Current regulatory news

FDA 510(k) clearance for miniature robotic system

PHOTO COURTESY OF THINK SURGICAL

THINK Surgical received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its TMINI Miniature Robotic System (TMINI 1.1). The software assists surgeons performing total knee arthroplasty procedures through a robotic handpiece automatically compensating for surgeon hand movement to locate bone pins along precisely defined planes.

The new TMINI PRO workflow enables positional refinement and optimization of the implant tailored to the patient’s needs. Dynamic data capture and real-time feedback allow surgeons to make positional adjustments to help fine tune implant positioning and stability. The intuitive workflow can be customized around surgeon preferences and implant philosophy choices. Surgical plan adjustments are wirelessly transmitted to the TMINI Robot.

THINK Surgical offers two platform options for TMINI 1.1: an open platform allowing the customer to choose from a range of implants on the robot, and an exclusive platform where the customer gains access to the robot for loyalty to a single implant brand. The company plans to continue adding new options to its open implant library.

ISO 13485 certification achieved for quality management system

Neuromodulation and digital health company Avation Medical received the International Organization for Standardization (ISO) 13485 certification for its quality management system (QMS). ISO 13485 recognizes companies demonstrating high quality standards in the design, production, representation, and servicing of regulated medical devices through robust policies and procedures. An extensive audit of Avation Medical’s facilities was conducted by independent third-party certification firm TÜV SÜD America Inc.

Avation Medical is the developer of the recently released Vivally System, the first U.S. Food and Drug Administration (FDA)-cleared non-invasive, physiological closed-loop neuromodulation system to treat overactive bladder (OAB) without surgery or drugs. The device uses proprietary algorithms and electromyographical (EMG) sensors to continuously read the patient’s EMG signal and adjust the level of stimulation energy delivered to the tibial nerve. Vivally is worn on the ankle and used by patients at home for therapy sessions lasting 30 minutes as infrequently as once per week.