In a first, the U.S. FDA accepted an artificial intelligence (AI)/machine learning-model into its Innovative Science and Technology Approaches for New Drugs (ISTAND) pilot program for drug development. The program will support use of Deliberate AI Inc.’s anxiety and depression assessment tool, called the AI-generated Clinical Outcome Assessment (AI-COA), as a qualified drug development tool. Read More
Cyted Ltd. received U.S. FDA 510(k) clearance for its Endosign capsule technology, a non-endoscopic capsule sponge device used to collect pan-esophageal samples to detect esophageal pre-cancer and other conditions. The company believes that the minimally invasive test will be able to help prevent deaths from esophageal cancer when offered as a screening test to people on long-term medication for heartburn. Read More
The story of how pigmentation affects the accuracy of pulse oximetry is still in play in the U.S. even though the FDA issued guidance on the subject in 2013, but the latest advisory hearing on the subject has added a new confounder to the story. Read More
Fraud on federal health programs often revolves around illicit billings for in vitro diagnostics, but the U.S. Department of Justice (DOJ) has added mobile cardiac positron emission tomography (PET) to the list of technologies that have been used to violate the law. Read More
South Korea’s CU Medical Systems Inc. has applied for protection of a system that combines features of a cardiopulmonary resuscitation (CPR) device and an automatic external defibrillator (AED) and uses chest impedance measurements to optimize emergency treatment. Read More
New hires and promotions in the med-tech industry, including: Amplity, Amplitude Vascular, Avalere, Beckman Coulter, Femasys, Matica Bio, PHC Holdings. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Biosense Webster, Boston Scientific, Graymatters Health. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Autonomix, Bariatek, Body Vision, C2i Genomics, Dnanexus, Element Biosciences, Hugemed, Rehabtronics, Thermo Fisher, Twist Bioscience, Ultrasight, Veracyte, Xlife Sciences. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Qure.ai, Philips, Stimlabs, Zynex. Read More
