Eyenuk Inc. is significantly extending the scope of its artificial intelligence system for the automatic analysis of retinal images, adding the diagnosis of age-related macular degeneration (AMD) and glaucoma to the EU approved uses of Eyeart AI.
The U.S. FDA inked a Dec. 20, 2022, warning letter to Righteye LLC that handed the company a list of quality system issues in dire need of redress, but the agency was more concerned about off-label promotion of the Righteye vision system as a method for evaluating the patient’s ocular tremors as a sign of Parkinson’s disease.
Aktiia SA’s wrist-worn, continuous blood pressure monitor, which has been in use in the EU since 2021, could soon be coming to the U.S. The Aktiia bracelet uses photoplethysmography, the technology perhaps best known for providing blood oxygenation readings via pulse oximeters, and an algorithm based on thousands of readings to estimate blood pressure as wearers go about their daily activities.
The COVID-19 pandemic provided opportunities for companies that provide telehealth solutions, and Taiwan-based Faceheart Inc has developed video-based measurement software that allows patients to be screened remotely using artificial intelligence (AI).
Perspectum Diagnostics Ltd. reported the first close at $36 million of its series C round, with the majority of the new money due to be invested in expanding U.S. uptake of its Livermultiscan diagnostic for assessing and monitoring chronic liver disease.
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.