Latest regulatory news

FDA clearance for VySpine’s ClariVy Cervical IBF System

VySpine received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its ClariVy Cervical IBF System.

Designed for use in anterior cervical discectomy with fusion (ACDF) procedures, the ClariVy Cervical IBF System features cervical interbody fusion devices made from either PEEK Optima LT1 or PEEK Optima HA-Enhanced. PEEK Optima LT1 features radiolucency and a modulus of elasticity close to that of natural bone. PEEK Optima HA-Enhanced has embedded hydroxyapatite fibers to create a better bony apposition to the implant.

ClariVy is offered in numerous footprints and heights, ranging from 4mm to 11mm and available with or without locking screws. Additionally, ClariVy implants are available in a range of lordosis. The ClariVy Cervical IBF System also features IBF-S implants, which have self-drilling, self-locking screws for quick and easy fixation.

Spirometer, printer receives FDA approval

Vitalograph’s portable, lightweight, all-in-one desktop spirometer and printer received U.S. Food and Drug Administration (FDA) approval. The next-generation Alpha spirometer is a durable tool used for accurate respiratory diagnosis in adults and pediatrics.

“It’s very exciting and great timing to have another next-generation product available just as many healthcare sites are looking to reopen spirometry testing in the wake of the pandemic,” says Vitalograph’s Executive Vice President of Sales & Operations for North America, Troy Pridgeon.