The U.S. FDA accepted Novocure GmbH’s premarket approval (PMA) application to use its Tumor Treating Fields (TTFields) technology together with standard systemic therapies to treat non-small cell lung cancer (NSCLC) following progression on or after platinum-based therapy. Novocure hopes that the application, under review, will get the green light and the therapy, which uses electric fields to disrupt solid tumors and kill cancer cells, will be on the market in the second half of 2024.

Pearsanta Inc., a subsidiary of Aditxt Inc. formed in Feb. 2023, acquired MDNA Life Sciences Inc. for $25 million in stock, marking Aditxt’s second deal announced in a month. The company moved into the women’s health market with the $100 million planned acquisition of Evofem Biosciences Inc., maker of the contraceptive gel Phexxi, which it reported on Dec. 12. The deals show boldness on the part of Aditxt’s management team as the company just announced it regained compliance with Nasdaq’s continued listing rule for minimum stockholder’s equity on Jan. 2.

A new study published by researchers from the Tokyo University of Science (TUS) unveiled a new machine learning-aided, non-invasive imaging framework for rapid liver lipid visualization, which could help diagnose and treat steatotic liver diseases (SLD).

B-rayz AG received CE mark for its Data Adaptive Neural Artificial Intelligence (DANAI) technology that helps clinicians with breast cancer detection. The company hopes that DANAI, which introduces a custom AI-based framework that can adapt to clinicians needs and grow smarter in the process, will revolutionize the diagnostic landscape for breast imaging and transform the lives of millions of women.

Dxcover Ltd. initiated three pivotal trials to measure the efficacy of its liquid biopsy platform for early detection of brain, colorectal and lung cancers. The company hopes the trials will provide the evidence needed to gain regulatory approval and begin commercial operations of its diagnostic technology in Europe and the U.S.

Boehringer Ingelheim GmbH partnered with Newcastle University and the University of Edinburgh to fund a £30 million (US$38 million) study into liver cirrhosis in a bid to provide scientists with new insights into liver health. The partners hope that the study will not only enhance the understanding of nonalcoholic or metabolic dysfunction-associated steatohepatitis (NASH/MASH) cirrhosis, but also help identify translational biomarkers using a cutting-edge approach called single-cell RNA sequencing to accelerate the development of future therapies.

Veracyte Inc. revealed plans to buy C2i Genomics Inc. at the J.P. Morgan Health Care Conference in San Francisco on Jan. 8, a move that will significantly expand its portfolio of cancer diagnostic and monitoring assays. The terms include $70 million in Veracyte shares to be paid at closing plus an addition $25 million payable in cash or Veracyte shares over the next two years if C2i achieves certain performance milestones.

Echoing trends seen last year, the med-tech industry concluded 2023 with a continued surge in deal value juxtaposed against a more substantial decline in M&A value. Deal value for the year, including licensings, collaborations and joint ventures, reached $10.63 billion from 1,656 deals, the highest annual value in BioWorld’s records.

Natera Inc., said it has won a preliminary injunction against Neogenomics Inc., which halts any distribution of the latter’s RaDaR (Residual Disease and Recurrence) assay for detection of residual cancer DNA. The matter is anything but closed, and Neogenomics stated that it will appeal the decision, suggesting that this dispute will roll into and play out through much of 2024.

MLA Diagnostics BV secured a strategic seven-figure investment in its recent investment round to support external validation of the company’s melanoma prognosis test. Co-founders NLC Health Ventures and Brightlands Life Sciences Ventures participated in the round along with LIOF, the regional development organization for the Limburg province of the Netherlands.