Latest medtech regulatory news

ISO 13485:2016 certification renewed

Norman Noble Inc. achieved ISO 13485:2016 registration for its quality management system (QMS) following a full recertification audit by the British Standards Institute (BSI), a European Union Notified Body. ISO 13485:2016 registration demonstrates Norman Noble’s continued commitment to the highest level of medical device product quality and regulatory compliance. ISO 13485 registered since 2004, Noble Norman’s update supports customers’ efforts to maintain compliance with the latest domestic (FDA) and international (MDSAP and European MDR) regulatory requirements.

High-performance MR 7700 system

Royal Philips received FDA 510(k) clearance for its MR 7700 3.0T MR system. The MR 7700 expands scanning capabilities with a fully integrated multi-nuclei imaging and spectroscopy solution to explore new clinical pathways.

With its artificial intelligence (AI)-driven smart connected imaging, optimized workflows, and integrated clinical solutions, MR 7700 helps improve MR department productivity, enhance patient and staff experience, and deliver high-quality diagnostic imaging.

Via integration of a dual-tuned head coil, both multi-nuclei and conventional proton MR exams can be performed with the same coil and within the same user interface.

Onyx Frontier drug-eluting stent

Medtronic plc received U.S. Food and Drug Administration (FDA) approval for the Onyx Frontier drug-eluting stent (DES), which leverages the same platform as Resolute Onyx DES, but with an enhanced delivery system designed to improve deliverability and increase acute performance in challenging cases.

Design changes, including increased catheter flexibility, an innovative dual-layer balloon technology, and a lower crossing profile led to a 16% improvement in deliverability with Onyx Frontier vs. the previous generation Resolute Onyx DES. In addition to delivery system enhancements, Onyx Frontier offers a broad size matrix to treat more patients and is the only 2.0mm DES available in the U.S (similar to Resolute Onyx). Further, Onyx Frontier continues to provide 4.50mm to 5.00mm sizes that can expand to 6.00mm to support extra-large vessels.

Polymotion hip resurfacing system

The U.S. Food and Drug Administration (FDA) has granted a Breakthrough Device Designation for JointMedica’s Polymotion hip resurfacing system.

Exactech, a minority shareholder of JointMedica Ltd., is collaborating with the United Kingdom-based orthopedic device designer and manufacturer to deliver the next generation of hip resurfacing and holds exclusive global distribution rights to the product.

With more than three decades of experience using hard-on-hard articulations in hip resurfacing, Derek McMinn M.D., FRCS, and Ronan Treacy, M.D., FRCS, designed the Polymotion hip resurfacing system to leverage the clinically successful design principles of their previous hip resurfacing devices, now with advanced polyethylene and titanium manufacturing technology. The Polymotion hip offers biomechanical benefits of hip resurfacing but eliminates metal-on-metal articulating surfaces.