Medtech Regulatory News
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BHTA and BIVDA respond to consultation on UK medical device regulation
The Medicines and Healthcare Products Regulatory Agency has published its response to its consultation on the future of medical devices regulation in the United Kingdom. Read more
28 Jun 2022
Medovate secures approval for SAFIRA in Singapore
Medovate and its Singapore-based distributor Bluestone Corporation Pte have secured Singapore’s Health Sciences Authority (HSA) approval for the SAFIRA (SAFer Injection for Regional Anaesthesia) system. Read more
23 Jun 2022
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Contract manufacturer Plitek obtains ISO 13485 certification
Plitek, a contract converter/manufacturer of precision die cut components and converted materials, has obtained ISO 13485:2016 Certification. Read more
22 Jun 2022
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AMS receives FDA clearance for new wound closure device
Advanced Medical Solutions, a specialist in tissue-healing technologies, has received FDA 510(k) approval for LiquiBand XL, a new device that can close longer wounds than existing LiquiBand products. Read more
6 Jun 2022
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MedTech Europe welcomes application of IVDR
The application of the In Vitro Diagnostic Medical Devices Regulation (IVDR) marks an important new chapter for in vitro diagnostic (IVD) medical tests in Europe. Read more
31 May 2022
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Linear receives clearance for catheter safety release valve
Linear Health Sciences has received U.S. FDA clearance and Health Canada approval of its Orchid SRV, a tension-activated breakaway safety release valve designed to reduce the risk of IV catheter failure and replacement in hospitals. Read more
23 May 2022
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World leading? The future arrangements for medical device regulation
Chris Whitehouse, an expert on medical technology policy and regulation at Whitehouse Communications and chair of the Urology Trade Association, provides his thoughts on the published consultation from the MHRA about UK medical device regulation. Read more
4 Jul 2022
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What standard of care in CRO agreements?
Michael Darowski, partner, McDermott Will & Emery and Derek Safadi, trainee reflect on a recent case as they analyse CRO agreements in clinical trials. Read more
16 Jun 2022
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More AI-based innovation means start-ups can’t afford to ignore IP
Bethan Halliwell and Harry Strange from Withers & Rogers debunk myths about patenting AI systems and algorithms while highlighting some recent examples of patented medtech innovations in areas such as clinical diagnosis and image processing. Read more
23 Jun 2022
Q&A: Why NDAs are still relevant to medtech firms and start-ups
Mauricio Uribe, partner at Knobbe Martens, discusses the effects that NDAs have on medtech inventions, the potential barriers they can create for start-ups and other important information to know, particularly in the USA. Read more
20 Jun 2022
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Patient choices, outcomes and autonomy: Vital factors for new policy
In the latest of a series of articles, Chris Whitehouse, an expert on medical technology policy at Whitehouse Communications, updates readers on changes to medical technology investment, innovation and regulation. Read more
8 Jun 2022
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Intertronics launches new series of wearables adhesives
To help manufacturers of wearable devices adapt to industry trends and customer requirements, adhesives and dispensing equipment specialist Intertronics has introduced the Dymax 2000-MW series of medical wearables adhesives and encapsulants. Read more
1 Jul 2022
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Search begins for digital health solutions to tackle challenges in Wales
A search has begun for digital solutions to the biggest challenges facing the Welsh health and social care sectors today. Read more
5 Jul 2022
Smart Cane receives £1.7m backing from UKRI
WeWALK, the company behind products for visually impaired people, has secured funding for a £1.7 million Designed for Ageing project through UK Research and Innovation (UKRI). Read more
5 Jul 2022
PETER MEDLICOTT
WMAHSN event highlights effect of innovation on NHS
Representatives from NHS England and NHS Improvement attended a two-day event, hosted by the West Midlands Academic Health Science Network (WMAHSN), at iCentrum Birmingham Innovation Campus, on 27-28 June. Read more
4 Jul 2022
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Visby expands Series E round to bring total to $135m
Diagnostic company Visby Medical has expanded its over-subscribed Series E financing round to include an additional $35 million for a total of over $135 million raised in the round. Read more
4 Jul 2022
Martin Shields
SHIL rebrands as InnoScot Health ahead of 20th anniversary
Scottish Health Innovations Limited (SHIL) has been rebranded as InnoScot Health as the organisation prepares to mark its 20th anniversary. Read more
1 Jul 2022
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BD roundtable: The landscape for women in medtech
Caroline Beecham, Theresa Shapland, and Sian Burgess, national clinical manager from BD, share their experiences of moving up the career ladder and discuss the continued change they hope to see in years to come. Read more
29 Jun 2022
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NHS procurement challenges for medtech and the state of the nation
Ian Bolland is joined by Oli Hudson from Wilmington Healthcare, to discuss the procurement challenges medtech companies face, explaining why medtech firms face a 'new NHS' and comments on Wilmington's recently released state of the nation report. Read more
29 Jun 2022
How Emerson's flow-control tech helped BioBusiness fight COVID-19 in Egypt
Moataz Mamdouh, sales manager, Fluid Control Pneumatics at Emerson outlines its role in helping one of its customers develop a ventilator to tackle COVID-19 in Egypt. Read more
28 Jun 2022
Choosing the right test tools for medical device maintenance
Lewis Lennard, application engineer, Rigel Medical examines the ways to choose test tools for medical device maintenance. Read more
27 Jun 2022
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World leading? The future arrangements for medical device regulation
Chris Whitehouse, an expert on medical technology policy and regulation at Whitehouse Communications and chair of the Urology Trade Association, provides his thoughts on the published consultation from the MHRA about UK medical device regulation. Read more
4 Jul 2022
Case study: PDD and Vitalograph's partnership
Jamie Buckley, creative director at PDD explains how the company worked with Vitalograph on the design of the In2itive Spirometer, a handheld, portable device suitable for both adult and paediatric testing. Read more
1 Jul 2022
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How people with multiple medication needs are being left behind
Issa Patel, CEO, CONNECT Care, explores what he feels is a crucial oversight which will have long-term, negative repercussions on the NHS and care providers if not addressed. Read more
30 Jun 2022
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The true value of Human-Centred Research within medical technology
Hollie Johnston, principal and human sciences capability lead at PDD, elaborates on the specifics of Human-Centred Design (HCD), explaining how it can improve patient experience, address shortcomings in innovation and eliminate systemic bias Read more
24 Jun 2022
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Three practical steps to using AI in medical device manufacturing
Undoubtedly, there’s a lot of hype surrounding artificial intelligence (AI). It seems to be in every other headline. There’s no doubt AI has the potential to transform medical device manufacturing. Read more
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The four most important AI trends in the medical technology industry
This white paper from Advantech outlines four key trends to consider in your end-to-end solution to ensure that devices are constantly being adapted to new AI options in an efficient and cost-effective manner. Read more
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Intertronics launches new series of wearables adhesives
To help manufacturers of wearable devices adapt to industry trends and customer requirements, adhesives and dispensing equipment specialist Intertronics has introduced the Dymax 2000-MW series of medical wearables adhesives and encapsulants. Read more
1 Jul 2022
Shutterstock
NHS procurement challenges for medtech and the state of the nation
Ian Bolland is joined by Oli Hudson from Wilmington Healthcare, to discuss the procurement challenges medtech companies face, explaining why medtech firms face a 'new NHS' and comments on Wilmington's recently released state of the nation report. Read more
Sponsored
Three practical steps to using AI in medical device manufacturing
Undoubtedly, there’s a lot of hype surrounding artificial intelligence (AI). It seems to be in every other headline. There’s no doubt AI has the potential to transform medical device manufacturing. Read more
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