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Profusa received a positive decision from GMED on ISO 13485 certification, expected in early October, while additional European MDR conformity assessment work remains before the Lumee Oxygen Platform can receive a CE mark. Key Investor TakeawaysProfusa (NASDAQ:PFSA) received a positive decision from notified body GMED regarding certification of its quality management system to ISO 13485.
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Berkeley, CA, Sept. 15, 2026 (GLOBE NEWSWIRE) -- Profusa, Inc. (Nasdaq: PFSA) (the “Company”) announced today that on September 9, 2026, the Company received a letter (the “Compliance Determination Letter”) from The Nasdaq Stock Market LLC (“Nasdaq”) confirming that the Company has demonstrated compliance with Nasdaq Listing Rule 5550(a)(2) (the “Bid Price Rule”) and Nasdaq Listing Rule 5550(b)(1) (the “Equity Rule”). The Company remains subject to a one-year Mandatory Panel Monitor (the “Monito
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