The U.S. FDA has announced the next stage in its program to down-classify a series of in vitro diagnostics (IVDs) from class III to class II, a change that would significantly ease the premarket requirements for these test types. Much of the emphasis here is on companion diagnostic (CDx) tests, a category of products that is the focus of a separate FDA imperative, but there are those who view this down-classification regime as little more than a meager attempt to paste over a massive impending regulatory overhang.

In what represents its first patenting, Copenhagen, Denmark-based HEI Therapeutics ApS reported seeking patent protection for a point-of-care or home monitoring solution, which enables personalized treatment for hypothyroidism.

A blood test developed by Datar Cancer Genetics Inc. for the detection of glial malignancies (GLI-M) could be a breakthrough for the diagnosis and treatment of brain cancer, according to a study published recently in the International Journal of Cancer.

Inventors affiliated with Nirsense LLC, are designing somatic and cerebral oximetry devices using functional near-infrared spectroscopy (fNIRS). They have filed for patent protection of wearable systems capable of detecting both optical and non-optical biometric properties of a user to determine their cognitive state.

In its first patenting, Cambridge, U.K.-based Opto Biosystems Ltd. is seeking protection for implantable sensors that may be used in systems to measure chemical, biological, or electrical signals in the central and/or peripheral nervous systems.

The $4.5 million in seed funding that Acorai AB recently raised will allow the company to continue its forward momentum in developing its technology to support the treatment of patients living with heart failure, Matthew Mace, co-founder and chief scientific officer told BioWorld. In practice, this means that with the funds the company will be able to meet its “projected timelines on the path toward regulatory approval in the U.S., focus on market entry and get the device into the hands of health care professionals sooner.”

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).

In a post-pandemic world, South Korean molecular diagnostics firm Seegene Inc. is looking to ignite a new paradigm in the diagnostics business. Seoul-based Seegene is rolling out a new strategy of open innovation under its newfound initiative coined the “SG Onesystem,” which pledges to not only accelerate global partnerships for novel diagnostics but also “free the world of all disease.”

The European Commission (EC) has proposed another delay in the compliance deadlines for the In Vitro Diagnostic Regulation (IVDR) that eases the existing timelines by roughly two and a half years. The news was welcomed by Medtech Europe, which nonetheless pressed the EC and others to patch up some of the issues that led to the new extensions in the first place.

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.