Breaking Update
Israel’s MeMed Wins FDA Breakthrough Status for AI-Powered Infection Test
Haifa-based MeMed's AI-powered MeMed BV Flex test, distinguishing bacterial from viral infections in 15 minutes, earns FDA Breakthrough Device Designation.
Jerusalem, 12 March, 2026 (TPS-IL) — MeMed, an Israeli diagnostics company headquartered in Haifa, has received Breakthrough Device Designation from the U.S. Food and Drug Administration for its AI-powered MeMed BV Flex test. The test uses just a few drops of capillary blood to distinguish bacterial from viral infections in 15 minutes, applying machine-learning algorithms to the body’s immune response.
The FDA designation is aimed at accelerating regulatory review and supporting broader reimbursement coverage, including potential Medicare programs. CEO Eran Eden highlighted the test’s potential to expand access, particularly for children and elderly patients, while improving diagnostic accuracy and reducing unnecessary antibiotic use. The test is not yet approved for sale.
