The U.S. FDA’s emphasis on internationalized regulations continues with the agency’s adoption of ISO 14971, the risk management framework published by the International Organization for Standardization (ISO). The FDA said it will accept declarations of conformity to the previous edition until December 2022, giving device makers roughly three years to update their systems.

Abbott Laboratories has received CE mark approval for its Tendyne transcatheter mitral valve implantation (TMVI) system, the first such device approved for use in Europe and the world. The system is intended for patients with leaky mitral valves that are beyond repair and those at high risk for open heart surgery.

BOGOTA, Colombia – Venezuela’s med-tech sector has been virtually decimated by the ongoing crisis, which has not only displaced millions of people but also destroyed the country’s economy over the past four years.

Diabetes is the first med-tech sphere that is coalescing for Verily Life Sciences LLC, but cardiology could be next. The South San Francisco-based business that’s part of Google parent Alphabet Inc. has received a second FDA clearance for its Verily Study Watch as an irregular pulse monitor. After a 2017 debut, it was first cleared by the agency about a year ago for use to take an on-demand electrocardiogram (ECG).

The latest global regulatory news, changes and updates affecting biopharma, including: Innate Immunotherapeutics, Australia’s Therapeutic Goods Administration