varying from small target sizes of a few millimeters to several centimeters, targets close to critical brain structures and new or recurring brain metastases.

Synergy Biomedical Acquires CE Mark for Biosphere Putty

Synergy Biomedical has received CE Mark clearance in the European Union for its synthetic bone graft, Biosphere Putty.

The putty uses bioactive glass in combination with a moldable phospholipid carrier.

The product was launched in the U.S. in 2013.

Neocis Gains FDA Clearance for Robotic System for Dental Implant Procedures

Miami–based Neocis has received FDA marketing clearance for its Yomi, a robotic guidance system for dental implant procedures.

Yomi is a computerized navigational system that assists in both the planning and the surgical phases of dental implantation surgery.

The product delivers physical guidance through the use of robotic technology that recognizes objects through touch and constrains the drill in position, orientation, and depth.

FDA Awards Clearance to Abbott’s Ablation Catheter

Abbott has gained FDA clearance of its sensor enabled FlexAbility ablation catheter designed to improve precision during cardiac ablation procedures to treat irregular heartbeat.

The device collects electrical current resistance and magnetic data to facilitate accurate mapping for treatment of sites that trigger or sustain abnormal heart rhythms.

Amend Surgical Nabs FDA Clearance for NanoFUSE BA

The company has received marketing clearance for NanoFUSE BA as a bone graft extender for spine and orthopedic applications.

The device has bioactive glass which facilitates operative site graft containment through rapid bone bonding and the subsequent activation of cellular bone formation.