Beacon Biosignals Inc. can rest easy now that it has received U.S. FDA authorization of its predetermined change control plan for the Dreem 3s, a wearable sleep monitor that conducts electroencephalograms as users sleep. The authorization allows Beacon to incorporate updates to the Dreem 3S sleep-staging algorithm acquired through machine learning without submitting a new 510(k) application.

An artificial intelligence-powered contactless monitoring device developed by Albus Health Ltd. can detect signs of asthma attacks in children up to five days before they occur.

In what represents the first patenting from Glasgow-based Microplate Dx Ltd., three of its co-founders describe a system for diagnosing microbial infections and performing rapid antimicrobial susceptibility testing, enabling quicker and more precise determination of effective antibiotics.

While women with “big hearts” play well in popular culture, cardiologists see a very different picture – with significant implications for women’s health and medical care. Women have smaller hearts and narrower blood vessels than men and their cardiovascular systems respond to disease and treatment in very different ways. Growing evidence that failure to reflect women’s distinct anatomy in cardiac care leads to deadly disparities in outcomes has recently stimulated development of new diagnostics and increased focus on inclusion of women in medical device trials.

The recent agreement between Devyser Diagnostics AB and Thermo Fisher Scientific Inc. to collaborate to obtain U.S. FDA approval for a next-generation sequencing (NGS) test for kidney transplant monitoring allows the test to be democratized, Fredrik Alpsten, CEO of Devyser to BioWorld.

Researchers from North Carolina State University filed for protection of miniaturized, wireless, wound-monitoring sensors that may be incorporated into swabs or wound dressings for real-time, accurate assessment of wound status.

Many studies have linked the presence of specific bacteria to various diseases. But a general overgrowth of gut bacteria can be a symptom of different conditions, including colorectal cancer and inflammatory bowel disease. A study counting gut microbiome proposes that microbial load, rather than the disease, could explain the presence of certain pathogens.

Smartcardia SA received U.S. FDA clearance for mobile outpatient cardiac telemetry for its seven-lead live ECG monitoring patch and cloud platform. With the approval, the solution can now be used for remote live monitoring of a patient’s ECG and immediately notify clinicians in cases of arrhythmias.

The first filing to emerge from Identifyher Ltd. seeks to gain protection for a wearable sensor that women can wear daily to track potential symptoms of perimenopause, providing them with data that can be used to find the right management plan for their needs.

Artificial intelligence-powered rare disease diagnostics firm 3billion Inc. debuted on the tech-heavy Kosdaq board of the Korea Exchange Nov. 14 with its IPO raising about ₩14.4 billion (US$10.25 million) via an offering of about 3.2 million shares at ₩4,500 per share, the low end of its offering price range.