Medtronic plc snagged FDA premarket approval for its recharge-free implantable neurostimulator (INS), Vanta, for patients with intractable pain. The spinal cord stimulator offers up to 11 years of device life, with optimal programming. That represents a 10% improvement on the Dublin-based company’s previous longest-lasting INS, Primeadvanced, and a near doubling of device life compared to Abbott Laboratories’ Proclaim and Boston Scientific Corp.’s Wavewriter Alpha, using the settings recommended in the clinician manuals. Read More
The FDA granted Neurescue a "two-fer" on its intelligent balloon catheter for aortic occlusion with 510(k) clearance for emergency control of hemorrhage and investigational device exemption for use in cardiac arrest. By inflating a soft balloon at diaphragm level, the device dramatically increases perfusion to the heart, brain and lungs within a minute of deployment via the femoral artery. Read More
Navigation Sciences Inc. has enrolled the initial patient in the first-in-human clinical feasibility trial of the Navisci system designed for surgeons to be able to remove probable early-stage lung tumors in minimally invasive surgery, integrating augmented reality (AR) and advanced software with surgical instruments. Read More
Of all the controversies surrounding the FDA, the agency’s reliance on user fees and its use of accelerated review of therapies might be the most consistent sources of public angst. Coleen Klasmeier, a partner of Sidley Austin LLP, told BioWorld that while she is not particularly concerned about regulatory capture stemming from FDA reliance on user fees, it may be appropriate to ask whether the drug premarket review process leaves FDA staff with more confidence in a new drug application than the data would seem to suggest. Read More
Xenco Medical LLC debuted its glasses-free holographic surgical simulation platform, Holomedx, enabling patients and their surgeons to understand the nuances of spinal procedures before they get underway. The company will begin deploying the virtual reality (VR) training tool for nondiagnostic use at select sites during the week of June 14. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Cerenovus, Foldax, Geneoscopy, Nanomesh, Noctrix Health, Skylinedx. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: 3M, Advanced Human Imaging, Arya III, Autolomous, Avantor, Bio-Techne, C2i, Echonous, Eko, Fittrack, Gynesonics, Inqb8, Intervenn, Nautilus Biotechnology, New England Biolabs, Novogeneait, Paxman Coolers, Peijia, Portal Bioscience, Ritter, Trxade Health, Veranome Biosystems. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Accuray, Avita Medical, Canon Medical, Desktop Health, Medtronic, Neurescue, Nuvo Group. Read More
