Rapid point-of-care (POC) diagnostics company Lumos Diagnostics Holdings Pty. Ltd. has had its hopes of entering the U.S. market dashed yet again following a second decision from the FDA that Febridx has not demonstrated substantial equivalence to the predicate device identified in its 510(k) application.
Japan’s Ministry of Health, Labour and Welfare (MHLW) has given Intuitive Surgical Inc. the green light for its Da Vinci SP surgical system. The surgical system has been cleared for use in general surgeries, thoracic surgeries (excluding cardiac procedures and intercostal approaches), urologic surgeries, gynecological surgeries, and trans-oral head and neck surgeries.
Novo Nordisk A/S received marketing approval from China’s NMPA for its smart insulin pen Novopen Six that automatically collects and stores the date and time of injections and the number of units of insulin that users take.
Koutech Medical Robotics (Shanghai) Co. Ltd. reported it has raised “hundreds of millions of yuan” in a series A round to support the development of its surgical robot. The round is led by Qiming Venture Partners.
With FDA 510(k) clearance of its Kinguide robotic-assisted surgical system, Point Robotics Medtech Inc became the first robotics company in Taiwan to gain U.S. clearance for an orthopedic surgical robot.
Abiomed Inc., has worked the ventricular assist device (VAD) space for a number of years with its Impella series of VADs, and a study coming out of Japan seems to affirm investors’ confidence in these devices. This registry study demonstrated that the combination of Impella devices and extracorporeal membrane oxygenation (ECMO) provides a 30-day survival rate of more than three in four patients with cardiogenic shock, an outcome that is said to support the notion that the native heart tissue can recover from myocarditis, an especially salient consideration for those who contracted the SARS-CoV-2 virus.
Scientists from the University of Queensland have created a new antibiotic that can neutralize various gram-positive bacteria in mice, including major threats such as methicillin-resistant Staphylococcus aureus (MRSA). In a recent study, published in the Sept. 14, 2022, issue of Science Translational Medicine, the new compound outperformed the approved antibiotic vancomycin, and destroyed tough-to-eradicate bacterial biofilms while prompting a low rate of resistance.
The University of Texas MD Anderson Cancer Center and Radiopharm Theranostics Ltd. have launched Radiopharm Ventures LLC, a joint venture (JV) that will develop radiopharmaceutical therapies for cancer. Radiopharm Theranostics owns 51% of shares in the new entity, while MD Anderson owns 49%.