Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Bausch + Lomb, BD, Caption Health, Micro-Tech, Zimmer Biomet.
The U.S. FDA’s guidance for unique device identifiers (UDIs) is heavily adjusted to account for a device’s inherent risk class, and many class I devices are now going to enjoy another reprieve from UDI requirements per an updated FDA guidance.
Institut Mérieux SA is offering equity to a preferred partner via a restricted capital increase. Exor NV has consequently acquired 10% of Institut Mérieux’s capital by investing $850 million. A third of this new funding, some $285 million, will be injected immediately this summer, with the balance following over the coming 12 months.
A committee of the U.S. House of Representatives is moving forward with a bill that would extend Medicare telehealth provisions for two years after the end of the COVID-19 public health emergency, but the legislation lacks features to deal with fraud and abuse.
The U.K. NHS is implementing the use of Oxford, U.K.-based Genincode plc’s predictive genetic test for patients suffering with hypercholesterolemia and familial hypercholesterolemia (FH). The Academic Health Science Network for the North East and North Cumbria (AHSN NENC) is adopting the Lipid Incode test in Darlington following a successful pilot study which demonstrated the test can detect and diagnose people with high cholesterol, a known risk factor for the development of cardiovascular disease (CVD). It is the first commercial polygenic test for CVD to be implemented by the NHS.
Exo Inc. acquired Medo Dx Pte, an artificial intelligence (AI) developer, to make its point-of-care ultrasound imaging even easier to use. Medo brings two FDA-cleared artificial intelligence algorithms that draw on a library of millions of ultrasound images and health data to expand the settings for ultrasound and the reduce the expertise required for its use. Terms of the deal were not disclosed.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Bio Molecular, Co-Diagnostics, Dexcom, Elitechgroup, Hyperfine, Infandx, Embic, Lumithera, Maculogix, Oracle Cerner, Perceptive Solutions, Perkinelmer, Viz.ai.