French remote monitoring and software startup Implicity SAS won FDA clearance for its ILR ECG Analyzer, a medical algorithm that analyzes electrocardiogram data from implantable loop recorders (ILRs). The company plans to launch the artificial intelligence (AI)-powered algorithm, which also is CE marked, in both the U.S. and Europe beginning next month.

DUBLIN – ITM Isotope Technologies Munich (ITM) SE has secured its first radiopharmaceutical licensing deal in China, a pact with Grand Pharmaceutical Group Ltd. involving two radiopharmaceutical candidates, as well as a companion diagnostic for one of them.

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.

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.

Becton, Dickinson and Co. (BD) completed its acquisition of Scanwell Health Inc., its partner in development of the smartphone-enabled BD Veritor At-Home COVID-19 Test, just in time for increased demand driven by the Omicron surge in the U.S. and plans to make the tests available for free by the federal government as well as several states and large municipalities. Currently, most of the tests distributed by governments are made by Abbott Laboratories, which received emergency use authorization (EUA) for its at-home test in March 2021.

As the Omicron variant of COVID-19 sweeps across the globe, the Biden administration has announced a program to purchase 500 million rapid antigen tests to help slow the pandemic. The news comes at an especially critical time, given the increased transmissibility of the Omicron variant, but the promised volume is unlikely to be achieved by the first day of January 2022.

2021 may mark the beginning of a new phase in treatment of depression. While genetic matching of depression therapies to patients has been touted for a decade, meta-analyses have not supported claims of improved response rates with studies often finding that any improvements seen likely came from switching patients to guideline-recommended therapies rather than any insight from genetics.

Bond Digital Health Ltd. landed £1 million (US$1.3 million) from investors to expand development of its Transform data management system for lateral flow diagnostic tests. The technology connects to an app that captures data from lateral flow assays in self-testing settings. The results are then shared to a dashboard that can be monitored by the platform admin. The new investment included equity funding from the Development Bank of Wales and high-net-worth investment service Wealth Club. In addition to the current round, Bond is aiming to raise a further £500,000 by January.