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Ben Kemp

FDA updates Regulatory Affairs NewsletterFDA Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

FDA Classification update

FDA have updated their classification codes for devices intended: To detect and identify nucleic acid targets including SARS-CoV-2 in respiratory specimens (Class II with special controls), To detect and identify selected microbial agents that cause acute febrile illness (Class II with special controls)
Ben Kemp
August 20, 2024
HighlightsHighlights Archive

Media Monitoring: 15 – 21 August

Unleashing health and prosperity throughout Britain - NHS Confederation & PPR A report released by NHS Confederation and Institute for Public Policy Research has shown that inequalities in healthy life expectancy are widening across the country. In some local authorities, people are expected to live 20 more years in good health compared to other local authorities.   China’s new blood test…
Ben Kemp
August 20, 2024
Membership NewsMembership News Archive

BIVDA respond to integrated, rules-based medtech pathway consultation

BIVDA have submitted our response to NHSE and NICE’s recent consultation on their proposals for an integrated, rules-based medtech pathway. We broadly welcome the pathway’s potential to assist with the adoption of innovation in the NHS. However, we have come concerns regarding delivery. There is also wariness among industry that NHSE will place unrealistic demands on developers.  Successful, realistic delivery…
Ben Kemp
August 20, 2024
Membership NewsMembership News Archive

ReMed Conference 2024 – Beyond Disposal: Building a Circular Economy for Medical Devices

The ReMed Conference 2024 - Beyond Disposal: Building a Circular Economy for Medical Devices will take place all-day on 17 September at Loughborough University. Leading industry and healthcare practitioners will be talking about challenges and drivers in the medical device sector and will also discuss work being done by leading researchers in the field of circular economy for medical devices.…
Ben Kemp
August 20, 2024
Membership NewsMembership News Archive

Updated Infection Management Coalition website now live

A brief note to members that the Infection Management Coalition's website has recently been updated and is now live. You can access it here. The Infection Management Coalition (IMC) is a group of charities, professional societies, industry bodies and life science companies that have come together to advocate for a holistic approach to infection management to better protect citizens, the…
Ben Kemp
August 20, 2024
Membership NewsMembership News Archive

New EFLM scientific paper published

The EFLM Working Group "Preanalytical Phase" and the EFLM Task and Finish Group "Urinalysis" have published the following scientific paper, which may be of interest to members: Preservation of urine specimens for metabolic evaluation of recurrent urinary stone formers. The paper concluded that detailed procedures are needed to collect urine specimens for analysis of urinary stone-related metabolites, considering both patient…
Ben Kemp
August 20, 2024
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