COVID-19 is the unwanted gift that keeps on giving. The U.S. CDC unwrapped one of those “presents” in a July 12 report that showed the threat of antimicrobial-resistant (AMR) infections has worsened — with resistant hospital-onset infections and deaths in the U.S. each increasing at least 15% during the first year of the pandemic.
Legislation that would renew the U.S. FDA’s user fee programs is stuck in process on Capitol Hill, a predicament that seems to resist resolution to date. FDA commissioner Robert Califf said on a July 12 webinar that the FDA “is a decision-making machine” that is reliant on both user fees and congressional appropriations, and that a failure on the part of Congress to act on user fee legislation may force the agency to halt new hires and possibly lay off some FDA staff.
Sonio SAS raised just over $5 million in its seed round to develop artificial intelligence (AI) software allowing health care professionals to determine the most appropriate pregnancy care. Its Sonio Diagnostic software delivers decision support for fetal ultrasound used in antenatal diagnostics.
The U.S. Federal Trade Commission (FTC) has been moving aggressively on privacy issues in connection with health data in the past two years, but the agency has issued an advisory of sorts to collectors of these data points. The FTC said July 11 that it intends to crack down on violators in an effort to protect data privacy.
The Royal Academy of Engineering in the U.K. is supporting another batch of health care innovations in developing countries, which range from surgical robots to tissue regeneration material. A number of entrepreneurs supported by the Academy’s Leaders in Innovation Fellowships (LIF) Global 2022 program were recently given the additional opportunity to secure further expert mentoring from engineers from the Academy's network and join a peer network of U.K. founders.
Clinical analytics company Medial Earlysign Ltd. is expanding an existing partnership with Roche Holding AG to commercialize an artificial intelligence (AI) solution for the early detection of lung cancer. The companies originally signed an agreement in September to develop a personalized health solution for early detection of gastric cancer. The goal of the new collaboration is to develop Earlysign’s Lungflag software, which uses machine learning to identify patients at risk of developing lung cancer.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Ancora Heart, Aurora Spine, Eko.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abbott, Affidea, Biomerics, Chemimage, Incepto, LG Chem Maxcyte, Medtronic, Milestone Scientific, Selux Diagnostics.
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