Medtech Regulatory News
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MedTech Europe calls for reform of European regulatory framework
Together with 34 national associations, MedTech Europe has sent an open letter to the European commissioner for Health, Stella Kyriakides, calling for comprehensive structural reform in the European regulatory framework for medical technologies. Read more
18 Sep 2023
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IMed launches guide to market entry in EU, UK and USA
IMed Consultancy has launched a guide to market entry looking at the EU, the UK and the USA. Read more
4 Sep 2023
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TÜV Rheinland grants GaleMed EU MDR certification
TÜV Rheinland has granted Taiwanese medical device manufacturer GaleMed certification in accordance with the new EU Medical Devices Regulation (MDR). GaleMed produces respiratory care interface technology such as neonatal and prenatal ventilation. Read more
31 Aug 2023
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Intertek becomes latest UK medical device approved body
Intertek, a quality assurance provider to industries worldwide, has announced that Intertek Medical Notified Body UK Ltd has been designated against the UK Medical Devices Regulations 2002 by the MHRA. Read more
24 Aug 2023
TÜV SÜD designated UK Approved Body for medical devices
TÜV SÜD has secured designation as a UK Approved Body (UKAB) for medical devices, providing UKCA and CE certification for medical device manufacturers. Read more
15 Aug 2023
![Evie-3XRings-Polished_Shadow[2][2][5][18] copy.png](https://www.med-technews.com/downloads/8912/download/Evie-3XRings-Polished_Shadow%5B2%5D%5B2%5D%5B5%5D%5B18%5D%20copy.png?cb=86a6c66bb4bac0f09dbb73462c84c095&w=640 "Evie-3XRings-Polished_Shadow[2][2][5][18] copy.png")
Movano submits first FDA filing for Evie Ring
Movano Health, a healthcare solutions company at the intersection of medical and consumer devices and makers of the Evie Ring, has submitted a 510(k) premarket notification to the FDA for the company’s first commercial product, the Evie Ring. Read more
3 Aug 2023
![Evie-3XRings-Polished_Shadow[2][2][5][18] copy.png](https://www.med-technews.com/downloads/8912/download/Evie-3XRings-Polished_Shadow%5B2%5D%5B2%5D%5B5%5D%5B18%5D%20copy.png?cb=86a6c66bb4bac0f09dbb73462c84c095&w={width}&h={height} "Evie-3XRings-Polished_Shadow[2][2][5][18] copy.png")
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How AI and machine learning can revolutionise labelling software
Gurdip Singh, CEO of Kallik, discusses how AI and machine learning can be incorporated into labelling and artwork management software to prevent errors, enhance the user experience and give companies a competitive advantage. Read more
13 Sep 2023
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Value-based procurement: turning idea into reality
Chris Whitehouse, a political consultant and expert on medical technology policy and regulation at Whitehouse Communications and chair of the Urology Trade Association updates readers on value-based procurement. Read more
6 Sep 2023
The essentials for cybersecurity of medical devices
Joe Lomako, business development manager (IoT) at TÜV SÜD, outlines key regulatory considerations regarding cybersecurity. Read more
23 Aug 2023
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Three key questions for the government following safety mark upheaval
William Lee, head of policy at the British Healthcare Trades Association (BHTA), outlines three key questions for the Government on behalf of the healthcare manufacturing sector to deliver the future of medical device regulation in the UK. Read more
17 Aug 2023
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Post-Brexit regulation - empowering the MHRA
Chris Whitehouse, a political consultant and expert on medical technology policy updates readers on the MHRA and post-Brexit regulation. Read more
1 Aug 2023
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The NHS medtech strategy: how is it playing out?
Oli Hudson, content director at Wilmington Healthcare, looks at the NHS’s flagship medtech policy and what industry should read into it. Read more
![HCA Photo High Res[58] copy.jpg](https://www.med-technews.com/downloads/9118/download/HCA%20Photo%20High%20Res%5B58%5D%20copy.jpg?cb=aa6680cb655658a4edc70f8e3eb08618&w=640 "HCA Photo High Res[58] copy.jpg")
ABHI US Accelerator 2024 application deadline approaching
The Association of British HealthTech Industries (ABHI) has announced that applications for the ABHI US Accelerator 2024 cohort are closing in mid-October – with nearly 50% of places taken already. Read more
22 Sep 2023
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Natural Cycles receives clearance to integrate with Apple Watch
Natural Cycles, the company that developed the world’s first birth control app, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its use of wrist temperature data from Apple Watch. Read more
22 Sep 2023
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International Regulatory Pathways project brings digital health experts
DiMe has assembled a global team of digital health experts, including S3 Connected Health, to support digital health product developers in pursuing and optimising their strategies. Read more
21 Sep 2023
![LTH Helen Ford[36] copy.jpg](https://www.med-technews.com/downloads/9111/download/LTH%20Helen%20Ford%5B36%5D%20copy.jpg?cb=39926f1ddd0ceef0c31fbaf9d7ab894a&w=640 "LTH Helen Ford[36] copy.jpg")
New motion detection tool aims to identify Multiple Sclerosis treatments
Clinicians and researchers at Leeds Teaching Hospitals NHS Trust have invented a new motion detection tool to help identify treatments for progressive multiple sclerosis and other neurodegenerative conditions. Read more
21 Sep 2023
Bruntwood SciTech begins work on £42m space in Manchester
Bruntwood SciTech has commenced construction on a £42 million, 125,000 sq ft specialist lab and office workspace at the Citylabs cluster to strengthen the health innovation campus. Read more
20 Sep 2023
![HCA Photo High Res[58] copy.jpg](https://www.med-technews.com/downloads/9118/download/HCA%20Photo%20High%20Res%5B58%5D%20copy.jpg?cb=aa6680cb655658a4edc70f8e3eb08618&w={width}&h={height} "HCA Photo High Res[58] copy.jpg")
![LTH Helen Ford[36] copy.jpg](https://www.med-technews.com/downloads/9111/download/LTH%20Helen%20Ford%5B36%5D%20copy.jpg?cb=39926f1ddd0ceef0c31fbaf9d7ab894a&w={width}&h={height} "LTH Helen Ford[36] copy.jpg")
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Biowearables: Evolution and potential
Marc Taub, PhD, divisional vice president of technical operations for Abbott's diabetes care business, shares his thoughts on the use and potential of biowearables, the latest evolution of health technology. Read more
21 Sep 2023
![OBDS device on patient[90] copy.png](https://www.med-technews.com/downloads/9100/download/OBDS%20device%20on%20patient%5B90%5D%20copy.png?cb=0d803cdf9874b15eb535348bac2f4218&w=640 "OBDS device on patient[90] copy.png")
Close to the body: Standard-compliant testing of wearable autoinjectors
Alan Thomas, marketing at ZwickRoell, analyses the mechanical testing of wearable autoinjectors for drug delivery devices. Read more
20 Sep 2023
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Injection moulding of thin wall cannulas: A lesson in expertise and persistence
Paul Runyan, VP of sales, Accumold, explains how the company can successfully micro injection mould thin wall cannulas at volume. Read more
20 Sep 2023
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Tips and tricks for user-centric design
Leanne Yip, head of design and usability at Springboard, a product research and design consultancy, outlines some tips and tricks for designing patient-centric medical devices. Read more
19 Sep 2023
![OBDS device on patient[90] copy.png](https://www.med-technews.com/downloads/9100/download/OBDS%20device%20on%20patient%5B90%5D%20copy.png?cb=0d803cdf9874b15eb535348bac2f4218&w={width}&h={height} "OBDS device on patient[90] copy.png")
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Unveiling the lessons of the femtech revolution
Shada Azodi, research director, Bold Insight outlines why femtech should be investing more into user experience research. Read more
21 Sep 2023
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How AI and machine learning can revolutionise labelling software
Gurdip Singh, CEO of Kallik, discusses how AI and machine learning can be incorporated into labelling and artwork management software to prevent errors, enhance the user experience and give companies a competitive advantage. Read more
13 Sep 2023
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The UK rejoining Horizon: A welcome, grown-up step
Ian Bolland offers his reaction to the UK rejoining Horizon. Read more
8 Sep 2023
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Three key questions for the government following safety mark upheaval
William Lee, head of policy at the British Healthcare Trades Association (BHTA), outlines three key questions for the Government on behalf of the healthcare manufacturing sector to deliver the future of medical device regulation in the UK. Read more
17 Aug 2023
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State of IoT adoption for healthcare and medical devices
IoT in healthcare is finally coming of age. Innovative organisations are embracing IoT and seeing tangible business benefits. But adoption is not without its challenges. Read more
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The NHS medtech strategy: how is it playing out?
Oli Hudson, content director at Wilmington Healthcare, looks at the NHS’s flagship medtech policy and what industry should read into it. Read more
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The business and medical case
Olivia Friett, editor of Medical Plastics News, is joined by Konrad Brodaczewski and Dr Andrzej Decewicz from Grena, as they discuss both the business and medical aspects of developing medical devices and bringing them to market. Read more
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What’s next? A peek into the near future of polymer-based solutions
For more than 70 years, polymer specialist Raumedic has partnered with companies and practitioners to develop solutions for medical and pharmaceutical applications. Read more
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12 May 2023
