Researchers from Cornell University are seeking protection for their invention of a low-cost artificial intelligence (AI)-based platform that analyses low resolution electrocardiogram data and/or photoplethysmography data to accurately and objectively assess pain.

Medtronic plc’s next-generation pill-sized camera saw its first use in a recent appointment, during which it captured thousands of high-definition images of the small bowel mucosa. The company hopes that the new Pillcam Genius SB Kit will transform small bowel diagnostics, as it provides clearer imaging, and greater accessibility and ease for both patients and clinicians.

Researchers have developed a novel point of care (POC) diagnostic that can test for multiple respiratory viral infections simultaneously, including for the flu and COVID-19. The POC diagnostic tool leverages a novel, non-enzymatic signal amplification method, according to study lead Eunjung Kim, professor at Incheon National University (INU), whose team published the findings in Sensors and Actuators B: Chemical online November 2024.

Natera Inc., a developer of cell-free DNA testing, provided an update on its product portfolio at the J.P. Morgan Healthcare Conference on Jan. 15. The company disclosed a new version of the Signatera assay that leverages the genome. Natera said the test, now available for research and clinical use, enables bespoke assay design from a whole genome sequence of a patient’s tumor.

Quanterix Corp. plans to merge with Akoya Biosciences Inc., in an all-stock transaction that both companies hope will bolster their fortunes. The transaction will create an integrated solution for ultra-sensitive detection of blood- and tissue-based protein biomarkers.

Researchers from The George Washington University and Northwestern University filed for protection of a bioresorbable, transparent, microelectrode array (MEA) technology that they believe offers unique advantages.

Women with endometriosis may soon be able to have a simple blood test to diagnose their disease thanks to a breakthrough by Proteomics International Ltd. that has developed a plasma protein biomarker panel that identifies all stages of endometriosis.

The question of how skin pigmentation affects the performance of pulse oximeters has drawn the U.S. FDA’s close attention for several years, and the agency issued a draft guidance to address these questions. The draft guidance recommends that new and existing devices be evaluated to establish performance across different pigmentations, a development that would address concerns among clinicians and patients alike.

For more than a decade, HIV remained the only sexually transmitted infection (STI) with U.S. FDA approval of at-home sample collection, but a growing number of tests for sexually transmitted infections have received the regulatory greenlight for patients to swab themselves in the privacy of their own homes in recent years. With STIs reaching levels not seen in decades, regulators and physicians hope that the move will increase diagnostic rates and reduce disease spread by overcoming stigma and access barriers.

South Korea’s Ministry of Food and Drug Safety cleared Acryl Inc.’s Acryl-D01 as the country’s first AI-based digital therapeutic software solution to aid depression screening and diagnosis on Dec. 20. Approved as a class II software as a medical device, Acryl-D01 utilizes a patient’s medical records to quantify and analyze the individual’s emotional response and assess the probability of having clinical depression based on the data.