Zimmer Biomet Holdings Inc. has won the FDA’s nod for its Rosa Partial Knee system for robotically assisted partial knee arthroscopy. The new system is the latest addition to the Rosa Robotics platform, which also includes the Rosa Knee system for total knee replacement and Rosa One for neurosurgical and spine procedures. The Rosa Partial Knee system is designed to be compatible with Zimmer’s Personal partial knee. It incorporates 2D to 3D X-Atlas imaging technology and real-time, intraoperative data collection on both soft tissue and bone anatomies to ensure accurate bone cuts and improve range of motion gap analysis. Read More
Safeguard Medical LLC further consolidated its position in the first responder market with the acquisition of H&H Medical Corp. Williamsburg, Va.-based H&H produces military-grade trauma response products for field medics and emergency responders. "Our mission at Safeguard Medical is to equip and enable responders at every skill level to preserve life in any environment. The acquisition of H&H adds another trusted brand to our market-leading portfolio and expands our ability to partner with life-saving responders around the world," said Adam Johnson, Safeguard Medical’s CEO. Read More
The negotiations for the next medical device user fee agreement are well underway, but the FDA is pressing the case for a substantial increase in device user fees. While the controversy over the cost of each addition to the FDA staff has not gone away, the agency continues to compare device user fees to drug user fees even though the drug industry is populated by much larger companies, thus nullifying any such comparisons in the view of device makers. Read More
Prenetics Ltd. is working with Oxford University researchers again to develop molecular diagnostic testing for the new COVID-19 variants, six months after it acquired Oxsed Ltd., a University of Oxford University spinoff to enable rapid airport testing. On April 19, Hong Kong-based Prenetics inked a multimillion-dollar partnership with the University of Oxford and Oxford Suzhou Center for Advanced Research (OSCAR) to upgrade the molecular testing technology Oxlamp for infectious diseases. Read More
PERTH, Australia – In response to the COVID-19 pandemic, Trajan Scientific and Medical Ltd. and Synexa Life Sciences Ltd. have developed and validated a SARS-CoV-2 serology assay that enables more efficient, population-based monitoring of the longevity of COVID-19 vaccines being deployed and to help determine the timing and deployment of booster vaccinations. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Avacta, Co-Diagnostics, Limacorporate, Medtronic, Phagenesis, Renalytix AI, Vivasure Medical. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Amgen, Biocartis, Conformis, Dariohealth, East Agency, Electrocore, Grail, Illumina, Kaiku Health, Mediorbis, Neogenomics, Novartis, Paragon 28, Sanuwave. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Livanova, Spinal Elements, Zimmer Biomet. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA provides path for diagnostic testing using pooled samples; FDA inks warnings for pandemic testing; Recall issued for repaired infusion pumps; NICE launches transformative strategy; NICE launches transformative strategy; Russia expands access to certain pediatric treatments. Read More
Keeping you up to date on recent developments in oncology, including: Research may enable real-time imaging of tumors during PBT treatments; Algorithm may restore raw mammograms from processed images; Hand-held device would check for PSA. Read More
