Medtech Regulatory News
EMMA International and THEMA enter strategic partnership
EMMA International has entered a strategic partnership with THEMA, an Italian based strategic-regulatory consulting company focused on medical and IVD devices. Read more
26 Jan 2023
Mindray receives MDR clearance for defibrillators
Medical device provider Mindray has received certification for its defibrillators, under the European Union's newest Medical Device Regulation (MDR). Read more
18 Jan 2023
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MTD Group receives FDA clearance for passive safety needle
MTD Group has announced FDA clearance obtained by its affiliate Pikdare S.p.A. for DropSafe Sicura passive safety needle, an injection needle with a fully passive mechanism that can be used for the intramuscular and subcutaneous injection. Read more
13 Jan 2023
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Penumbra's new Lightning Flash system cleared by FDA
Penumbra has received U.S. Food and Drug Administration (FDA) clearance and launched Lightning Flash, a mechanical thrombectomy system. Read more
12 Jan 2023
Hand-out Ultromics
Ultromics receives FDA clearance for AI diagnostic for heart failure
Ultromics' EchoGo Heart Failure, an AI solution for echocardiography for the diagnosis of heart failure with preserved ejection fraction (HFpEF), has received US Food and Drug Administration (FDA) clearance. Read more
12 Dec 2022
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BIOCORP's Mallya device receives FDA 510(k) clearance
BIOCORP, a French company specialised in the design, development, and manufacturing of medical devices, has received 510(K) clearance from the FDA to market Mallya, its smart medical device that connects insulin pens. Read more
8 Dec 2022
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A look at the FDA’s approach to medical device regulations
Chris Harvey, senior vice president of brand protection at Sedgwick, discusses the recall data in the company’s Brand Protection report. Read more
20 Jan 2023
Making social value real in the health sector
Jin Sahota and Alan Wain, who have over 20 years' experience in public procurement, address the critical topic of social value. Read more
16 Jan 2023
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2023: out with the old, in with the new?
Chris Whitehouse, a political consultant and expert on medical technology policy and regulation at Whitehouse Communications, chair of the Urology Trade Association updates readers on key recent announcements impacting the medtech sector in the UK. Read more
6 Jan 2023
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Proposed revisions to the MDR – what will these mean in practice
Elizabeth Anne Wright, partner, and Anastasia Vernikou, legal trainee, at law firm Cooley explain the practicalities of any proposed revision to the EU Medical Device Regulation (MDR). Read more
16 Dec 2022
Securing 40 patents in four years: Navigating the IP landscape
Robert Donald, innovation and licensing officer at Medovate explains how the company navigates the IP landscape having secured 40 patents in four years. Read more
24 Nov 2022
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11 key quality regulation terms to know post-Brexit
Are you a quality manager for a small medical device start-up looking to expand into global markets? Or maybe you are a seasoned device manufacturer preparing to once again traverse quality regulations to deliver a new product to the European market? Read more
Natwest and PHTA partner to boost life sciences entrepreneurship
NatWest and the Precision Health Technologies Accelerator (PHTA) are partnering to boost entrepreneurship in the health and life sciences sectors, with the aim of supporting the growth of the sectors across the West Midlands. Read more
27 Jan 2023
Blackford Analysis to be acquired by Bayer
Blackford Analysis, a strategic imaging Artificial Intelligence (AI) platform and solutions provider, will be acquired by Bayer, a global life science company. Read more
26 Jan 2023
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Nominations open for 2023 Prix Galien UK Awards
The Galien Foundation has announced that nominations for the 2023 Prix Galien UK Awards are now open. Read more
26 Jan 2023
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TISSIUM appoints Dr. Alex Milstein as chief medical officer
TISSIUM, a privately-owned medical technology company developing a portfolio of biomorphic programmable polymers for tissue reconstruction, has appointed Dr. Alex Milstein as its chief medical officer. Read more
26 Jan 2023
EMMA International and THEMA enter strategic partnership
EMMA International has entered a strategic partnership with THEMA, an Italian based strategic-regulatory consulting company focused on medical and IVD devices. Read more
26 Jan 2023
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How can the UK seize the initiative for healthcare partnerships with the Gulf?
Michael Latham, associate director, Lexington, explains why feels the future of medtech innovation depends on UK-Arab trade relationships. Read more
27 Jan 2023
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Using technology to keep people out of hospital
Sonia Neary from Wellola discusses the appetite for technology for treating conditions, how to keep people out of hospital if possible, the current backlogs being seen by health services and diversity challenges in healthcare. Read more
27 Jan 2023
Calibration: Testing times for instrument accuracy
Andrew Simpson, business development manager for Calibrationhouse, explains the importance of maintaining the measurement accuracy of test instruments. Read more
26 Jan 2023
Ken Lin
Cobot assistant: The latest solution for medical device manufacturing
Industry 5.0 and a greater focus on user-friendliness make robotics more attractive for inspection, materials transport, and other tasks. Read more
24 Jan 2023
grandbrothers / shutterstock.com
A look at the FDA’s approach to medical device regulations
Chris Harvey, senior vice president of brand protection at Sedgwick, discusses the recall data in the company’s Brand Protection report. Read more
20 Jan 2023
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MedTechs need a platform that enables their developers’ talents to blossom
Mike Fuller, regional director of marketing, InterSystems UKI, outlines research suggesting developers could instead be better spending their time working on driving their end products to market, rather than getting caught up in menial data tasks. Read more
17 Jan 2023
Making social value real in the health sector
Jin Sahota and Alan Wain, who have over 20 years' experience in public procurement, address the critical topic of social value. Read more
16 Jan 2023
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Patient experience is key to harnessing the benefits of medical technology
Barbara Harpham, chair of the Medical Technology Group, writes about the importance of involving patients in the implementation and use of medical technology in different healthcare settings. Read more
16 Jan 2023
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Danai Jetawattana Danai - stock.adobe.com
11 key quality regulation terms to know post-Brexit
Are you a quality manager for a small medical device start-up looking to expand into global markets? Or maybe you are a seasoned device manufacturer preparing to once again traverse quality regulations to deliver a new product to the European market? Read more
ProStockStudio Shutterstock
Using technology to keep people out of hospital
Sonia Neary from Wellola discusses the appetite for technology for treating conditions, how to keep people out of hospital if possible, the current backlogs being seen by health services and diversity challenges in healthcare. Read more
Sponsored
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