21st July 2023

UK Industry Lambasts Government For High Rebates In Proposed New Statutory Pricing Scheme

Proposed changes to the UK statutory pricing scheme from 2024 would see a slight drop in the rebate rate compared with that applied to drug sales this year, but the ABPI warns that the clawbacks planned are still much too high and that the move could undermine talks on a new voluntary scheme.

5th June 2023

What Does The EU Regulation On HTA Mean For Medtech And When Will It Apply?

Several updates have come in recent weeks on the European Commission’s planned new Regulation on HTA, including a list of stakeholder members and updated rolling timeline. Medtech Insight explains how and when this legislation will affect the medtech sector.

5th June 2023

Therapy Chatbots And Medtech Laws: Why AI App Developers Must Tread Carefully

With the rise of AI chatbots enabling rapid access to personalized mental health support and lifestyle advice, app developers must know when a product is legally a medical device. Medtech regulatory lawyer Erik Vollebregt explains what EU law says, and how to avoid mistakes.

5th June 2023

Genomic Tests Eliminate ‘Diagnostic Odysseys’ ̶ Why Are They Underutilized In The UK?

Genomic diagnostics provide significant value to the health system, but England’s unclear funding pathways and commissioning processes are preventing these tests from reaching patients, a report by trade body BIVDA reveals.

23rd February 2023

Why NICE Is Building The Medtech Innovation Plane As It Flies

England’s NICE is ditching the rulebook in favor of “failing forward faster” when it comes to tackling medtech innovations. The organization’s interim director of medical technology says this approach mirrors the entrepreneurial nature of the medtech, diagnostics and digital sectors.

9th February 2023

SME Success: How Eyenuk Traversed "Stringent" EU MDR For AI Eye Screening System

9th February 2023

Innovative Diagnostic For Babies Wins NICE Early Value Assessment Pilot Backing

An innovative genetic test that can detect which babies are likely to develop deafness if treated with a common antibiotic is set to receive conditional funding in the UK under NICE’s rapid evaluation pilot scheme.

20th January 2023

German Notified Body Latest To Be Designated Under MDR

The latest notified body to be listed under the EU Medical Device Regulation brings the total number to 37.

17th January 2023

UK Has ‘Much Room For Improvement’ On Genomic Testing Access

UK patient outcomes would improve under clearer, standardized market access or reimbursement pathways for advanced diagnostic tests, such as those used to screen for cancer, trade groups say.

17th January 2023

Could Smart Watches And Phone Apps Detect Alzheimer’s Years Before Symptoms Present?

Investigational therapies are finally achieving some success in treating Alzheimer’s disease, but a cure is not yet in sight. Medtech now has a golden opportunity in pre-symptomatic detection, according to digital health tech research initiative, EDoN.