Selux Diagnostics Inc. received U.S. FDA 510(k) clearance for its next generation phenotyping (NGP) system, a rapid antibiotic susceptibility test (AST) platform that determines a bacteria’s susceptibility to 14 specific antimicrobial agents in less than six hours. Prompt identification of the narrowest effective antimicrobial for an infection is critical to the battle to preserve the efficacy of critical antibiotics and slow the development of ‘superbug’ infections.

Deepwise Technology Co. Ltd.'s artificial intelligence (AI) device mammography screening software has been approved in China. The company claims that this is the first and only AI medical device that is approved for breast cancer in China.

Bertis Co. Ltd.’s artificial intelligence (AI)-based diagnosis model is able to detect diseases, such as cancers, with more than 95% accuracy, according to preliminary testing results reported at the Human Proteome Organization 2022 meeting in Cancun, Mexico on Dec. 8.

The latest U.S. Federal Trade Commission (FTC) hearing on the merger between Illumina Inc., and Grail Inc., highlighted some sharp disagreements over the impact of the transaction on the market for multi-cancer early detection (MCED) tests, but Illumina has vowed to take steps to blunt any such effects in an open offer.

Haystack Oncology Inc. has launched with a $56 million series A round to commercialize technology using circulating tumor DNA (ctDNA) to detect minimal residual disease (MRD) following surgery for early-stage cancers.

Six minutes of walking data collected by a smartphone sensor could provide population level health screening, researchers reported in PLOS Digital Health. The study tracked more than 100,000 people as they went about their day wearing activity monitors similar to motion sensors used in smartphones. The sensors captured information on intensity from short burst of walking to predict five-year mortality risk, independent of age and sex.

Oncores Medical Pty Ltd. reported positive data from its first in-cavity trial of its quantitative micro-elastography (QME) imaging system, a hand-held imaging tool that helps surgeons differentiate between cancerous and healthy breast tissue at the point of surgery.

Just as the U.S. FDA gathered industry leaders to address the issues posed by pulse oximeters that provide inaccurate measurements for individuals with darker skin, Biointellisense Inc. released its own FDA-cleared technology that provides accurate readings regardless of skin tone. The challenge of inaccurate readings for people with darker skin came to the fore with the COVID-19 pandemic as fingertip pulse oximeters emerged as a convenient method of monitoring for hypoxia at home and in clinics, but frequently overreported oxygen levels in the blood of people of color, leading to delayed treatment.

A U.S. FDA advisory panel saw a number of problems in the clinical trial for the Avertd test for opioid use disorder (OUD), including the fact that the study failed to enroll a sufficiently ethnically diverse body of subjects. Perhaps more damning was that the advisory panel was uncertain as to whether the 15 single nucleotide polymorphisms (SNPs) evaluated in the test were helpful in sorting out which patients were truly at high risk of OUD, leading to an 11-2 vote that the probable benefits of the test do not outweigh the risks.