Medtech Regulatory News
NICE to approve changes for NHS technology evaluation
Changes to the way medicines and other health technologies are evaluated for use in the NHS are expected to be approved by the NICE Board today. Read more
19 Jan 2022
RQM+ acquires regulatory affairs player AcKnowledge RS
RQM+, a provider of regulatory, quality, and clinical consulting services for medical device and IVD manufacturers, has acquired AcKnowledge RS, a San Diego-based firm specialising in regulatory affairs consulting. Read more
6 Jan 2022
MedTech Europe welcomes proposal to amend IVDR transitional provisions
MedTech Europe has welcomed the adoption of the European Commission’s Proposal to amend the transitional provisions of the new EU In Vitro Diagnostic Medical Devices Regulation (IVD Regulation). Read more
5 Jan 2022
FDA grants Breakthrough Designation to intestinal management system
Medical device company USMIMA S.L. (brand name MOWOOT), with headquarters in Barcelona, has announced that its first product “MOWOOT II Intestinal Transit Management System” has been granted Breakthrough Device Designation by the FDA. Read more
5 Jan 2022
Manus receives FDA Breakthrough Designation for NMP device
Manus Neurodynamica, which develops and markets products and technologies for neuromotor assessment, has been granted Breakthrough Designation by the U.S. Food and Drug Administration (FDA) for its NeuroMotor Pen (NMP) device. Read more
4 Jan 2022
White paper highlights clinical evidence required for IVDR
A white paper from RQM+, the regulatory, quality, and clinical consulting firm, aims to provide clarity on the clinical evidence required to comply with the EU IVDR, and spotlights synergies between EU and US requirements. Read more
4 Jan 2022
Early stage patent strategy considerations for femtech start-ups
Maisy Leung, associate at EIP and Rosie McDowell, associate at EIP, take you through the legal implications that entrepreneurs need to consider when bringing their product to market. Read more
19 Jan 2022
MHRA consultation: Considering the UK's regulatory landscape
Professor James Moore, Department of Bioengineering, Imperial College London, provides some insight on the considerations the MHRA will have when developing the UK’s medical device regulatory pathway. Read more
4 Jan 2022
Are regulations keeping pace with femtech?
Sophie McGrath, partner at Goodwin, considers whether the regulatory environment surrounding women’s health and femtech devices are fit for purpose. Read more
21 Dec 2021
Too much too soon? Filing IP and patent applications
Chris Froud and Alexander Ford, senior associates and patent attorneys at European intellectual property firm, Withers & Rogers, explain why there is such a thing as filing IP and patent applications too early. Read more
27 Dec 2021
Regulation & application: bringing devices to market
Rachel Fallon, CTO Sky Medical, outlines the challenges and regulatory hurdles faced when adopting medtech devices into global healthcare systems. Read more
21 Dec 2021
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The impact of new European Medical Device Regulations
The New Regulation (EU) 2017/745 for medical devices (MDRs), which went into effect on May 26, 2021, is a major update to the regulatory framework in the European Union (EU). Read more
TensCare to showcase latest pain relief devices at Arab Health
TensCare – a manufacturer and distributor of TENS machines – will be joining the ABHI UK Pavilion at Arab Health 2022 to showcase its latest products in pain relief and electro-therapy. Read more
21 Jan 2022
Huma buys digital health firm iPLATO Healthcare
Huma has bought iPLATO Healthcare, whose patient engagement software covers a network of 26.6 million patients across nearly 3,000 NHS primary care organisations and whose myGP app is one of the most downloaded medical apps in the UK. Read more
20 Jan 2022
P3 Medical to showcase device making mechanical ventilation safer
P3 Medical – a UK distributor for several international medical device manufacturers – is set to showcase a device designed to tighten infection control in airway management at Arab Health 2022. Read more
20 Jan 2022
Beckman Coulter receives EU QMS certificate under IVDR for 200+ reagents
Beckman Coulter Life Sciences has received a EU Quality Management System Certificate under the new In Vitro Diagnostic Medical Devices Regulation (IVDR) for more than 200 flow cytometry reagents. Read more
20 Jan 2022
Forresters partners with TBAT to support SME innovation challenge
Forresters has partnered with TBAT Innovation to provide IP support to SMEs looking to innovate. Read more
20 Jan 2022
Early stage patent strategy considerations for femtech start-ups
Maisy Leung, associate at EIP and Rosie McDowell, associate at EIP, take you through the legal implications that entrepreneurs need to consider when bringing their product to market. Read more
19 Jan 2022
Killing germs inside you, on you and around you
Corrine Lawrence and Caroline Jackson from Medical Plastics News are joined by Arjun Luthra, commercial director of BioInteractions to discuss its infection prevention technology and its efforts to be adopted by the UK government. Read more
11 Jan 2022
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The Journey from ‘Art to Part’ …and how to avoid the many pitfalls
Graham Webster, director at Plastic-IT, discusses the injection moulding route on making a high-quality part for medical devices. Read more
22 Dec 2021
Regulation & application: bringing devices to market
Rachel Fallon, CTO Sky Medical, outlines the challenges and regulatory hurdles faced when adopting medtech devices into global healthcare systems. Read more
21 Dec 2021
Virtual testing of cardiovascular devices – improving patient outcomes
Jessica James, business process analyst at the Synopsys Simpleware Product Group, explains recent innovations in using virtual testing and AI to optimise cardiovascular medical devices. Read more
21 Jan 2022
The reality of frontline innovators delivering pioneering transformation
A conversation with Uday Bose, country managing director and head of human pharma at Boehringer Ingelheim UK & Ireland. Read more
20 Jan 2022
Q&A: PrecisionPoint: A safer approach to biopsy?
Med-Tech Innovation News spoke to Dr. Matthew J Allaway, a urologist at Urology Associates in Maryland and designer of the PrecisionPoint system in a bid to provide a safer approach to biopsy. Read more
18 Jan 2022
What comes next for healthcare? 2022 predictions
There’s no question that the healthcare sector has faced two years of extreme difficulty. The need to treat an influx of virus cases, whilst still maintaining other essential services, has put unimaginable strain on a system which we all rely on. Read more
14 Jan 2022
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White Paper
How In Silico Medicine Can Accelerate Innovation in Medical Devices
In this white paper Dr. Visa Suomi, Medical Devices Industry Manager at MathWorks, discusses how medtech companies can take advantage of computational modelling and simulation in medical devices R&D and stay competitive in the future Read more
Predicting problems in diagnostics development
With the increased market need for diagnostic devices and the consequent requirement for an expedited development pathway, it is inevitable that many innovations will stumble upon unidentified pitfalls within their development, hindering their route Read more
Sponsored
The impact of new European Medical Device Regulations
The New Regulation (EU) 2017/745 for medical devices (MDRs), which went into effect on May 26, 2021, is a major update to the regulatory framework in the European Union (EU). Read more
Killing germs inside you, on you and around you
Corrine Lawrence and Caroline Jackson from Medical Plastics News are joined by Arjun Luthra, commercial director of BioInteractions to discuss its infection prevention technology and its efforts to be adopted by the UK government. Read more
Sponsored
The impact of new European Medical Device Regulations
The New Regulation (EU) 2017/745 for medical devices (MDRs), which went into effect on May 26, 2021, is a major update to the regulatory framework in the European Union (EU). Read more
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Mikal Ludlow Photography
6 Dec 2021
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22 Nov 2021
