NEWS
EU urged to act on medical device availability
MedTech Europe – with the backing of 39 national associations, including BIVDA – is urging the EU to take action on the medical technology regulations (IVDR and MDR) to ensure the availability and competitiveness of medical devices. In an open letter to European Commissioner for Health & Food Safety, Stella Kyriakides, MedTech Europe asks for Commissioner Kyriakides’s leadership to make reform of these regulations her priority and to urge her successor to do the same to solve their ongoing serious implementation challenges. The industry body believes action is needed to reverse the exodus of innovation from Europe and to prevent further discontinuations of medical technology intended to protect patient safety and public health. MedTech Europe is proposing three
areas of action: 1. As an immediate outcome of the targeted evaluation running until end- 2025 – a package of legislative reforms for each of the two regulations should be developed to ensure that they deliver on their original objectives.
2. As urgently as possible – several ‘bridging measures’ are needed to support device availability and the viability of the medical technology industry. These measures cannot wait until the targeted evaluation is concluded and full packages of legislative reforms are written and published into EU law, which will take years. These measures should have sufficient legal weight to achieve the following: time and costs for certifying devices must be significantly reduced and made predictable; assessment of changes to medical technologies must be made more efficient; an accelerated pathway for breakthrough innovation should be put in place; adapt certification to follow a life-cycle approach.
3. On an ongoing basis – specific measures to improve the implementation of the regulations should continue to be pursued through existing work streams and tools (including guidance and implementing acts). Examples include reducing the technical documentation sampling burden, adopting wide use of electronic instructions for use and having the EU join the Medical Devices Single Audit Program.
12
Our Future Health hits a million participants
Our Future Health is now the largest longitudinal cohort study in the world that uses blood samples, with over a million people from across the UK having joined. The health research programme was set up with funding from UK Research and Innovation’s Accelerating Detection of Disease Challenge, delivered by Innovate UK.
It is an ambitious collaboration between
the public sector, life sciences companies and leading UK health charities. The programme aims to transform the prevention, detection and treatment of conditions such as: dementia, cancer, diabetes, heart disease and stroke. With eventually up to five million volunteers right across the UK, the goal is to create one of the most detailed pictures ever of people’s health. Our Future Health also has the largest ever number of participants from under- represented groups in a health research programme. It includes people from more diverse and representative populations from every part of the UK. This means
it can be used for research that benefits everyone, including tackling diseases that disproportionately affect some groups across society, thereby reducing health inequalities. Dr Raghib Ali OBE, CEO of Our Future Health, said: “We can now say that Our Future Health is the world’s largest health research programme of its kind. Our volunteers’ data is creating a transformative scientific resource that will power health discoveries for decades to come and help everyone live longer and healthier lives. Already, we have an incredibly detailed picture of the UK’s health, offering health researchers a window into the causes of every major common disease.”
New POC test for rapid cardiac diagnostics
A team of researchers from UCLA has introduced a deep learning-enhanced, paper-based vertical flow assay (VFA) capable of detecting cardiac troponin I (cTnI) with high sensitivity. The innovative assay holds the potential to democratise access to rapid and reliable cardiac diagnostics, particularly in resource-limited settings. The UCLA team has developed a high-sensitivity vertical flow assay (hs- VFA) that combines the precision of traditional laboratory testing with the convenience and affordability of point-of- care technologies. Their findings, detailed in a recently published paper in ACS Nano, demonstrate that this innovative platform can accurately quantify cTnI levels in just 15 minutes using a small sample of serum, making it ideal for rapid diagnostics in emergency settings or remote locations.
The core of this platform lies in the integration of deep learning algorithms with cutting-edge nanoparticle amplification chemistry. The hs-VFA system uses time-lapse imaging and computational analysis to enhance the detection of cTnI – a key biomarker for cardiac damage - achieving a detection limit as low as 0.2 picograms per millilitre (pg/mL). This level of sensitivity meets the requirements for high-sensitivity troponin testing, which is essential for early diagnosis of AMI. In rigorous testing using both spiked and clinical serum samples, the hs-VFA demonstrated high precision with a coefficient of variation (CV) of less than 7%. It also exhibited a strong correlation with gold-standard laboratory analysers. The hs-VFA also demonstrated an extensive dynamic range, making it suitable for monitoring at-risk patients over time. n Han GR, Goncharov A, Eryilmaz M, et al. Deep Learning-Enhanced Paper-Based Vertical Flow Assay for High-Sensitivity Troponin Detection Using Nanoparticle Amplification. ACS Nano. Published online October 4, 2024. doi:10.1021/ acsnano.4c05153
DECEMBER 2024
WWW.PATHOLOGYINPRACTICE.COM
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52
