Medtech Regulatory News
UK government accepts proposals to tackle bias in medical devices
The UK government has accepted recommendations from a UK-first independent review to tackle potential bias in the design and use of medical devices. Read more
11 Mar 2024
Survey suggests over a third have no understanding of AI regulations
A survey on emerging AI regulations from The Pistoia Alliance showed that just 9% of respondents said they know EU and US AI regulations well, with more than a third (35%) having no understanding at all. Read more
21 Feb 2024
UK Approved Bodies found Team-AB to aid regulatory understanding
UK Approved Bodies and those undergoing the designation process have announced the foundation of Team-AB. Read more
19 Feb 2024
InnoScot Health to offer personalised guidance for regulatory approval
InnoScot Health will deliver a further three days of free personalised guidance for those looking to achieve regulatory approval for a medical device or in vitro diagnostics (IVD) in the UK and US. Read more
8 Feb 2024
MHRA designates LNE-GMED and Scarlet become Approved Bodies
LNE-GMED and Scarlet have been added been given approved body status by the Medicines and Healthcare Products Regulatory Agency (MHRA). Read more
29 Jan 2024
InnoScot Health welcomes MHRA's regulatory roadmap
InnoScot Health has announced its backing of the new regulatory roadmap released by the MHRA, calling it ‘another important step towards easier navigation of the pathway for getting medical device innovation safely into patients' hands. Read more
29 Jan 2024
The impact of the new EU Product Liability Framework on medtech
Ed Turtle and Anushi Amin, associates at law firm Cooley, analyse the new Product Liability Directive which will enter into force in 2024 and apply from 2026. Read more
28 Feb 2024
Why AI act must ensure safety without hampering innovation
Elaine Gemmell, head of regulatory affairs at InnoScot Health, analyses where the new EU AI Act legislation is beneficial and where it must remain flexible. Read more
22 Feb 2024
Setting new standards for wireless medical devices
Ravi Subramaniam, director, Conformity Assessment for IEEE SA, outlines the IEEE’s new standards for wireless medical devices in response to the FDA refusing to accept medical devices and associated systems due to cybersecurity concerns. Read more
19 Feb 2024
How new EU Batteries Regulation may affect UK medical device manufacturers
Sidley Austin’s Josefine Sommer, partner specialising in food, drug and medical device regulation, and Michelle Gandolfo, managing associate, outlines how new European battery regulations may impact medical device manufacturers in the UK. Read more
12 Feb 2024
Change is coming: European In Vitro Diagnostic Regulation
Claire Ryan, global head of QA/RA, Joanne Cross, director of marketing and Jennifer Golding, product manager at Yourgene Health discuss the in vitro diagnostic regulatory landscape in Europe and how the ongoing changes will help improve safety. Read more
30 Jan 2024
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Thomas Averre is a Director at Tarleton Communications, a specialist life sciences public relations agency. Read more
Medical devices spur growth for software and electronics firm
Embedded systems consultancy ByteSnap Design has announced robust sales in 2023, largely driven by hardware and software projects in the medical devices industry, which has led to the consultancy expanding its core team to 43. Read more
18 Mar 2024
Academic warns next-gen medtech held back by cost and regulation
Next generation medical technologies with the potential to transform NHS treatments for conditions such as osteoarthritis are being held back by over-complicated regulations and high costs, a leading academic has warned. Read more
14 Mar 2024
Junkosha sets date for Technology Innovator of the Year ceremony
Junkosha, a sophisticated fluoropolymer application technologies specialist, has announced that its second Technology Innovator of the Year Award ceremony will take place on April 18th, 2024, via livestream on YouTube. Read more
14 Mar 2024
Sooma Medical receives €5m funding for tCDS treatment
Sooma Medical, a provider of brain stimulation treatments for psychiatric and neurological disorders, has announced new growth funding of €5 million. Read more
13 Mar 2024
N-Tidal study underway on breathing difficulties in young children
A new pilot study is underway in partnership with the University of Nottingham and Nottingham University Hospitals NHS Trust to investigate the use of a technology for diagnosing and monitoring respiratory conditions like asthma in children. Read more
11 Mar 2024
From parts to perfection: Automating for the smallest devices
Tom Cash, director of Siemens parts supplier Foxmere, explains why OEMs need to automate high precision assembly. Read more
18 Mar 2024
And breathe! Outsourcing stability studies for inhalation testing
Malcolm Saxton, senior consultant for chemistry at Broughton, explores the benefits of outsourcing stability studies for inhalation devices. Read more
18 Mar 2024
Signed, sealed, delivering: University of Galway & Medtronic tie-up
After striking a €5 million signature partnership with Medtronic, president of University of Galway Professor Ciarán Ó hÓgartaigh, explains more about the significance of the partnership. Read more
15 Mar 2024
Making things stick: DuPont's latest adhesive offering
Following the launch of its new Liveo soft skin conductive tape and soft skin adhesive at COMPAMED and MEDICA in Dusseldorf in November, Ian Bolland spoke to Jennifer Gemo, global marketing leader – healthcare, DuPont to find out more. Read more
13 Mar 2024
Back to the future?
Ian Bolland reflects on the start of the year in medical technology in the UK, and bids farewell. Read more
15 Mar 2024
Why Live Data is behind successful NHS engagement
Oli Hudson, content director at Wilmington Healthcare, explores why smart, accessible and accurate NHS customer data is vital for UK medtech. Read more
11 Mar 2024
Harnessing wearable technology for real-world data
Claude Price, vice president and head of clinical data management at Quanticate explains the fundamental use of wearables for collecting real-world data, especially in clinical trials. Read more
4 Mar 2024
How data helps medtech companies adapt to market changes
Kyle Forcier, life sciences expert and former supervisor at Johnson & Johnson, explains what obstacles that medtech needs to overcome, even in a golden era. Read more
1 Mar 2024
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Intelligent cameras in the service of health: How businesses benefit and get started
AI plays a key role in the digital age. Self-learning algorithms can improve processes and be used in production, laboratory analysis and diagnostics. This is because classical image processing solutions work with a fixed set of rules. Read more
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Thomas Averre is a Director at Tarleton Communications, a specialist life sciences public relations agency. Read more
Driving AI insights into practical healthcare
Ian Bolland is joined by Mark Ratnarajah from C2AI, who talks about driving insights into practical healthcare solutions and how his role, background and experience has formed his views on how data and AI technology can aid the healthcare sector. Read more
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Direction and discipline: Do you have a comms strategy?
Thomas Averre, Director at Tarleton Communications, a specialist life sciences public relations agency, breaks down the basics of a communication strategy. Read more
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14 Nov 2023