Avinger Inc. has received U.S. FDA clearance for a its Ocelaris next-generation, image-guided chronic total occlusion (CTO) crossing system for patients with peripheral artery disease (PAD). The catheter-based system, which will be sold under the brand name Tigereye, provides real-time imaging from within the vessel during a CTO-crossing procedure. It will be available on a limited basis beginning later this year.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Avinger, Cardio-Phoenix.
The rescission order directing the U.S. FDA to abandon regulation of lab-developed tests is scarcely three weeks in the past, but two senior managers at the FDA are pushing back in an editorial appearing in the New England Journal of Medicine. The FDA’s Jeff Shuren and Tim Stenzel wrote that there is “a need for a common legislative framework” to ensure clinical tests are accurate and reliable, which implicitly concedes that the statute does not authorize the agency to regulate lab-developed tests.
PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) said industry stakeholders supported making in vitro diagnostic (IVD) self-tests available for infectious diseases like influenza but self-tests for cancer and genetic testing for health-related purposes should continue to be prohibited from supply.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Boston Scientific, Exsomed, Glaxosmithkline, Innoviva, Izi Medical, Verily.
The second day of the U.S. FDA’s orthopedic devices advisory panel included a proposal to down-classify semi-constrained toe joint prostheses as class II devices, but the panel was adamant that such devices be slotted in class III, with one panelist referring to the literature for these devices as “garbage.”
Minnetronix Medical Inc. has won the U.S. FDA’s nod for its Mindseye Expandable Port for neurosurgical procedures. The company touts the device as the first minimally invasive, retractable deep brain access system for use in the treatment of stroke, cancer and other conditions.
Medtronic plc is celebrating its latest win following the U.S. FDA’s approval of an early feasibility study (EFS) of the Intrepid transcatheter tricuspid valve replacement system in patients with severe, symptomatic tricuspid regurgitation. The action comes after the agency granted breakthrough device designation for the system.
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