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.

Invitae Corp. continued its aggressive cost-cutting initiative with the sale of its reproductive health assets to Natera Inc. for $10 million in upfront cash and an additional $42.5 million in potential milestone payments and litigation credits. The assets include screening tests for carrier status and non-invasive prenatal screening.

Genotype assay testing can detect new variants of the COVID-19 virus six days faster than whole genome sequencing (WGS), with results returned in just three days — compared to nine for WGS — according to a study published in the Lancet Microbe.

Clarius Mobile Health Inc. received CE mark for its latest wireless hand-held whole-body ultrasound scanner, the Clarius PAL HD3. The scanner combines both phased and linear arrays on a single head which provides high image quality of superficial and deep anatomy allowing for better diagnostic capabilities and patient care.

The question of the U.S. FDA’s statutory authority to regulate lab-developed tests (LDTs) is still percolating, and the FDA and the Centers for Medicare & Medicaid Services (CMS) have issued a joint statement that takes aim at that very question.

Researchers at ETH Zurich have identified a proteomic signature that could recognize long COVID six months after acute infection. Biologically, the signature indicated that the complement system remained active in patients with long COVID six months after infection. Translationally, it could lead to a diagnostic test for long COVID, and suggests that targeting the complement system could be a therapeutic approach to prevent or treat the disorder.

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.

In a potential godsend for women struggling with infertility and painful periods, Hera Biotech Inc. acquired the endometriosis diagnostic assets of Scailyte AG, consolidating the two leading tissue-based diagnostic programs for the disease. The combination of the companies’ non-surgical diagnostic options could significantly speed time to treatment for millions of women, who on average spend 10 years in search of the cause of chronic pelvic pain before being diagnosed with endometriosis.

A team of inventors predominantly based in the state of New York are seeking patent protection for an earbud system that integrates real-time electroencephalography (EEG) monitoring with audio playback. Using specialized silicone electrodes, it captures and interprets EEG data, serving as a passive and continuous tool for screening neurological conditions.