Shanghai United Imaging Healthcare Co. Ltd. went public in the Shanghai Stock Exchange STAR Market and raised ¥11 billion (US$1.6 billion) in its initial public offering. Read More
Precision Diabetes Inc. (PDI) entered an exclusive agreement with Dxgen Corp. to introduce and distribute the Epithod Autodx point-of-care analyzer and multiple diabetes tests that run on the system within the U.S. The first available tests will include hemoglobin A1c, C-reactive protein and albumin, with the portfolio of tests expected to grow quickly. Read More
Medical device product liability litigation can take a number of seemingly unique twists and turns, but the case of Nelson v. Bard took a path that might have been predicted based on FDA-mandated labeling content. The U.S. Court of Appeals for the Fifth Circuit affirmed a lower court’s ruling that the instructions for use for a Bard inferior vena cava filter indemnified the company because the IFU listed the very events seen by the patient, undercutting the patient’s claim that Bard had failed to warn of these events. Read More
After nearly four decades as director of the U.S. NIH’s National Institute of Allergy and Infectious Diseases (NIAID), 81-year-old Anthony Fauci will be stepping down in December. He also announced Aug. 22 that he will be handing over the reins as chief of the NIAID Laboratory of Immunoregulation and as chief medical adviser to President Joe Biden. Read More
Regenerative medicine company Avita Medical Ltd. reported that topline results were mixed for its pivotal trial evaluating the safety and effectiveness of its Recell system combined with meshed autograft for reducing donor skin harvesting in soft tissue reconstructions. Read More
A team of researchers from France has started subjecting e-health applications marketed in France to a new scoring tool. This involves rapidly assessing the relevance and potential of software solutions in the medical sector. The results of their study have been published this summer in the Journal of Medical Internet Research (JMIR). Read More
The U.S. FDA has identified a recall of Medtronic cardiac electrophysiology devices as a class I event due to the risk of an inadequate delivery of energy to restore normal rhythm, a recall that affects more than 87,700 units in total. Dublin-based Medtronic plc., said, however, that it is developing a software patch that will remedy the issue, a fix the company said will emerge in late 2022. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Bausch, Medalliance, Sharps Compliance. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Insulet, Pillar Biosciences, Thermedical. Read More
