The US Food and Drug Administration is alerting health care providers that some cardiac devices from a major supplier are in short supply.

The Council of EU’s agenda for the critical upcoming health council meeting confirms position of EU Medical Device Regulation in day’s running, along with other key health issues.

Certain active products without an intended purpose, where member states had concerns over potential inadequate regulation, now fall under stricter Medical Device Regulation rules.

UK policymakers will need to walk a fine line when developing regulation for AI as a medical device. An independent expert review sets out the need for carefully balanced rules that support innovation without allowing unsafe products to enter the market.

The US FDA has approved a temporary prostatic stent from SRS Medical Systems that allows urine to flow through the urethra when it is blocked by an enlarged prostate.

Are too few digital health care apps approved for reimbursement in Germany? That’s not the point, says the health care ministry, urging a look at the bigger strategic picture.

The Council of EU’s agenda for the critical upcoming health council meeting confirms position of EU Medical Device Regulation in day’s running, along with other key health issues.

Certain active products without an intended purpose, where member states had concerns over potential inadequate regulation, now fall under stricter Medical Device Regulation rules.

The latest notified body listing brings total number of EU designated Medical Device Regulation testing and certification organizations to 35.

The US Food and Drug Administration is alerting health care providers that some cardiac devices from a major supplier are in short supply.

Over four years in the making, the deal will spin-off General Electric’s health care business into a separate public company.

GE Healthcare and MediView announced a partnership to co-develop a technology platform that integrates medical imaging into mixed reality solutions.

The US FDA has approved a temporary prostatic stent from SRS Medical Systems that allows urine to flow through the urethra when it is blocked by an enlarged prostate.

Medtech Insight followed-up with Cordis CEO Shar Matin to talk about the company’s path forward as an innovative intervention company following the acquisition of MedAlliance.

Insulin pumps have lagged behind continuous glucose monitors in terms of market penetration due to their cost and the complex regulatory framework that surrounds them. Elizabeth Gasser, chief strategy officer at Tandem Diabetes spoke to Medtech Insight about these challenges and how the company is taking a slightly different approach to pumps.

GE Healthcare and MediView announced a partnership to co-develop a technology platform that integrates medical imaging into mixed reality solutions.

A newly cleared Apple Watch app will allow people living with Parkinson’s to more easily track tremors, dyskinesia and other symptoms.

This year’s annual HLTH meeting drew more than 9,000 people to Las Vegas from 13-16 November and hundreds of exhibitors. In this first part of a two-part roundup, Medtech Insight highlights interviews with C-suite executives at Mirvie, Grail, Biofourmis, Komodo Health and Babson Diagnostics.

One-year data from a randomized controlled trial showed Zimmer Biomet’s mymobility app paired with the Apple Watch can effectively guide rehabilitation following knee-replacement surgery.

Founded with a vision to change point-of-care diagnostics, Osler Diagnostics has raised nearly $200m to develop and commercialize a platform that promises to revolutionize diagnostics with just a drop of a patients’ blood.

NuraLogix developed machine-learning models that use facial blood flow patterns to predict disease. The company plans to pursue US FDA de novo authorization for its blood pressure monitoring module first in 2023.