RegulatoryCompany release

InspireMD wins FDA approval of CGuard Prime for TCAR as Q3 loss narrows

🇺🇸 InspireMD, Inc. (NSPR) · Thu 12 Nov 2026

The US device maker reported Q3 2026 results, with FDA clearance for transcarotid use, a PMA supplement planned for December and a recalled delivery system due back in 2027.

InspireMD said on 12 November 2026 that the US Food and Drug Administration has approved CGuard Prime for transcarotid arterial revascularization (TCAR). The company expects US sales for this use to start in the fourth quarter of 2026.

The announcement came with the company's third-quarter 2026 results. Revenue for the quarter was $2.2m. The company's headline said its net loss narrowed to $9.8m following the recall.

The recall concerned the CGuard Prime carotid artery stenting (CAS) delivery system, which InspireMD withdrew voluntarily in the US in May 2026. The company plans to file a premarket approval (PMA) supplement in December 2026 for a redesigned version of the system. It is targeting relaunch in the first half of 2027.

Cash and marketable securities stood at $19.2m, against $54.2m at the end of 2025. The source material available does not give further detail on the cause of the recall, the scope of the design changes or the drivers of the cash decline.

For context, a PMA supplement is the route by which a manufacturer asks the FDA to approve a change to a device that already holds a premarket approval.

What it means for your team

  • Regulatory teams tracking carotid devices should note that the TCAR approval and the recalled CAS delivery system follow separate pathways, with a PMA supplement for the redesign planned for December 2026.
  • Quality and post-market teams may see this as an example of a voluntary recall followed by a design change and a supplement filing, with relaunch dependent on FDA review.
  • Market-access teams should watch for US TCAR sales starting in Q4 2026 and the relaunch target of the first half of 2027, which are company expectations rather than confirmed dates.

Company's press release (SEC filing): InspireMD, Inc. ↗

Article written by VigiEye from the official source (InspireMD, Inc.). Claims are the company's own. AI-assisted; check the source before acting.

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