FDA Approves InspireMD's Application to Initiate Study of Neuro Protection System — Update
By Christopher Kuo
InspireMD said the Food and Drug Administration approved its application to initiate a study of its SwitchGuard neuro protection system.
Shares of the medical technology company rose 27%, to $1.15, in after-hours trading Friday. Ahead of the close, the company's shares were down 38% year to date.
The company also said Friday it expects the FDA to approve its original CGuard stent delivery system for CAS procedures in the U.S. in the third quarter of 2026.
The company said it is voluntarily recalling its CGuard Prime 135 cm carotid stent delivery system for stroke prevention after determining that the system did not meet performance expectations during carotid artery stenting procedures.
The voluntary recall has no implications for the safety of patients who previously received the CGuard stent, the company said.
The company is implementing design improvements to CGuard Prime and expects approval from the FDA by the first half of 2027, the company said.
The company is withdrawing its previously issued full-year revenue guidance.
Write to Christopher Kuo at chris.kuo@wsj.com
(END) Dow Jones Newswires
May 01, 2026 17:14 ET (21:14 GMT)
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