Recent revisions to the European Commission’s proposed AI Act have failed to resolve uncertainties around its interaction with medtech regulations, leaving crucial parts of the legislation open to interpretation. Industry representatives have said further steps must be taken.

DRGs are not doing what they were conceived to, ambulatory care needs more support and health care delivery across the country must be unburdened from bureaucracy, health minister Karl Lauterbach told the German hospital congress meeting during Medica 2022.

How much time do auditors need to spend on a manufacturer’s premises? A new EU document aims to clarify this and other issues, but questions remain

EU member state authorities overseeing devices have been putting out a series of messages that promise action to ease the implementation chaos surrounding the EU’s new medtech regulations.

The UK’s health technology assessment body recognizes that its traditional product evaluation processes are too slow for innovative medtech products. Its new “conditional recommendation” pathway aims to fix this.

Later market launch of innovations and a hit on EBITDA are simultaneously affecting medtech companies in Germany and central Europe as they strive to keep quality uppermost while battling the most frustrating confluence of negative effects on business than most companies have ever seen.

How much time do auditors need to spend on a manufacturer’s premises? A new EU document aims to clarify this and other issues, but questions remain

EU member state authorities overseeing devices have been putting out a series of messages that promise action to ease the implementation chaos surrounding the EU’s new medtech regulations.

With the EU’s Employment, Social Policy and Consumer Affairs Council due to discuss solutions to the MDR crisis on 9 December, the European Parliament is calling for risk-related deferrals.

Elypta’s MIRAM kit for multi-cancer early detection performed well in a large-scale study.

Using artificial intelligence and coronary computed tomography angiography Cleerly is trying to shift cardiology's focus from symptoms-based interventions to prevention and treatment of the underlying vascular disease.

Federated learning has taken another step forward thanks to new research that proves it is better at spotting brain tumors. 

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.

Japan-based Canon plans to launch a US-based medical imaging company near Cleveland to strengthen its US presence and competitiveness in the marketplace.

After winning US FDA clearance in 2021, Activ Surgical now also received the green light to market its visualization module for surgeons in Europe. 

Japan-based Canon plans to launch a US-based medical imaging company near Cleveland to strengthen its US presence and competitiveness in the marketplace.

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

In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb provides highlights from the recent HLTH conference in Las Vegas. Reed Miller and Barnaby Pickering offer an overview of the highly competitive diabetes tech market. We also talk about digital health in Germany and Europe.

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.