Harmonization through increased centralization was a key theme that ran through a recent discussion between Erik Vollebregt and Tom Melvin about the MDR. Both agreed that far-reaching short-term changes are not only possible but vital.
We are currently in a period where it is as if the EU medtech regulations are being stirred round in a cauldron by three witches representing the EU institutions who must agree any new regulatory proposal.
And no one knows quite what will come out of
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.
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.
A battle may be forming over the 2027 FDA user fee reauthorizations. At a conference Friday, Democratic Rep. Jake Auchincloss supports them for their effectiveness, while Deputy FDA Commissioner Grace Graham echoed criticisms from HHS Sec. Kennedy, among others, in calling for reform to ensure public trust.
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.
