LONDON – Brainomix Ltd. has raised £16 million (US$ 21.2 million) in a series B, enabling the company to extend its artificial intelligence (AI)-driven diagnostic platform beyond the initial deployment in stroke, to the assessment of disease progression in lung fibrosis, and response to therapy in lung cancer.
The FDA has posted two draft guidances for the transition of policies from the pandemic to more normal times. One of these is the long-awaited draft for transitioning a device from an emergency use authorization (EUA) to a conventional premarket status, which offers a 180-day grace period for an EUA after the agency identifies a date on which the EUA will be terminated.
Investor appetite for digital mental health technologies is expected to continue in 2022, although startups will face the challenge of standing out from competition. Venture capital firm Rock Health reported funding for digital mental health startups was the top-funded therapeutic focus in 2021, with $3.1 billion raised by the end of Q3. Key trends are emerging, as investors seek companies addressing complex mental health conditions.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Avacta, Phillips, Sight Sciences.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: BD, Carestream Dental, Cue Health, Envista, Everly Health, Ixensor, Lucira, Nevro, Nalu.
The EU is on its way to becoming one of the first to implement a historic global tax reform agreement, setting a minimum effective tax rate of 15% for large multinational groups, including biopharma and med-tech companies.