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.

Hyperfine Inc. gained CE mark approval for the latest generation of its artificial intelligence-powered software for its Swoop portable magnetic resonance imaging system, under the European Medical Device Regulation.

The U.S. Government Accountability Office has rejected an appeal by MCI Diagnostics Inc. regarding a contract bid with the Department of Veterans Affairs despite the company’s assertion that the VA pricing mechanism is flawed.

Ifast Diagnostics Ltd. raised $6.5 million (£5 million) in seed funding to bring its rapid Antimicrobial Susceptibility Testing (AST) platform to the market. The company’s technology is vital in the fight against antimicrobial resistance and the funds will be used to conduct clinical trials to get the product to the market in the U.K., U.S. and EU, CEO Toby King, told BioWorld.

The first patenting from Fibra Inc. sees its founder and CEO Parnian Majid describe their development of a non-invasive wearable device which tracks fertility data through the measurement of various physiological parameters.

Prognomiq Inc. secured $34 million in a series D funding round to advance development of an early detection test for lung cancer based on its multiomics platform. The blood-based test could provide an alternative to the underutilized low-dose CT scans currently recommended for individuals at high-risk of lung cancer.

Qiagen NV added to its growing roster of panels cleared by the U.S. FDA in 2024 with the agency’s nod for its Qiastat-Dx Meningitis/Encephalitis assay. The clearance validates Qiagen’s strategy of developing rapid tests specifically for the U.S. market and builds on the respiratory, gastrointestinal and central nervous system tests already available.