Orange Biomed to Present New A1C Research at DTM 2026
Orange Biomed will present a scientific poster and join the Startup Showcase at the 26th Annual Diabetes Technology Meeting in Washington, D.C., on Oct. 27-29. The company is using the event to highlight new A1C repeatability research as it advances toward FDA submission and potential over-the-counter clearance for its handheld meter.
Why it matters: - Orange Biomed is using DTM 2026 to showcase progress on a pocket-sized A1C meter designed for home use. - The company is advancing toward a U.S. medical device launch, with ISO 13485 certification already in hand and a planned FDA 510(k) submission ahead. - The meeting gives Orange Biomed direct access to clinicians, researchers and industry partners focused on diabetes care.
What happened: - Orange Biomed said it will participate in the 26th Annual Diabetes Technology Meeting from Oct. 27-29 at the Hyatt Regency Crystal City in Washington, D.C. - The company will present a scientific poster and take part in the Startup Showcase. - Orange Biomed is attending DTM for the fourth consecutive year. - The event is co-hosted by the American Diabetes Association and the Diabetes Technology Society.
The details: - Orange Biomed will present an abstract titled "A Pump-Free Microfluidic Sensor for Highly Repeatable HbA1c Monitoring via Flow-Normalized RBC Velocity Variability." - The poster session is scheduled for Tuesday, Oct. 27, 2026, at 6:35 p.m. EDT in Slot #26. - The Startup Showcase is set for Wednesday, Oct. 28, 2026, from 4:35-6:35 p.m. EDT. - The study builds on repeatability research the company presented as a Late-Breaking Poster at the ADA's 86th Scientific Sessions in June 2026. - Orange Biomed's OBM rapid A1c is a reusable meter that measures A1C from a single 5 µL fingerstick blood sample and is designed to deliver results in five minutes. - The device uses a proprietary microfluidic single-cell analysis platform that measures the characteristics of individual red blood cells. - The approach does not rely on biochemical protein measurement and is less affected by interference from hemoglobin variants. - The reagent-free cartridges can be stored and shipped at room temperature. - The meter requires no recalibration. - Orange Biomed earned ISO 13485 certification for its quality management system in September. - Orange Biomed is preparing a 510(k) submission to the U.S. FDA for potential over-the-counter clearance of the OBM rapid A1c.
Between the lines: - The company is positioning its technology as a simpler alternative to conventional A1C testing, which is usually done in laboratories or clinics. - Repeated appearances at DTM suggest Orange Biomed is using the conference as a key venue for technical validation and business development. - CEO Yeaseul Park said the company wants to make A1C testing more accessible at home and help people manage diabetes more conveniently.
What's next: - Orange Biomed will present its research and meet with potential collaborators during DTM 2026. - The company will continue work toward FDA submission and possible over-the-counter clearance in the U.S. - Further progress on the OBM rapid A1c will likely center on regulatory review and broader market entry.
The bottom line: - Orange Biomed is pairing new A1C data with a clear commercialization push as it looks to turn its microfluidic meter into a home-testing product.
Disclaimer: This article was produced by AGP Wire with the assistance of artificial intelligence based on original source content and has been refined to improve clarity, structure, and readability. This content is provided on an “as is” basis. While care has been taken in its preparation, it may contain inaccuracies or omissions, and readers should consult the original source and independently verify key information where appropriate. This content is for informational purposes only and does not constitute legal, financial, investment, or other professional advice.
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