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Ben Kemp

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BIVDA member PocDoc’s groundbreaking smartphone diabetes test set for NHS roll-out

BIVDA member PocDoc have launched a world-first health check for type 2 diabetes that combines the gold-standard finger prick test with patients' smartphones. The test, which cuts diagnosis time from months to minutes, will be piloted by NHS trusts in Cumbria and the North East of England through the Diabetes Health Check app. Patients begin the test by applying a…
Ben Kemp
August 26, 2025
Membership NewsMembership News Archive

How Our Future Health can support SMEs

The Office for Life Sciences is spotlighting how research organisations, namely UK Biobank, Genomics England and Our Future Health, can support SMEs. This week, they are highlighting the latter charity. Our Future Health is the UK’s largest ever health research programme, designed to develop new ways to prevent, detect and treat diseases. Their mission is to create an incredibly detailed…
Ben Kemp
August 26, 2025
HighlightsHighlights Archive

WHO releases new Target Product Profiles for tuberculosis screening tests

The World Health Organization (WHO) has published updated Target product profiles (TPPs) for tuberculosis (TB) screening tests. This follows the recent publication of a TPP for serious bacterial infection among young infants, including neonatal sepsis, covered in last week's newsletter. These TPPs define the most important characteristics and requirements to be considered in the development of new tests for systematic…
Ben Kemp
August 26, 2025
Membership NewsMembership News Archive

Apply for the Department of Business and Trade’s King’s Awards for Enterprise

BIVDA members may be interested in applying for the King’s Awards, the UK’s most prestigious business awards, which celebrate outstanding achievements in UK enterprise. Make sure to apply before the closing date on 1pm on Tuesday 9 September 2025. There are four categories: Innovation International Trade Sustainable Development Promoting Opportunity (through social mobility) The Awards are free to enter, and…
Ben Kemp
August 26, 2025
Membership NewsMembership News Archive

NICE Webinar: Introduction to NICE healthtech evaluation

NICE is transforming its approach to healthtech assessment, but what does this mean for your technology? Join their online seminar on Tuesday 23 September 2025, 1pm to 4pm BST. Designed for healthtech developers and market access specialists, this interactive session explains NICE’s role in healthtech market access and how they support healthtech developers to get the best care to patients,…
Ben Kemp
August 26, 2025
Membership NewsMembership News Archive

Join Task and Finish Group to rewrite BIVDA’s Code of Ethical Conduct

BIVDA are updating our Code of Ethical Conduct to ensure it reflects our position in 2025 and our commitments to MedTech Europe. Members have individually expressed an interest in assisting, therefore we are assembling a small group of volunteers to work on this document as a task and finish group. It will cover aspects impacted by product regulation and compliance,…
Ben Kemp
August 26, 2025
Membership NewsMembership News Archive

BIVDA welcomes new member Mantara Health Ltd

  BIVDA are pleased to welcome Mantara Health as new members! Founded in 2020, Mantara Health Ltd has developed the first MHRA-registered, UKCA/CE accredited pharmacogenomic panel test for commercial use in the UK, validated and using the same algorithm as the Lancet-published Prepare study from February 2023. Over the last couple of years, Mantara Health has won the 2023 Start…
Ben Kemp
August 25, 2025
FDA updates Regulatory Affairs NewsletterFDA Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

FDA New Classifications published

Dear members, Neil Plumridge spotted the following Politico article regarding updates to FDA classifications: Devices, diagnostics and digital health CLASSIFICATION ORDER BONANZA: The FDA’s Center for Devices and Radiological Health today issued nine medical device classification orders, primarily (eight out of the nine) for diagnostic products. The issuance of these orders is the last step in formally codifying a new…
Ben Kemp
August 22, 2025
MedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

For input by 29/8: ECHA RAC Talc Opinion/Classification Carcinogenic 1B

Dear members, please see below call for feedback regarding the classification of ‘Talc’ as Class 1B Carcinogen. The focus is on Medial devices. I’m not aware of any IVD devices that utilise ‘Talc’, but if your impacted please contact me via regulatory@bivda.org.uk We are writing to inform you that recently, the European Chemical Agency’s (ECHA) Risk Assessment Committee (RAC) published…
Ben Kemp
August 22, 2025
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