Medtech Regulatory News
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
Robotic gamma probe for intra-operative cancer detection gains CE mark
Lightpoint Medical, a medical device company developing miniaturised surgical tools for advanced intra-operative cancer detection, has received CE mark approval for SENSEI, a robotic gamma probe. Read more
21 Jan 2021
Bone cutting laser system receives CE mark
The patented CARLO system developed by the Swiss medtech start-up AOT cuts bones precisely and contact-free with a specialised laser using a robot. CARLO stands for Cold Ablation Robot-guided Laser Osteotome. Read more
18 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
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
Computing firm introduces new range of surgical monitors
Computing firm ADLINK Technology has introduced the ASM (ADLINK Surgical Monitor) series of surgical monitors, which are designed for integration with endoscopic, microscopic, fluoroscopic, multi-modality, and other medical imaging systems. Read more
27 Jan 2021
PVC compounds firm to continue growth and innovation strategy
PVC compounds and ecological biopolymers firm Benvic, is set to continue its strategy of growth and innovation within the world’s medical and healthcare sectors. Read more
27 Jan 2021
Dem Dx and Moorfields Eye Hospital awarded £1.1m to develop triage platform
Healthcare company Dem Dx and Moorfields Eye Hospital NHS Foundation Trust have been awarded £1.1 million to develop and evaluate Dem Dx’s AI-powered clinical reasoning tool ‘Triage Platform’ for eye health services. Read more
27 Jan 2021
Draeger opens PPE manufacturing facility in Gateshead
Draeger Safety UK, part of The Dräger Group, has officially opened a new manufacturing facility in Gateshead. Read more
27 Jan 2021
NHS tele radiology services provider to deploy Sectra's imaging technology
Teleradiology services provider Medica, which provides more than a million radiology reports each year to help NHS hospitals deliver diagnoses and effective care for patients, has announced it will deploy technology from medical imaging firm Sectra. Read more
26 Jan 2021
Draeger opens PPE manufacturing facility in Gateshead
Draeger Safety UK, part of The Dräger Group, has officially opened a new manufacturing facility in Gateshead. Read more
27 Jan 2021
AdvaMed supports President Biden's COVID-19 strategy in letter
The Advanced Medical Technology Association (AdvaMed) has confirmed its support to President Biden to work with the administration’s national COVID-19 strategy. Read more
25 Jan 2021
Assay launched to detect a patient's COVID-19 antibody levels
Clinical diagnostics firm Beckman Coulter has launched its Access SARS-CoV-2 IgG II assay in countries accepting the CE mark. Read more
25 Jan 2021
EKF Diagnostics moves to Cardiff facility to increase COVID-19 test production
EKF Diagnostics has expanded into new larger manufacturing facilities at Llandough Trading Estate, Cardiff, to increase production of PrimeStore MTM viral transport media, a key component for the COVID-19 testing regime. Read more
22 Jan 2021
Computing firm introduces new range of surgical monitors
Computing firm ADLINK Technology has introduced the ASM (ADLINK Surgical Monitor) series of surgical monitors, which are designed for integration with endoscopic, microscopic, fluoroscopic, multi-modality, and other medical imaging systems. Read more
27 Jan 2021
NHS tele radiology services provider to deploy Sectra's imaging technology
Teleradiology services provider Medica, which provides more than a million radiology reports each year to help NHS hospitals deliver diagnoses and effective care for patients, has announced it will deploy technology from medical imaging firm Sectra. Read more
26 Jan 2021
'My Pocket Therapist' app launched to address mental health challenges
A new app, My Pocket Therapist, has been launched in the UK to help combat mental health problems, including those caused by the effects of COVID-19. Read more
26 Jan 2021
Survey reveals 80% of healthtech firms have suffered a cyberattack
A new survey conducted by Irdeto and Censuswide, has revealed that 80% of healthcare technology providers have suffered a cyberattack. Read more
26 Jan 2021
Biotech firms strike partnership to strengthen R&D in metabolomics
Biotech players OWL and BIOSFER have entered into a strategic partnership with a view to strengthening R&D in developing diagnosis methods and personalised medicine using metabolomics. Read more
19 Jan 2021
Owlstone Medical introduces panel for respiratory disease research
Owlstone Medical, which uses Breath Biopsy for applications in early disease detection and precision medicine, has introduced the Respiratory Diseases Research Use Only (RUO) Panel. Read more
19 Jan 2021
Research lab for infection prevention and control opens
Test Labs, the new Peterborough-based research laboratory, is designed specifically for testing and researching questions around infection prevention and control with particular focus around healthcare environments. Read more
19 Jan 2021
Stream Bio wins SBRI funding for lateral flow heart diagnostic
Stream Bio, a UK-based company that develops and manufactures life science products, has announced a new project after winning funding through SBRI Healthcare’s ‘Urgent and Emergency Care’ competition. Read more
13 Jan 2021
LATEST AI & VR IN HEALTHCARE NEWS
AI-powered hearing aids recognised with award at CES 2021
Widex has been recognised by Digital Trends Media Group with a Tech for Change Award at CES 2021 for its Widex Moment hearing aids. Recipients were selected based on innovations intended to make the world a better place, as displayed during CES. Read more
25 Jan 2021
Kazz
NHNN becomes first NHS hospital to install Olympus ORBEYE
The National Hospital for Neurology and Neurosurgery (NHNN) has become the first NHS hospital to install ORBEYE. Read more
21 Jan 2021
Sensyne Health launches app to automate lateral flow results
Sensyne Health has announced the launch of MagnifEye, a new smartphone software application that uses deep machine learning AI to automate the accurate reading, beyond the human visible spectrum, and Big Data analsis of lateral flow diagnostic tests. Read more
14 Jan 2021
Edinburgh firm closes £1.2m funding round for neuromotor pen
Edinburgh medtech company Manus Neurodynamica has closed a £1.2 million funding round to support the launch of its digital pen which provides an early warning of Parkinson's disease and other neurological conditions. Read more
26 Jan 2021
mike mulcaaire
Sino-nasal treatment device firm closes $25m funding round
Neurent Medical, a company developing treatments for chronic inflammatory sino-nasal diseases, has closed a $25 million Series B financing. Read more
21 Jan 2021
EIT Health establishes Ireland base to expand and grow partnerships
EIT Health has established a base in Ireland to strengthen its existing network and grow new partnerships. Read more
14 Jan 2021
Beacon Hospital invests in 3D tech for neurosurgery
Beacon Hospital has invested €500,000 in Orbeye technology for neurosurgery, making it the first hospital in the UK and Ireland to use this equipment. Read more
11 Dec 2020
