FDA approvals

Med-El USA’s cochlear implant (CI) system is approved for single-sided deafness (SSD) and asymmetric hearing loss (AHL). CI’s Synchrony and recently FDA-approved Synchrony-2 are now indicated for individuals 5 years and older with SSD who have profound sensorineural hearing loss in one ear and normal hearing or mild sensorineural hearing loss in the other ear, or individuals 5 years and older with AHL who have profound sensorineural hearing loss in one ear and mild to moderately severe sensorineural hearing loss in the other ear, with a difference of at least 15dB in pure tone averages between ears. 

B. Braun Interventional Systems Inc. (BIS) was granted Breakthrough Device Designation for its SeQuent Please ReX percutaneous transluminal coronary angioplasty (PCTA) drug-coated balloon (DCB) catheter for the treatment of coronary in-stent restenosis (ISR). Breakthrough designation will streamline the review process and timeline for bringing the treatment option to patients.

Certifications

Medicrea, with the clearance of the Tulip Genesis top-loading screw system designed to integrate seamlessly with UNiD Adaptive Spine Intelligence (ASI), completes its UNiD ASI platform technology. The Tulip Genesis system offers solutions for degeneration and complex deformity cases and is the only FDA-cleared top-loading screw system that can be used with the UNiD Rod.

Florida Anodize System & Technologies Inc.’s quality management system for its medical device surface coating services was audited by TUV SUD and found to be in full compliance with ISO 13485:2016.

Nanotech Precision, a manufacturer of micro-sized instruments and electrodes, has received ISO 13485:2016 for medical devices and quality management systems.