A new cutting-edge blood-based biomarker test developed by researchers at Hong Kong University of Science and Technology can detect early Alzheimer’s disease (AD) and mild cognitive impairment (MCI), with accuracy rates surpassing 96% and 87% respectively, and could be a game changer in detecting and treading early AD.

Vessi Medical Ltd. recently closed a series A financing round at $16.5 million for the advancement of its cryotherapy technology to treat non-muscle invasive bladder cancer (NMIBC). Vessi believes that its minimally invasive device can provide a therapeutic alternative to a transurethral resection of bladder tumor (TURBT) procedure, the current first line therapy to treat the disease.

Zimmer Biomet Holdings Inc.’s Rosa robotics surgical assistant snapped up its fourth application with the U.S. FDA’s 510(k) clearance for use in shoulder replacement surgery. Over the past five years, the system has built a portfolio that includes partial and total knee replacement and total hip replacement.

Since its founding by the National Institutes of Health (NIH), the scientists of the All of Us Research Program have set the goal to analyze the largest diversity of the genomic population in the country and end the under-representation of its different groups. The project has expanded the vision of several pathologies, discovered thousands of new genetic variants, redefined the risk genes for common diseases, and stratified them, uncovering eight different forms in the case of type 2 diabetes (T2D). Their results create a pathway for a new age of precision medicine.

Instead of inter partes review (IPR) being a streamlined alternative to costly patent litigation as intended, a precedential decision by the U.S. Circuit Court of Appeals for the Federal Circuit could make appeals of IPR decisions, regardless of their merits, another way to delay competition.

The U.K.’s National Institute for Health and Care Excellence (NICE) has given people looking to lose weight another treatment option by recommending endoscopic sleeve gastroplasty (ESG) as a therapy to help treat obesity. The move comes amidst increasing awareness of the disease brought on by the growing prevalence of GLP-1 agonists.

Cagent Vascular Inc. secured more than $30 million in a series C fundraising round to increase availability of its Serranator PTA serration balloon catheters, which scores the endoluminal surface of arteries to enable greater expansion of obstructed vessels. A recent study demonstrated that Serranator also dramatically reduced elastic recoil, which could improve results of angioplasty in individuals with peripheral artery disease (PAD).

South Korea’s MFDS gave regulatory clearance to SK Inc. C&C’s artificial intelligence (AI) solution to diagnose cerebral infarction called Medical Insight+ Brain Infarct on Feb. 22, as a class III device.

The U.S. FDA’s December 2023 draft guidance for the use of real-world evidence (RWE) for medical devices drew comment from across the spectrum of stakeholders, but industry is demonstrably wary of the draft on several points. The Medical Device Manufacturers Association (MDMA) offered several pointed criticisms, including that the draft seems to suggest that a fit-for-purpose study might be nearly indistinguishable from a conventional clinical trial, which MDMA said violates the least burdensome principle.