LONDON – Brexit finally becomes a reality at midnight central European time on Jan. 31, but for the life sciences industry uncertainty continues, as the U.K. enters an 11-month transition phase during which the terms of its future relationship with the EU must be negotiated.

Medtronic plc has gained CE mark approval for its Cobalt and Crome portfolio, the company’s first implantable cardiac defibrillators (ICDs) and cardiac resynchronization therapy-defibrillators (CRT-Ds) to offer connected health via Bluesync technology. The portfolio will be rolled out on a country-by-country basis throughout Europe, with initial implants in select countries to begin soon.

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).