Medtech Regulatory News
Neuromodulation treatment for chronic migraine given CE mark
Chordate Medical Holding AB, a Swedish medtech company, has developed and patented an innovative treatment method: K.O.S. The company's existing EC-certificate for K.O.S has now been granted an extension with the indication chronic migraine. Read more
12 May 2021
Report paints positive picture of firms' ability to meet MDR and IVDR deadlines
A research report from RWS, a provider of technology-enabled language, content management and intellectual property services, highlights the impact of COVID-19 on medical device manufacturers, and their readiness to meet MDR and IVDR deadlines. Read more
10 May 2021
Biobeat receives CE mark for AI-powered remote monitoring platform
Biobeat, a wearable remote patient monitoring player has received the CE mark for its full AI-powered wearable remote patient monitoring platform. Read more
6 May 2021
AlgoDx receives CE mark for sepsis device
AlgoDx, a clinical stage medical device software company, has announced obtained the CE mark for NAVOY Sepsis. This medical device is intended to assist medical staff at Intensive Care Units (ICU) to predict sepsis in adult ICU patients. Read more
5 May 2021
Medtronic's Emprint catheter kit receives FDA Breakthrough designation
Medtronic has received Breakthrough Device Designation status from the U.S. Food and Drug Administration (FDA) for the Emprint ablation catheter kit – an investigational device not yet approved or cleared in the United States. Read more
29 Apr 2021
Experts to discuss how firms can proactively manage labelling risk
A group of industry experts is set to explore how medical device, clinical trial and pharmaceutical companies can proactively manage labelling risk. Read more
29 Apr 2021
The opportunities and challenges of AI
Tom Phipps and Jocelyn Ormond, from Ashfords LLP’s healthcare, digital health & life sciences sector group, comment on whether a stronger, more innovate framework is needed to boost closer working together between the NHS and digital health industry. Read more
7 May 2021
Interpreting ISO Standards to streamline testing and submissions
Kimberly Ehman, from WuXi AppTec & Bob Przygoda, from Adventure Biocompatibility Consulting, explain how ISO 10993 Standards impact on biocompatibility evaluations for global submissions. Read more
16 Apr 2021
Turn and face the strange: Adapting to regulatory changes
Ian Bolland caught up with Alan Finnerty, technology director at Medovate, to establish how the company is adapting to a changing regulatory landscape following Brexit. Read more
12 Apr 2021
The UK Medical Device Information System – A new resource for medtechs
Mark Wasmuth the CEO of the GMDN Agency (www.gmdnagency.org/), the international not-for-profit body, explains the functions of the UK Medical Device Information System. Read more
31 Mar 2021
Software as a Medical Device - Demystifying EU MDR
Thomas ET, senior associate, medical devices, Freyr, explains how EU MDR will apply to companies with Software as a Medical Device (SaMD). Read more
22 Mar 2021
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Take to the stage: A preview of Med-Tech Innovation Expo's conference line-up
Med-Tech Innovation’s conference team guide us through what to expect across three stages for September’s show. Read more
ACON's Flowflex test receives CE mark for self-testing
ACON, one of the professional in-vitro diagnostic products manufacturers, has announced that its Flowflex SARS-CoV-2 Antigen Rapid Test has been CE marked for self-testing. Read more
17 May 2021
West scales up Waterford plant in response to COVID-19 demand
West Pharmaceutical Services has scaled up its Waterford Ireland plant’s working schedules in response to a big surge in customer demand as a result of the COVID-19 pandemic. Read more
17 May 2021
Partnership sets up demonstration lab to showcase transfusion solution
Biolog-id and Nicholson Consulting have joined forces to set up a demonstration lab located at Malvern Hills Science Park, Worcestershire. Read more
17 May 2021
Hertfordshire NHS Trusts expand use of virtual wards for COVID-19 patients
Hertfordshire Community NHS Trust (HCT) has collaborated with East and North Hertfordshire NHS Trust, NHS East and North Hertfordshire Clinical Commissioning Group, Princess Alexandra Hospital, HUC and Doccla to provide a virtual ward system. Read more
14 May 2021
Connected health firm helps facilitate AI adoption in bone trauma X-Rays
Connected healthcare specialist Wellbeing Software is working with French medical AI specialist GLEAMER to facilitate seamless AI adoption in bone trauma X-Rays. Read more
14 May 2021
Q&A: The technology behind domestic COVID certification
Med-Tech Innovation News spoke to Andy Reid, founder of tested.me, about its technology that provides COVID certification as the UK continues to emerge from lockdown. Read more
17 May 2021
How tech is supporting children’s mental health
Helen Spiers, head of counselling at Mable Therapy, explains how and why technology supports the mental health of children. Read more
14 May 2021
Digital transformation: A tipping point for medical device manufacturers
After a report from SYSPRO detailed business resiliency during the COVID-19 pandemic, and highlighted the need for digital transformation, Roger Landman spoke to Med-Tech Innovation News to highlight how it could help medical device manufacturers. Read more
12 May 2021
Eight key considerations when introducing new medtech
Over the last decade, the healthcare industry has seen various technological advancements. This has led the healthcare industry to become more complex, and achieving growth is becoming more challenging. Read more
11 May 2021
How a proactive approach can help healthcare organisations mitigate cyber-attacks
Keith Glancey, systems engineering manager at Infoblox, explains how being proactive and ramping up approaches to cybersecurity, is the best approach. Read more
17 May 2021
Tunstall Healthcare
Technology-enabled care during the pandemic and how it can support collaboration
Zillah Moore, director at Tunstall Healthcare, discusses the need for a digital revolution and why investing in technology will ensure the delivery of essential care services to meet the needs of a post-pandemic population. Read more
14 May 2021
Q&A: How an ovarian cancer liquid biopsy test can make a lasting difference to women's health
Oriana Papin-Zoghbi, CEO and co-founder of AOA spoke to Med-Tech Innovation News to discuss its offering, which includes an early-stage ovarian cancer biopsy test. Read more
4 May 2021
Medtech and the backlog: a surge of new acute patients?
Oli Hudson, content director at Wilmington Healthcare, explores where the NHS is with the elective care backlog – and what it could mean for industry. Read more
30 Apr 2021
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Take to the stage: A preview of Med-Tech Innovation Expo's conference line-up
Med-Tech Innovation’s conference team guide us through what to expect across three stages for September’s show. Read more
Debating the EU & AstraZeneca's COVID-19 vaccine lawsuit
Ian Bolland and Reece Armstrong are joined by Joe Barnes, Brussels correspondent from the Daily Express as the trio discuss the latest developments in the ongoing dispute between AstraZeneca and the European Commission over COVID-19 vaccines. Read more
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Efficient cleanrooms benefit from turnkey design & build innovation
The requirement for cleanrooms has expanded rapidly over recent years with the increase in high precision engineering as well as pharmaceutical, medical and nano production. Read more
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