Intervene Inc. received breakthrough device designation from the FDA for its treatment for chronic venous insufficiency (CVI), Blueleaf endovenous valve formation system, which makes new venous valves in the leg using the patient’s own vein tissue. The catheter-based system splits and stretches the vein wall to create a new leaflet. In a recently published study, 14 patients underwent the procedure, of which 13 successfully had at least one new valve created. No patients experienced adverse events during the procedure and no deep venous thromboses developed through a one-year follow up period. Read More
At long last, the FDA has released information on a potential regulatory framework for 3D device printing at the point of care (POC), just the first step in the implicit guidance development process. The document highlights several potential tripwires for device manufacturers and operators of health care facilities, but the large number of complex questions posed by the paper suggests that a final guidance is not likely to arrive any time soon. Read More
With aging populations and more sophisticated markets growing in the Asia Pacific region, multinational corporations including Medtronic plc and Olympus Corp. are tapping digitalization, robotics and innovation platforms to seek med-tech solutions. Read More
TORONTO – Cloud Dx Inc. has entered into an exclusive corporate agreement with Medtronic Canada ULC to provide the subsidiary of Medtronic plc virtual and remote patient monitoring (RPM) technology and services across Canada. Medtronic Canada will begin by integrating Cloud Dx’s Connected Health platform along the perioperative and complex chronic disease pathways that make up the country’s health care network. Read More
Endogena Therapeutics Inc., of San Francisco, has raised another $20 million in a series A funding round to progress a regenerative medicine that could use stem cells to “heal” the damage caused by eye disease retinitis pigmentosa (RP). Read More
New hires and promotions in the med-tech industry, including: Abbott, Cutera, Establishment Labs Holdings, Hyperfine, Inogen, Neogenomics, Nurosene, Turner Imaging. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Baxter, Clearsky, Deep Knowledge Group, Henry Schein, Hillrom, Hospital IQ, Medtronic, Masimo, Omnia, Opsens, Quant Biomarkers, Siemens Healthineers, Shanghai Accurature. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Galderma, Intervene, Urotronic. Read More
