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. Read More
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. Read More
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. Read More
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. Read More
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. Read More
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New hires and promotions in the med-tech industry, including: Caron Products and Services, Cerus Endovascular, Delfi Diagnostics, Kelyniam Global, Suvoda, Xhealth. Read More
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. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Ancora Heart, Aurora Spine, Eko. Read More
