In an unexpected turn of events, Medtronic plc presented results from the Symplicity HTN-3 trial at year 3 showed sustained reductions in blood pressure with radiofrequency renal denervation (RDN) for resistant hypertension, contrary to the trial’s results at the six-month mark—and it wasn’t alone in showing positive results for the procedure. Read More
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. Read More
Lepu Medical Technology (Beijing) Co. Ltd. received marketing approval from China’s NMPA for its peripheral cutting balloon to treat peripheral arterial disease. Read More
EU health ministers have warned that developers of medical devices face trouble ahead in meeting deadlines for implementing the two new key regulations for medical devices (MDR) and in vitro diagnostics (IVDR). These were planned to enter into force in May 2021 and May 2022 respectively. EU executives and stakeholders have now all accepted that delays in complying with the regulations could result in issues achieving certification for medical devices, threatening shortages in the market. Read More
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. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Eko, Elekta, Genome Medical, Karkinos Healthcare, Neurosync, Pieriandx, Revbio, Syncthink. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Insulet, Medtronic, Oswaldo Cruz Foundation, Predicine, Stryker, Zimmer Biomet. Read More
