Medtech Regulatory News
Vascular disease treatment designated FDA Breakthrough Device
Endologix LLC, a developer of vascular disease treatments, has been granted Breakthrough Device Designation from the Food and Drug Administration (FDA) for its ChEVAS (Chimney EndoVascular Aneurysm Sealing) System. Read more
20 Jul 2021
BPR Medical receives MDSAP certification for medical gas solutions
BPR Medical, a UK-based independent manufacturer of medical gas products, has received Medical Device Single Audit Program (MDSAP) certification for its medical gas solutions. Read more
14 Jul 2021
Webinar to discuss life sciences labelling solutions
Epson, NiceLabel and 3M are coming together to host a webinar on Thursday, 15th July at 7 p.m. BST to discuss life sciences label materials, software and printing solutions and present best practices for managing all of their labelling requirements. Read more
12 Jul 2021
Natural Cycles receives FDA clearance for birth control wearable
Natural Cycles, the first FDA cleared birth control app, has received new FDA clearance to revise its labelling and expand the types of third-party thermometers, which include consumer wearables already on the market, that can be used with its app. Read more
9 Jul 2021
Biocomposites receives Canadian approval for Stimulan
Biocomposites has announced that its Stimulan products have gained a new Canadian approval for mixing with antibiotics: vancomycin, gentamicin and tobramycin, for use in treating bacterial infection in soft tissue surrounding bone. Read more
8 Jul 2021
Free IVDR filtering tool offered by regulatory and quality consulting firm
A new, freely available In Vitro Diagnostic Regulation (IVDR) filtering tool is being offered by RQM+, a medical device and diagnostics focussed regulatory and quality consulting firm. Read more
5 Jul 2021
The EU's AI Regulation - what does it mean for UK medtech?
Brett Lambe, senior associate in the technology team at Ashfords LLP, examines what a new AI Regulation from the EU could mean for medtech. Read more
16 Jul 2021
Five steps to prepare for UKCA compliance
Ed Ball, senior associate, RQM+ summarises the requirements of the UK Conformity Assessment certification (UKCA mark) and highlights top priority areas for attention. Read more
22 Jun 2021
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Getting art smart: How to eradicate errors in packaging artwork
While production labelling controls often attract greater attention, errors in packaging artwork and IFU design files can still prove problematic. Read more
17 Jun 2021
A detailed application wins the day: U.S. medical device patenting considerations
Neil Thompson, patent agent, and Elie Gendloff, Ph.D., J.D., patent attorney at Torrey Pines Law Group, PC examines the key aspects to patent applications for medical devices in the United States. Read more
4 Jun 2021
EU MDR has arrived - what challenges remain?
Today’s date of application of the Medical Device Regulation (MDR) marks an important milestone for the medical devices sector. Read more
26 May 2021
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Getting art smart: How to eradicate errors in packaging artwork
While production labelling controls often attract greater attention, errors in packaging artwork and IFU design files can still prove problematic. Read more
Abingdon Health signs exclusive manufacturing deal with BioSure
Abingdon Health, a developer and manufacturer of rapid tests, it has signed an exclusive manufacturing agreement with BioSure, a UK company specialising in the provision of rapid in-vitro diagnostic testing solutions. Read more
23 Jul 2021
Deadline for booking ABHI UK Pavilion place at MEDICA approaching
UK companies wanting to showcase their products and services at this year’s MEDICA trade fair have until 29th July 2021 to book their pace on the ABHI UK Pavilion. Read more
23 Jul 2021
Spex Capital and MedCity join forces to fund promising ventures
Spex Capital, a digital health and medtech investment firm, has joined forces with MedCity to identify and fund promising healthtech ventures, accelerating their route to commercialisation and uptake in healthcare systems globally. Read more
22 Jul 2021
B-Secur and Texas Instruments partner on ECG/EKG monitoring
B-Secur has launched an electrocardiogram (ECG) solution based on the Texas Instruments (TI) AFE4950 analogue front end (AFE) for photoplethysmography (PPG) and ECG sensing that will accelerate the design of next-generation consumer wearables. Read more
22 Jul 2021
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New screening service to identify children at risk of heart disease
Thousands of toddlers will be screened for an inherited gene that can cause early heart disease as part of a new national pilot programme. Read more
22 Jul 2021
Sticking point: Innovations post-COVID
Ian Bolland is joined by Dr Anne Blackwood from HEE, as they they delve into more about a potential culture change when it comes to making innovations stick post-COVID, and what industry and regulation can do to aid momentum. Read more
26 Jul 2021
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How a digital tool can improve the care of osteoporosis patients
Ian Bolland sat down with the team from UCB to discuss BoneBot, the technology it is developing to help osteoporosis patients. Read more
20 Jul 2021
Improving home care with machine learning and behavioural analytics
Nick Weston, CCO, Lilli explains how home care can be transformed for good when machine learning and behavioural analytics are applied. Read more
19 Jul 2021
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Effective manufacturing test strategies for improved connected devices
Sook-Hua Wong, industry segment manager, Keysight Technologies, addresses how the Internet of Medical Things has highlighted the importance of investing in quality manufacturing testing strategies. Read more
15 Jul 2021
How an automated system can track hydration levels
Aquarate has developed Hydracare – an automated fluid monitoring system that tracks how much an individual drinks using their Hydracup. Read more
23 Jul 2021
Reducing noise to improve accuracy of medical devices
Nick Pearne, director of business development, TransSiP, explains one aspect that can make wearable devices more accurate. Read more
22 Jul 2021
How technology can play a key role in fixing social care
Elspeth Briscoe, founder & CEO of Learning with Experts, explains the role in technology can play when it comes to informing any plans for social care. Read more
21 Jul 2021
What better time to build a UK diagnostics sector fit for the future?
Geoff Twist, managing director, Roche Diagnostics UK & Ireland, outlines why it’s time to seize the moment for the diagnostics industry. Read more
21 Jul 2021
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Webinar
WEBINAR: Design for Complex Sterile Packaging Applications
In this upcoming webinar, Kevin Fisher and Tommy Smith, PhD, from Oliver Healthcare Packaging, share details, lessons learned, and best practices to help you succeed with your next packaging design! Read more
Sponsored
FOXARTBOX / Shutterstock.com
Getting art smart: How to eradicate errors in packaging artwork
While production labelling controls often attract greater attention, errors in packaging artwork and IFU design files can still prove problematic. Read more
Sticking point: Innovations post-COVID
Ian Bolland is joined by Dr Anne Blackwood from HEE, as they they delve into more about a potential culture change when it comes to making innovations stick post-COVID, and what industry and regulation can do to aid momentum. Read more
Sponsored
Med-Tech Innovation Expo opens visitor registration for 2021
Med-Tech Innovation Expo has opened visitor registration for the 2021 edition of the event, complete with a programme of 40+ speakers, 200+ exhibitors, and the launch of a new event platform for attendees to manage their experience. Read more
ARRANGE A WEBINAR
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