Medtech Regulatory News
Align Technology receives Class IIa certification for Invisalign system
Align Technology, a medical device company that designer and manufacturer has seen its Invisalign system and Vivera retainers certified by the European Union as Class lla medical devices. Read more
5 Oct 2021
RQM+ creates filtering tool for easier MDR navigation
RQM+ has created a tool that allows users to search the legislation for specific subject areas, to allow for easier navigation of the EU Medical Device Regulation (MDR). Read more
20 Oct 2021
Webinar to update current changes to MDR and IVDR
Medilink Midlands will cover an update on the current changes to Medical Device Regulation (MDR), In Vitro Diagnostic Regulation (IVDR) and the role of the person responsible. Read more
14 Oct 2021
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Alpha-radiation cancer therapy receives further FDA Breakthrough designation
Alpha Tau Medical, the developer of the alpha-radiation cancer therapy Alpha DaRT, has received Breakthrough Device Designation for Alpha DaRT from the U.S. Food and Drug Administration (FDA) for the treatment of patients with recurrent GBM. Read more
12 Oct 2021
SyncThink receives further FDA clearance for concussion aid
SyncThink, a neurotechnology company and developer of the EYE-SYNC technology, has received clearance from the Food and Drug Administration (FDA) for the EYE-SYNC technology as an aid to concussion, or mild Traumatic Brain Injury (mTBI) Diagnosis. Read more
8 Oct 2021
Webinar to consider current post-Brexit situation in life sciences
Medilink Midlands will be hosting a webinar with Mills & Reeve to consider the situation in life sciences ten months on after the implementation of the UK’s Brexit deal with the EU. Read more
8 Oct 2021
Technology to the fore as regulations tighten
Bob Tilling, VP global sales at Kallik draws on over two decades of industry experience to discuss the evolution of medical device trends, technology and regulation; and how digital platforms will be increasingly critical to navigate what lies ahead. Read more
21 Oct 2021
Guarding against the fraud risks brought about from COVID-19
Sam Roberts, partner, and Elizabeth Meade, senior associate, at law firm Cooke, Young and Keidan, explores the fraud risks the COVID-19 pandemic has opened up in the medtech space, and the steps that companies can take to protect themselves legally. Read more
19 Oct 2021
Q&A: How a QMS can lead to quicker medical device launches
Robert Fenton, founder and CEO of Qualio, explains to Med-Tech Innovation News how its quality management system can help medical device companies launch their products faster. Read more
24 Sep 2021
UKCA mark: The practicalities
Itoro Udofia, director, Medical Health Service at TÜV SÜD, a global product testing and certification organisation, explains what you need to know about the UKCA mark. Read more
15 Sep 2021
Tracking down 48,000 malfunctioning pacemakers
Joan Melendez, founder and president of Xcelrate UDI, explains how UDI tracking can help going about tracking devices down that have been recalled. Read more
13 Sep 2021
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Bio-Rad Laboratories launches new real-time PCR detection systems
Bio-Rad Laboratories, a life science research and clinical diagnostic specialist, has launched the CFX Opus 96 Dx System and the CFX Opus 384 Dx System, real-time PCR detection systems that have been listed with the FDA for IVD testing. Read more
25 Oct 2021
Healthtech firm wins £500k funding boost for medication adherence tech
A Lancashire healthtech firm has won a £500,000 funding boost to develop its technology that helps patients better manage their medicines in their own homes. Read more
25 Oct 2021
AI-powered 'Test-To-Go' system receives CE mark
Clinical AI company Sensyne Health’s licence and development partner, Excalibur Healthcare Services, has received European regulatory certification, which includes the UK, for its ‘Test-To-Go’ COVID-19 antigen testing system. Read more
22 Oct 2021
CorWave receives 2021 HealthTech Award in medtech
CorWave, a French medtech company developing a next generation heart pump, won the 2021 HealthTech Award in the Medtech category yesterday. Read more
22 Oct 2021
Project examining bioelectrical tech for pain management announced
A new clinical project to examine the effects of the use of bioelectrical technology for pain management in patients waiting for knee replacement surgery will launch this month. Read more
22 Oct 2021
Opportunity to learn about Ireland's medtech capabilities at Med in Ireland
UK healthcare providers and medtech industry professionals have a unique opportunity to learn more about Ireland’s medtech capabilities and tap into the ecosystem that has elevated it to a position as one of the world’s leading hubs for the industry. Read more
22 Oct 2021
Advice from the NIHR to budding life science start-ups
In this episode we hear from Alex Menys, CEO and founder of Motilent, a company that has been guided by the NIHR; Ian Newington, head of special projects at the NIHR to explain how the organisation works with start-ups. Read more
20 Oct 2021
Q&A: Developing a smart test for a range of conditions
Med-Tech Innovation News caught up with Angelica Kohlmann, co-founder of Bloom Diagnostics, to talk about its technology that can help detect a range of medical conditions. Read more
15 Oct 2021
Cognetivity agrees to deploy cognitive assessment at NHS mental health Trust
Cognetivity Neurosciences has finalised a commercial agreement with Birmingham and Solihull Mental Health NHS Foundation Trust (BSMHFT) to deploy its Integrated Cognitive Assessment (ICA) across both primary and secondary care. Read more
7 Oct 2021
The impact of aesthetics on product design
Sean Hägen, founding principal, BlackHägen Design, considers the nuances in the aesthetics of medical device design. Read more
25 Oct 2021
Technology to the fore as regulations tighten
Bob Tilling, VP global sales at Kallik draws on over two decades of industry experience to discuss the evolution of medical device trends, technology and regulation; and how digital platforms will be increasingly critical to navigate what lies ahead. Read more
21 Oct 2021
Guarding against the fraud risks brought about from COVID-19
Sam Roberts, partner, and Elizabeth Meade, senior associate, at law firm Cooke, Young and Keidan, explores the fraud risks the COVID-19 pandemic has opened up in the medtech space, and the steps that companies can take to protect themselves legally. Read more
19 Oct 2021
Do no harm: Securing wireless medical devices
Emmanuel Sambuis, senior marketing director, head of portable medical devices at Silicon Labs, examines growing threats and how to guard against them. Read more
18 Oct 2021
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Webinar
WEBINAR: How suppliers can support MDR compliance for your medical devices
In this webinar, Thomas Beck and Lee Ferguson discuss Emerson’s solution partner approach and the way they are prepared to support with expertise, infrastructure, and processes. Read more
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Advice from the NIHR to budding life science start-ups
In this episode we hear from Alex Menys, CEO and founder of Motilent, a company that has been guided by the NIHR; Ian Newington, head of special projects at the NIHR to explain how the organisation works with start-ups. Read more
Sponsored
Opportunity to learn about Ireland's medtech capabilities at Med in Ireland
UK healthcare providers and medtech industry professionals have a unique opportunity to learn more about Ireland’s medtech capabilities and tap into the ecosystem that has elevated it to a position as one of the world’s leading hubs for the industry. Read more
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