The MHRA will build its new UK system of medtech regulation on seven regulatory pillars, one of which is an IVD roadmap, says diagnostics industry association BIVDA. The trade body gave an update on the focus groups, UKAB numbers and timings for three awaited statutory instruments.
“We’re waiting for the first statutory instrument (SI),” said Ashleigh Batchen. “That’s a crucial next step as the UK continues to build its standalone medtech regulatory system, and would solidify that we have the [new] date of application,” BIVDA’s head of regulatory affairs told Medtech Insight.
The new date of application of the UK system will be 1 July 2024, a year later than initially planned by the Medicines and Healthcare products Regulatory Agency (MHRA). The...
The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.
Post-market surveillance regulations for medtech system users in Great Britain coming into force on 16 June will make new data requirements under new compliance deadlines.
King’s College London, Imperial College London and The Alan Turing Institute constructed cardiac digital twins at scale, creating over 3,400, in a new study using UK Biobank data published in Nature Cardiovascular Research on 16 May.
Flo Health was the first femtech unicorn to be valued at over $1bn. But the company faced 49 investment rejections before reaching that status, Anna Klepchukova, the company’s chief medical officer, told the LSX World Congress Europe. THENA Capital’s Esther Reynal de St Michel Richardot talked through the firm’s gender-smart investment strategy.
The consumer genomics firm will operate as a subsidiary, while Regeneron plans to leverage its database for drug discovery and trial design efforts.
FemTech leaders discussed some of the barriers that remain in unlocking the full potential of the women’s health market during SiS New York last week. They also offered solutions.
King’s College London, Imperial College London and The Alan Turing Institute constructed cardiac digital twins at scale, creating over 3,400, in a new study using UK Biobank data published in Nature Cardiovascular Research on 16 May.
