DENVER, Colo. (247marketnews.com) — Profusa (NASDAQ:PFSA) is moving closer to a potentially important commercial inflection point for its Lumee Oxygen Platform after receiving a positive decision from GMED regarding certification of its quality management system to ISO 13485, the international quality-management standard for medical devices.
The September 24 development matters because Lumee Oxygen remains under European Union Medical Device Regulation conformity assessment with GMED, the notified body overseeing the process. Profusa says ISO 13485 certification is expected in early October, while additional MDR assessment work remains before the company can obtain the applicable MDR certificate and pursue CE marking.
“We are pleased with the progress we have made in strengthening our quality management system,” President Ben Hwang said, calling the decision “a significant milestone for Profusa” and pointing to the team’s work addressing GMED’s observations.
This is progress toward CE marking, not CE marking itself. Profusa’s own regulatory page currently lists the Lumee Oxygen Platform as undergoing conformity assessment, with CE certification “under review with GMED.”
The backdrop makes the announcement more consequential. Profusa has spent 2026 working through the MDR process, including a June response package addressing GMED questions involving technical documentation, quality-system evidence, clinical evaluation and validation information. The company’s platform is designed to continuously monitor tissue oxygen through an injectable, tissue-integrated biosensor, with applications including critical limb ischemia and wound care. Profusa says the system is intended to give clinicians objective tissue-perfusion data in real time.
There is also a broader corporate story developing. In August, Profusa reported progress toward its option to acquire G3 Vision Labs, while disclosing $719,000 in cash at June 30, $28.2 million in total liabilities and a $12.2 million first-half net loss. The company also reported that $10.7 million of debt and liabilities holders had executed Series A Convertible Exchange Agreements.
That leaves investors watching two clocks: the regulatory clock for Lumee Oxygen and the corporate-financing/execution clock surrounding G3.
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