The U.S. FDA’s recent warning letter to Danvers, Mass.-based Abiomed Inc., may have come across as an enforcement outlier in the context of the agency’s controversial final guidance for clinical decision support (CDS) products.

The unique device identifier (UDI) might not be the most exciting U.S. FDA enforcement mandate for most of regulated industry, but the FDA’s Keisha Thomas indicated that compliance is less than adequate in the agency’s view.

The COVID-19 pandemic took a huge bite out of the U.S. FDA’s ability to conduct inspections in a timely manner, but the FDA’s Douglas Stearn said the agency has nonetheless ramped up these activities.

Artificial Intelligence (AI) driven tools have the ability to design new drugs, with a bit of help from humans, said Anders Hogner, from Astrazeneca plc’s R&D department at the Bio-IT World Conference & Expo Europe in London. “We don’t have anything out there yet,” he added, but the company appears to be working on it.

One of the difficulties for preventing the evolution of a tumor is that cancer progression can be promoted by undifferentiated or migrating cells whose states could follow different directions. At the 40th edition of Barcelona Biomed conferences at the Institute for Research in Biomedicine (IRB Barcelona), which took place from Nov. 27 to 29, 2023, and is entitled “Cancer in Context: Cellular, Tissue, and Organismal Determinants of Malignant Fates,” Angela Nieto presented her latest data on epithelial-to-mesenchymal transition (EMT).

One-year data from Xeltis AG’s first-in-human Axess vascular conduit trial showed outstanding results in patients with end stage renal disease who were deemed unsuitable for arteriovenous (AV) fistula creation. The results, presented at the VEITHsymposium in New York, showed 100% secondary patency, 78% primary assisted patency and no infections were observed in data from 20 patients implanted with the Axess conduit.

Siemens Healthineers AG appears to be committed to its Diagnostics business after Jochen Schmitz, CFO, pushed back at rumors speculating that the German company was looking at options for the underperforming segment, including a sale.

Senior leaders and investors in the health care sector expect mergers and acquisitions (M&A) activity to continue to pick up next year but this will be corporate led rather than private equity, according to a report by global investment bank Jefferies. At the same time, many executives remained concerned about the lack of funding in the sector as it was identified as the number one threat.