The press release submitted for rewrite concerns InspireMD's CGuard Prime 80 cm carotid stent implant and results from the CGUARDIANS II clinical trial evaluating its use in transcarotid artery revascularization (TCAR) procedures. A PMA (Premarket Approval) supplement is currently under FDA review for potential clearance in H2 2026.

This content does not fall within the editorial scope of Functional News or the broader Food & Beverage Magazine network. CGuard Prime is an implantable medical device regulated under FDA's Center for Devices and Radiological Health (CDRH), not a dietary supplement, functional food, nutraceutical ingredient, or finished formulation subject to DSHEA, GRAS status, or structure-function claim frameworks.

Functional News covers peer-reviewed clinical evidence for bioactive ingredients, novel food technologies, probiotic and prebiotic innovations, botanical standardized extracts, condition-specific nutrition, and regulatory developments from FDA's Center for Food Safety and Applied Nutrition (CFSAN) and Office of Dietary Supplement Programs (ODSP). Coverage of supplement regulation and FDA guidance and clinical trial findings in nutraceuticals are core editorial beats this publication serves.

Submitters are encouraged to review Functional News editorial guidelines before pitching. Relevant content includes ingredient launches, clinical endpoints from double-blind placebo-controlled nutrition trials, bioavailability data, CFU-validated probiotic formulations, NDI notifications, and market-sizing analysis for the functional food and supplement categories.

For medical device industry coverage, please contact the appropriate trade publication within the healthcare technology vertical.

Written by Michael Politz, Author of Guide to Restaurant Success: The Proven Process for Starting Any Restaurant Business From Scratch to Success (ISBN: 978-1-119-66896-1), Founder of Food & Beverage Magazine, the leading online magazine and resource in the industry. Designer of the Bluetooth logo and recognized in Entrepreneur Magazine's "Top 40 Under 40" for founding American Wholesale Floral, Politz is also the Co-founder of the Proof Awards and the CPG Awards and a partner in numerous consumer brands across the food and beverage sector.