Medtech Regulatory News
MTI
New regulatory appointment can help take formal NHS Scotland partner to ‘next level’
A new appointment for formal NHS Scotland partner InnoScot Health is expected to further boost its regulatory expertise in medical device development, from initial selection through to commercialisation according to the company. Read more
23 Jul 2024
Anaconda Biomed
Anaconda Biomed receives IDE approval for enrollment in ATHENA study
Anaconda Biomed S.L., a medical technology company developing next-generation thrombectomy systems, has announced that it has received conditional IDE approval from the FDA to begin the ATHENA study of its ANA Funnel Catheter. Read more
18 Jul 2024
Roche
Roche receives CE Mark for its AI-enabled continuous glucose monitoring solution
Roche has announced that it has received the CE Mark for its Accmilestone paves the way for the solution to be made available to people living with type 1 and type 2 diabetes. Read more
9 Jul 2024
LFH Regulatory
LFH Regulatory celebrates five years of success and growth
LFH Regulatory – a Yorkshire based medical device and IVD consultancy specialising in the field of regulatory, quality and clinical affairs, celebrated its fifth anniversary in June 2024. Read more
3 Jul 2024
Shutterstock
Front Line Medical Technologies announces CE marking for COBRA-OS
Front Line Medical Technologies has announced that its COBRA-OS (Control Of Bleeding, Resuscitation, Arterial Occlusion System) has officially been granted CE marking under the new European Medical Device Regulations. Read more
26 Jun 2024
Penumbra
Penumbra announces European launch of its most advanced neuro access offerings
Penumbra has announced the CE Mark and European launch of BMX 81 and BMX 96. These devices are designed for neurovascular management of ischemic and hemorrhagic stroke and are Penumbra’s most advanced neuro access offerings. Read more
25 Jun 2024
UncleFredDesign / shutterstock.com
Trying to keep pace: Technology and regulation
Fiona Maini, senior director global compliance and strategy at Medidata, a Dassault Systèmes company, outlines the challenges that regulation has with keeping up with technology in 2024. Read more
19 Mar 2024
bfk / shutterstock.com
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
gopixa / shutterstock.com
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
LeoWolfert / Shutterstock.com
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
Zerbor / shutterstock.com
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
Sponsored
rh2010_Adobe Stock
Austria: An attractive research centre
Medical technology is one of the most innovative sectors in a time that is not exactly lacking in technological developments. Austria occupies an internationally recognised position in this field. Read more
4D Medicine
4D Medicine raises £3.4m for unique biomaterial platform
4D Medicine, a spin-out from the Universities of Birmingham and Warwick has raised £3.4m ($4.4m) in a Series A investment. The funding round was backed by Oshen Holdings, DSW Ventures, SFC Capital, Boundary Capital and several private investors. Read more
26 Jul 2024
Abbott
Abbott rolls out 'next-generation' of heart valve technology across UK & Ireland
Abbott is rolling out the latest iteration of its Navitor transcatheter aortic valve implantation (TAVI) system, the Navitor Vision valve, across the UK and Ireland. Read more
25 Jul 2024
VentriJect
Danish MedTech start-up invited to present at United Nations
VentriJect, a Danish MedTech start-up, has been invited to the United Nations General Assembly (UNGA) in New York to demonstrate Seismofit, its portable and fast VO2 max estimation solution. Read more
25 Jul 2024
Cresset
Cresset integrates Spark solution in latest release of Flare platform
Cresset has announced the release of V9 - the latest version of its Flare platform for ligand-based and structure-based design, which includes a full integration of Spark, the company's bioisostere replacement solution. Read more
25 Jul 2024
Medovate
Medovate signs distributor agreement with Temena for "game-changing" SAFIRA technology
Medovate has concluded a distribution agreement with Germany-head quartered Temena providing the distribution rights for SAFIRA (SAFer Injection for Regional Anaesthesia) across Germany, France, Italy and Spain Read more
24 Jul 2024
Pixels Hunter / Shutterstock.com
Another around of key advisors appointed by Downing Street and health and tech ministers
Chris Whitehouse, a political consultant and expert on medical technology policy and regulation at Whitehouse Communications, an advisor to medtech suppliers, chair of the Urology Trade Association, , high Read more
26 Jul 2024
Shutterstock
Increasing combination of AI and FemTech: Opportunities and challenges
The intersection of technology and healthcare has given rise to a burgeoning industry known as femtech, which focuses on female health and wellbeing. Leeanne Baker, managing director - senior QA/RA consultant at IMed Consultancy discusses. Read more
25 Jul 2024
MedTalk Podcast
Using 3D printing in life sciences
In this episode, Olivia Friett, editor of Medical Plastics News, is joined by John Kawola, CEO of Boston Micro Fabrication (BMF), to discuss the importance of 3D printing in the medical sector. Read more
23 Jul 2024
Shutterstock
Menopause in the Spotlight: Balancing awareness and the risk of over-medicalisation
Menopause has finally emerged from the shadows of taboo and silence. This newfound openness is a welcome change, as it encourages a more comprehensive understanding of women’s health and the challenges that come with menopause. Read more
22 Jul 2024
Marbury/Shutterstock
NHS is ‘frittering away’ huge sums on poor purchasing decisions
Chris Whitehouse, a political consultant and expert on medical technology policy and regulation at Whitehouse Communications looks at the impact of delays in the introduction of value-based procurement. Read more
2 Apr 2024
SFIO CRACHO / shutterstock.com
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
Wilmington Healthcare
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
Mascha Tace / Shutterstock.com
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
Sponsored
rh2010_Adobe Stock
Austria: An attractive research centre
Medical technology is one of the most innovative sectors in a time that is not exactly lacking in technological developments. Austria occupies an internationally recognised position in this field. Read more
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White Paper
Medical device regulations: a step forward for patient safety or a step backwards for innovation?
How medical device registries can promote both safety and innovation in a new regulatory landscape. Read more
Sponsored
rh2010_Adobe Stock
Austria: An attractive research centre
Medical technology is one of the most innovative sectors in a time that is not exactly lacking in technological developments. Austria occupies an internationally recognised position in this field. Read more
MedTalk Podcast
Using 3D printing in life sciences
In this episode, Olivia Friett, editor of Medical Plastics News, is joined by John Kawola, CEO of Boston Micro Fabrication (BMF), to discuss the importance of 3D printing in the medical sector. Read more
Sponsored
rh2010_Adobe Stock
Austria: An attractive research centre
Medical technology is one of the most innovative sectors in a time that is not exactly lacking in technological developments. Austria occupies an internationally recognised position in this field. Read more
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Surtex Instruments
14 Nov 2023
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