Oxford Biodynamics plc is launching its clinical assay Episwitch CIRT in the U.S. following clinical validation that demonstrated the 3D genomic eight biomarker panel can predict a cancer patient’s response to immune checkpoint inhibitor (ICI) therapy at up to 93% sensitivity, 82% specificity and 85% accuracy. ICIs are currently used against more than 15 types of cancer but less than one in three patients show any benefit from the treatment.

The U.S. Federal Trade Commission has signed off on an amendment to the divestiture plan for Boston Scientific Corp. (BSX), of Marlborough, Mass., related to the acquisition of British Technology Group plc (BTG).

The European Union’s (EU) Medical Device Coordination Group (MDCG) posted a guidance addressing verification of manufactured, high-risk in vitro diagnostics (IVDs), which indicates that manufacturers should submit samples to a reference lab for batch testing. However, the requirement for batch testing may not apply if no European reference lab has been designated for a test type, suggesting that some high-risk tests may go to market without adequate testing.

PARIS – Siemens Healthineers AG has unveiled its growth plans for 2025 at its annual general meeting. The Erlangen, Germany-based medical technology giant, valued at nearly $67 billion on the Frankfurt stock exchange, is ramping growth. “We are setting ourselves the objective of annual growth of up to 8% on a like-for-like basis up to 2025, compared with a previous objective of 5%,” said Ralf Thomas, supervisory board chairman, Siemens Healthineers AG. Adjusted earnings per share should, accordingly, rise by 15% a year over that period as part of this strategic plan, compared with a target of at least 10% previously.

Japan’s Ministry of Health, Labor and Welfare (MHLW) released a number of new guidelines and clarifications on medical device regulatory issues including cybersecurity, remanufactured single-use devices (SUDs) and the Medical Device Single Audit Program (MDSAP).