With many of the big names in med tech focused on streamlining their portfolios and spinning off divisions as independent companies, M&A activity sputtered through most of 2022. As the year comes to a close, however, deal volume has increased, with a strong trend toward acquisitions of closely related companies and units that bolstered higher-growth product lines and offered short cuts to filling in significant gaps in portfolios. Read More
The U.S. FDA has approved Polarean Imaging plc’s drug-device combination product, Xenoview, for use with magnetic resonance imaging (MRI) in evaluating lung ventilation in adults and children aged 12 and older. The hyperpolarized contrast agent, which is prepared from the Xenon Xe 129 gas blend, is expected to be commercially available in the U.S. starting next month. Read More
After working through a complete response letter (CRL) brought about by COVID-19 from the U.S. FDA in June 2021, Mediwound Ltd. has received the agency’s approval for Nexobrid (anacaulase-bcdb) to treat severe burns in adults. Read More
The CMS had floated a coverage concept for devices routed through the U.S. FDA breakthrough devices program shortly before the Biden administration took office, but the change in administration proved lethal to the program in terms of its initial contours. The latest development in this saga would have the program revert to an expanded use of the existing Medicare coverage with evidence development (CED) program, a far cry from the original concept of same-day coverage upon FDA approval or clearance of the device. Read More
Hemosonics LLC said it was recently awarded U.S. FDA clearance for a new hemostasis test cartridge assay it said significantly expands the indications for clinical use of its existing Quantra system to now also include trauma and liver transplantation procedures. The expanded Quantra hemostasis system with its QStat cartridge will add to capabilities of the system’s QPlus cartridge assay already established in the point-of-care and lab-based, whole blood hemostasis testing market. Read More
Zylox-Tonbridge Medical Technology Co. Ltd. has obtained marketing approval for its retrievable inferior vena cava (IVC) filter Zylox Octoplus in China. “Zylox Octoplus is approved for the prevention of pulmonary embolism (PE) and deep vein thrombosis (DVT) in the peripheral vasculature,” a spokesperson at Zylox-Tonbridge told BioWorld. The approval is based on a multi-center, randomized and positive control clinical trial in China. The trial was conducted in nine peripheral vascular intervention centers in China. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abm Respiratory Care, Mediwound, Vericel. Read More
