Announcements of new radiology solutions enhanced by artificial intelligence (AI) and machine learning appeared almost daily in 2021, all promising more accurate diagnoses in less time and increased productivity and confidence for radiologists. Hospitals and health care systems have increasingly recognized the advantages of these systems, with Sage Growth Partners reporting that 90% of hospitals have an AI strategy in place, up from 53% in 2019, but the deployment lags, with only 34% of hospitals having installed an AI solution. Read More
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. Read More
PERTH, Australia – Inventia Life Science Pty. Ltd. closed a A$35m (US$25 million) series B round that will see the company bring its Rastrum 3D cell culture platform to the U.S. market. The technology can “revolutionize the way drug discovery is done,” Inventia Founder and CEO Julio Ribeiro told BioWorld. Read More
LONDON – Brainomix Ltd. has raised £16 million (US$ 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. Read More
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. Read More
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. Read More
Device makers have been making use of computational modeling and simulation (CMS) for device design for a number of years, and the FDA has released a draft guidance for how agency reviewers will assess the credibility of those models. However, the agency said there is a paucity of analytical methods for evaluating these tools, a factor that may add drag to the agency’s review of industry’s use of products and data thus developed. Read More
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. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Avacta, Phillips, Sight Sciences. Read More