Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Applied Biocode, Fist Assist, Mdoloris, Mindray.
PARIS – Dyameo SAS has successfully raised $1.13 million in seed funding to develop its endoscopy probe used for the instantaneous detection of cancerous cells. This round was led by Medevice SAS and Aquiti Gestion SAS via its co-investment fund, NACO.
Depixus Ltd. has raised $35.4 million in an oversubscribed series A financing to push commercialization of its Magna multiomics system. The series A round was co-led by Lansdowne Partners and PSIM Fund, with participation from Casdin Capital and existing investor Arix Bioscience. The funds bring the company's total equity and grant funding to more than $47 million.
At more than $48.2 billion raised through mid-December, the med-tech industry has recorded another stellar financing year – one that is 19% below 2020, but above every other year to date.
With the U.S. Securities and Exchange Commission (SEC) and Cyberspace Administration of China (CAC) imposing stricter regulatory requirements on listing companies, more Chinese companies are likely to decide to list on stock exchanges closer to home.
Clinical trial fraud has not been on the radar screen for drug and device makers in recent years, but there have been several episodes in which the operators of clinical trial sites had fabricated data for clinical trials. U.S. deputy assistant attorney general Arun Rao said recently that clinical trial fraud is now front and center for federal attorneys, raising the risk that any documentation errors for clinical trials will create a massive liability for the sponsor.