Medtech Regulatory Insights
Why EU MDR changes are only the beginning – and firms should ensure IFU compliance now
Bob Tilling, VP global sales at Kallik, explains how medical device manufacturers can recover lost time in preparing for EU MDR labelling and IFU compliance – and make sure they are better positioned for other regulations which are bound to follow. Read more
26 Jan 2021
Keep pace with the constantly changing regulatory environment – the Brexit impact
Matija Rupnik, regulatory affairs manager at ArrowFast emphasises the importance of keeping pace with always-changing regulatory landscapes on medical device markets. Read more
1 Dec 2020
Medicines and Medical Devices bill - a new model for UK life sciences?
Richard Coxon, director, life sciences, Dassault Systèmes, examines the potential ramifications of the UK’s Medicines and Medical Devices bill. Read more
11 Dec 2020
Simon Dewhurst
Track and trace: The changes afoot for producing and packaging products
Jeff Jones, coding and tracking business manager at Sewtec Automation, explains the historic use of UDIs and what changes set to come into effect next year are likely to mean for the production and packaging of the industry's products. Read more
23 Dec 2020
Thereapeutic device for migraine treatment granted FDA clearance
Theranica, a prescribed digital therapeutics (PDT) company, has announced its Nerivio therapeutic device has received the Food and Drug Administration clearance to market for an expanded indication for acute treatment of episodic or chronic migraine. Read more
26 Jan 2021
Life science firms encouraged to act now over EU trade with government videos
New on-demand videos are available for life sciences businesses in a drive to encourage them to act now and follow the new rules agreed as part of the UK’s trade agreement with the EU. Read more
26 Jan 2021
Medical device cybersecurity solutions provider receives SOC and ISO certifications
TRIMEDX, a provider of clinical engineering, medical device cybersecurity and clinical asset management solutions to healthcare systems, has successfully achieved the Service Organization Control (SOC) 2 Type 2 certification for its solutions. Read more
25 Jan 2021
Boston Scientific receives FDA clearance for fourth-gen DBS system
Boston Scientific has received Food and Drug Administration (FDA) approval of its fourth-generation Vercise Genus Deep Brain Stimulation (DBS) System. Read more
25 Jan 2021
Why EU MDR changes are only the beginning – and firms should ensure IFU compliance now
Bob Tilling, VP global sales at Kallik, explains how medical device manufacturers can recover lost time in preparing for EU MDR labelling and IFU compliance – and make sure they are better positioned for other regulations which are bound to follow. Read more
26 Jan 2021
Q&A: The smartphone blood test offering rapid COVID-19 screening
Med-Tech Innovation News caught up with healthtech entrepreneur Steve Roest, CEO and co-founder of PocDoc to discuss the company’s smartphone blood tests and recent backing by the DigitalHealth.London accelerator. Read more
26 Jan 2021
2020 hit mental health hard - in 2021 we must break barriers
Oliver Harrison, founder and CEO of Koa Health, explores how 2020 hit our mental health hard and the barriers we must break down in 2021 to deal with the mental health repercussions of the previous year. Read more
22 Jan 2021
yanyong
Encoders: Why they’re used and how to make your selection
Encoders provide feedback for accurate motor control relating to speed and positioning. Chris Schaefer, applications engineer at Portescap, looks at the technologies involved and explains how to choose the encoder for your application. Read more
20 Jan 2021
Vision system featuring laser displacement tech launched
Cognex Corporation has introduced the In-Sight 3D-L4000 embedded vision system. Featuring 3D laser displacement technology, this smart camera allows engineers to solve a range of inspections on automated production lines. Read more
19 Jan 2021
Medicines and Medical Devices bill - a new model for UK life sciences?
Richard Coxon, director, life sciences, Dassault Systèmes, examines the potential ramifications of the UK’s Medicines and Medical Devices bill. Read more
11 Dec 2020
How digital health firms can mitigate risk
Marta Dunphy-Moriel, partner, and Judit Garrido-Fontova, associates at Kemp Little, a London law firm, look at the types of technical risk that can affect digital health businesses. Read more
30 Nov 2020
Q&A: Sepsis detection technology that can triage COVID-19 patients
Ian Bolland caught up with Dr. Rolland Carlson, CEO of Immunexpress, to talk about a molecular diagnostic, SeptiCyte RAPID, which is used to detect sepsis and offers the potential to triage severe COVID-19 patients in the emergency department. Read more
2 Oct 2020
How WIBA UK has assisted manufacturing firm in PPE production
WIBA UK technology has been helping ISO 13485 qualified injection moulder Thornbury Manufacturing Limited (TML) produce COVID-fighting PPE equipment. Read more
15 Jan 2021
Q&A: How particle-based simulators can aid contact tracing
Med-Tech Innovation News spoke to Aknur Karabay, research assistant at the Institute of Smart Systems and Artificial Intelligence at Nazarbayev University. Read more
13 Jan 2021
PLASTIQUE/ PAGE ONE PLASTIQUE
Why cleanrooms have thrived during the pandemic
Todd McDonald, director of sales & marketing at TEQ, explains why there has been an increased demand for cleanroom use during the COVID-19 pandemic. Read more
12 Jan 2021
2020 hit mental health hard - in 2021 we must break barriers
Oliver Harrison, founder and CEO of Koa Health, explores how 2020 hit our mental health hard and the barriers we must break down in 2021 to deal with the mental health repercussions of the previous year. Read more
22 Jan 2021
Why we must demand more transparency from healthtech
Dr Owain Rhys Hughes, former NHS surgeon and CEO of Cinapsis, explores why healthtech companies refusing to acknowledge the role they play in care delivery creates a range of security and clinical concerns for the NHS and its patients. Read more
14 Jan 2021
The rise of person-centred technology-enabled care
Balint Bene, CEO and founder of bene : studio examines the importance of person-centred technology and preventative health solutions. Read more
22 Dec 2020
Q&A: The smartphone blood test offering rapid COVID-19 screening
Med-Tech Innovation News caught up with healthtech entrepreneur Steve Roest, CEO and co-founder of PocDoc to discuss the company’s smartphone blood tests and recent backing by the DigitalHealth.London accelerator. Read more
26 Jan 2021
How linear motion systems can lead to better performing diagnostic equipment
In order for medical facilities to deliver the most accurate and efficient care possible, engineers who design diagnostic and laboratory equipment need to take every detail into account. Read more
7 Jan 2021
How graphene diagnostics tests could transform healthcare
John Tingay, CTO, Paragraf, explains how a test capable of providing diagnostic information on the spot within minutes could transform healthcare provision for both patients and professionals alike. Read more
23 Dec 2020
Virtual becomes reality: Compamed-Medica 2020 preview
Like everything else this year, trade shows have faced disruption thanks to the COVID-19 pandemic. Read more
9 Dec 2020
The effect of lockdown on mental health, and how VR can help
Dr Nigel Whittle, head of medical & healthcare at design and engineering consultancy Plextek, looks at the devastating effects of lockdown on mental health and considers the varying uses of VR technology. Read more
9 Dec 2020
How virtual reality is aiding mental healthcare
Dr Wendy Powell, senior member of the IEEE and associate professor in the Department of Cognitive Science and Artificial Intelligence at Tilburg University, about the specific benefits of VR in mental healthcare. Read more
28 Oct 2020
Healthtech and the pandemic: bigger appetite, but smaller stomachs are stifling innovation
Michael Niddam, managing partner Kamet Ventures, examines the disconnect between the growing demand for innovation in healthcare and the capacity of institutions, organisations, and systems to adopt and integrate that innovation. Read more
23 Dec 2020
AI: The future of pain assessment
Professor Jeff Hughes, chief scientific officer at PainChek, explains how artificial intelligence (AI) and smart automation has the potential to revolutionise pain assessment in patients with dementia who struggle to communicate. Read more
22 Dec 2020
The future of healthcare: a marriage of AI and edge
Nick Offin, head of sales, marketing & operations at dynabook Europe, exploring how technologies like artificial intelligence (AI) and edge computing will power the next phase of healthcare innovation. Read more
18 Dec 2020
