Profusa Receives ISO 13485:2016 Certificate from GMED
The certificate enables manufacturing, while remaining MDR conformity assessments still precede European certification and CE marking.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Summary
Profusa (Nasdaq: PFSA) received its ISO 13485:2016 certificate from GMED for the quality management system covering its Lumee Oxygen Platform. The certificate covers design, development and manufacture of tissue-integrated biosensors and associated readers at its Berkeley, California facility. It follows the positive certification decision announced September 24, 2026, and independently confirms conformity with the medical device quality standard within the certification scope.
Profusa can now begin manufacturing the platform. The company continues working with GMED on remaining European Union Medical Device Regulation (MDR) conformity assessments. Successful completion would support MDR certification and CE marking, which would permit pursuit of EU commercial distribution subject to applicable regulatory and operational requirements.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Hollow bars mark forward-looking points. How the balance works
Positive
- Moderate point. Forward-looking: it has not happened yet and may not happen.Manufacturing can now begin for the Lumee Oxygen Sensor Platform following receipt of the certificate.
- Minor pointISO 13485:2016 certification independently confirms quality-system conformity for Lumee Oxygen design, development and manufacture.
Negative
- Moderate point. Forward-looking: it has not happened yet and may not happen.Remaining MDR conformity assessments must be successfully completed to support MDR certification and CE marking.
- Minor pointISO certification does not constitute FDA clearance or approval or replace applicable FDA regulatory requirements.
Details
Market move: PFSA -4.70% vs previous close. ISO 13485 certification
On Oct 15, the day this news came out, the latest delayed price for PFSA is 4.70% below the previous close. Argus tracked a peak move of +16.4% during the session. Argus tracked a trough of -21.6% from its starting point during tracking. Our momentum scanner has recorded 30 alerts for this stock so far that day. The latest delayed price is $1.22. Relative volume is exceptionally heavy at 226.2x the average.
Data tracked by StockTitan Argus (15 min delayed). Upgrade to Gold for real-time data.
Historical Context
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GMED issued a positive quality-system certification decision; certification was expected in early October.
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Key Terms
iso 13485:2016 regulatory
notified body regulatory
ce marking regulatory
AI-generated analysis. How Rhea-AI works. Not financial advice.
Providing a Foundational Quality Management System (QMS) for Commercialization
- Certificate issued by GMED, an EU MDR notified body, following the positive certification decision previously announced
- ISO 13485 certification supports ongoing MDR conformity assessment activities for the Lumee Oxygen Platform and represents an important milestone toward MDR certification and CE marking.
BERKELEY, Calif., Oct. 15, 2026 (GLOBE NEWSWIRE) -- Profusa, Inc. (Nasdaq: PFSA) ("Profusa" or the "Company"), a digital health company pioneering next-generation biosensor technologies, today announced that it has received its ISO 13485:2016 certificate from GMED, a notified body designated under the European Union Medical Device Regulation (MDR). The certificate covers the design, development and manufacture of the Lumee Oxygen tissue-integrated biosensors and associated readers (the Lumee Oxygen Platform) at the Company's Berkeley, California facility. Its issuance follows the positive certification decision Profusa announced on September 24, 2026.
ISO 13485 is the internationally recognized standard for medical device quality management systems. Certification demonstrates, through independent audit, that Profusa's quality management system conforms to the applicable requirements of ISO 13485:2016 within the scope of certification. ISO 13485:2016 certification is a significant step supporting the Company's ongoing MDR conformity assessment activities for the Lumee Oxygen Platform. ISO 13485 certification is also commonly expected of medical device suppliers during European hospital procurement and distributor qualification processes. CE marking would indicate conformity with applicable EU MDR requirements and permits the Company to pursue commercial distribution in the European Union, subject to satisfying applicable regulatory and operational requirements.
Europe: the foundation for MDR and order fulfillment. A certified quality management system, as demonstrated by Profusa's ISO 13485:2016 certification, is a core element of conformity assessment under the MDR. With the ISO certificate in hand, Profusa continues to work with GMED to complete the remaining MDR conformity assessment activities for the Lumee Oxygen Platform, which, if successfully completed, would support issuance of the MDR certificate and CE marking. Importantly, with the ISO certificate, Profusa can now begin manufacturing the Lumee Oxygen Sensor Platform.
United States: aligned with FDA's quality framework. FDA's Quality Management System Regulation (QMSR), effective February 2, 2026, incorporates ISO 13485:2016 by reference. While ISO 13485 certification does not constitute FDA clearance or approval, nor replace applicable FDA regulatory requirements, it demonstrates conformity with an internationally recognized quality management system standard incorporated into FDA's updated regulatory framework.
"Obtaining ISO 13485 certification provides potential customers, partners, and interested physicians with independent confirmation that Profusa's quality management system conforms to an internationally recognized medical device standard. This certification provides an important foundation as we continue working toward completion of our remaining MDR conformity assessment activities, obtaining MDR certification and CE marking, and preparing for future commercialization in Europe," said Ben Hwang, Ph.D., President of Profusa.
There can be no assurance regarding the timing or outcome of GMED's remaining MDR conformity assessment activities, MDR certification, the timing of CE marking, or the timing of any market entry.
About the Lumee Oxygen Platform
The Lumee Oxygen Platform is designed to provide continuous, real-time monitoring of tissue oxygen levels through Profusa's proprietary tissue-integrated biosensor technology. The platform is intended to provide clinicians with objective tissue perfusion data that may support treatment decision-making and patient monitoring.
About Profusa
Based in Berkeley, California, Profusa is a digital health company developing a new generation of tissue-integrated sensors to detect and continuously transmit actionable, medical-grade data for personal and medical use. With its long-lasting, injectable and affordable biosensors and its intelligent data platform, Profusa aims to provide people with a personalized biochemical signature rooted in data that clinicians can trust and rely on pioneering next-generation biosensor technologies. Profusa previously announced the signing of an Option Agreement (the “Agreement”) which provides Profusa the right and option, but not the obligation, subject to satisfaction of certain conditions, to acquire G3 Vision Labs, Inc. and its subsidiaries (“G3"). Upon option exercising, the combined company is expected to operate as a public diagnostics company.
“LUMEE”, “PROFUSA” and the PROFUSA logo are registered trademarks of Profusa, Inc. in the United States, Canada, European Union, China, Japan, South Korea, and Australia.
For more information, visit https://profusa.com.
Special Note Regarding Forward-Looking Statements
Certain statements in this press release may be considered “forward-looking statements” within the meaning of the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements generally relate to future events or future financial or operating performance of Profusa, including statements regarding the proposed acquisition of G3, and Profusa’s strategic plans. In some cases, you can identify forward-looking statements by terminology such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “forecast,” “future,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “propose,” “seek,” “should,” “strive,” “will,” or “would” or the negatives of these terms or variations of them or similar terminology. Such forward-looking statements are subject to risks, uncertainties, and other factors which may be beyond the control of Profusa and could cause actual results to differ materially from those expressed or implied by such forward-looking statements including, without limitation, risks related to the Company's planned European and U.S. product launches, the risk that such product launches may not result in revenue at the levels anticipated, the risk that customer demand may be less than expected, and risks relating to the Company’s withdrawal of the Registration Statement and conducting a smaller offering of its securities. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Profusa and its management, are inherently uncertain. Profusa cautions you that these statements are based on a combination of facts and factors currently known and projections of the future, which are inherently uncertain. There are risks and uncertainties described more fully in the Company's public filings made by Profusa from time to time with the SEC. These filings may identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Profusa cannot assure you that the forward-looking statements in this communication will prove to be accurate.
Investor and Media Contacts:
Fred Knechtel
fred.knechtel@profusa.com
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What does Profusa’s ISO 13485:2016 certificate cover?
The certificate covers design, development and manufacture of Lumee Oxygen tissue-integrated biosensors and associated readers at Profusa’s Berkeley, California facility. GMED issued it following the positive certification decision announced September 24, 2026.
Does Profusa’s ISO certification mean Lumee Oxygen has CE marking?
No. Profusa is still working with GMED to complete remaining MDR conformity assessment activities. Successful completion would support issuance of the MDR certificate and CE marking; EU commercial distribution would remain subject to applicable regulatory and operational requirements.
How does Profusa’s ISO certification relate to FDA requirements?
ISO 13485 certification demonstrates conformity with a quality management standard incorporated into the FDA framework, but does not constitute FDA clearance or approval. FDA’s Quality Management System Regulation, effective February 2, 2026, incorporates ISO 13485:2016 by reference; certification does not replace applicable FDA regulatory requirements.