Precision medicine company My Next Health Inc. (MNH) has guaranteed a $150 million equity capital commitment from Global Emerging Market (GEM), a $3.4 billion Luxembourg-based private investment group. MNH was formed in May 2020 due to a merger between functional genomics company The DNA Company and digital therapeutics platform My Pain Sensei. The New York-based company is developing genomics-based health management applications that offer patients personalized genetic insights.

Reports of increased alcohol use began early in the pandemic and, with many counseling services and physicians’ offices closed or more difficult to access, therapists worried that an increasing number of patients with substance use disorders would be unable to find effective treatment. In that gloomy setting, San Francisco-based Woebot Labs Inc. reported cheering news in the October issue of Drug and Alcohol Dependence.

Nec Corp. is branching out into new health care and life science businesses, which will make use of artificial intelligence (AI) and other digital technologies. It is targeting a business value of ¥500 billion (US$4.56 billion) for these new areas by 2030. “Nec already announced this in our Mid-term Management Plan 2025 and is creating this health care and life sciences business to help drive future growth. As to why we chose 2030, it relates back to our Nec 2030VISION outlined in the plan,” an Nec spokesperson told BioWorld.

The U.K. government has doubled down on its overarching strategy for artificial intelligence (AI) with a 10-year plan to sustain the nation’s place in the global AI race. One of the key considerations in this plan is to revisit the criteria for status as an inventor, a clear nod to the dilemma presented by proponents of allowing the DABUS algorithm to be named as an inventor.

The FDA granted de novo marketing authorization for Paige Prostate, artificial intelligence (AI)-driven software that improves detection of prostate cancer. The clinical study submitted to the FDA demonstrated that using Paige Prostate resulted in a 7% improvement in sensitivity in correctly diagnosing cancer, increasing from 89.5% to 96.8%.

While European health care systems have historically lagged the U.S. in terms of digital adoption, a report by investment firm Albion VC is highlighting how the pandemic has created the momentum for change.

The med-tech regulatory picture is already in a state of flux thanks to changes imposed by the EU, but device makers and those in the digital health space might soon be facing yet another series of profound changes in Europe. The U.K. Medicines and Health Care Products Regulatory Agency (MHRA) has proposed to revamp its regulatory framework for both traditional medical device and for software/artificial intelligence, adding yet more uncertainty to an already turbulent European regulatory environment.

The COVID-19 pandemic is still swirling about, and rapid antigen tests are still playing a vital role in pushing back against the COVID-19 pandemic, and Australia’s TGA has responded with a guidance on when software used with rapid antigen tests qualifies as a regulated device. The TGA has classified such software as a class 3 device when used with a rapid antigen self-test, thus requiring a separate regulatory application before it can be eligible for entry in the Australian Register of Therapeutic Goods (ARTG).