NEWSROOM
News and milestones
Zera Medical is currently completing FDA clearance and preparing for its U.S. clinical pilot launch. Updates will be posted here as milestones are reached.
LATEST
COMPANY LAUNCH
Zera Medical launches ZeraMed.com, introducing ZeraFlow to investors, clinicians, and patients across the United States.
Zera Medical today launched ZeraMed.com, the company's primary digital home as it advances ZeraFlow toward FDA clearance and U.S. commercial launch. The site introduces ZeraFlow to three audiences simultaneously: investors evaluating the current SAFE round, GI clinicians and ASC administrators interested in the upcoming U.S. pilot program, and patients seeking an alternative to traditional at-home bowel preparation.
MARCH 2026
COMPANY MILESTONES
2024
Zera Medical LLC founded
U.S. entity established to commercialize ZeraFlow for the North American market.
COMPLETE
2026
ZeraMed.com launches
Company website live. SAFE round in progress. Pilot site recruitment underway.
COMPLETE
2026
FDA 510(k) submission and clearance
Class II 510(k) submission in progress. Clearance anticipated Q2–Q3 2026.
IN PROGRESS
POST CLEARANCE
U.S. clinical pilot launch
Flagship pilot with 1–3 leading GI practices or ASCs. Target: approximately 1,000 procedures.
UPCOMING
2013
2022–2025
2027
Peer-reviewed publication
Ziv Y, Scapa E. Techniques in Coloproctology. Foundational clinical study published.
500+ international clinical procedures completed
ZeraFlow validated across more than 500 procedures in Israel with no serious adverse events.
U.S. outcomes publication and regional expansion
U.S. pilot data prepared for peer-reviewed publication. Expansion to 5+ centers.
COMPLETE
COMPLETE
UPCOMING
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