Articles & events
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SE.ai Joins SCbio: Advancing Life Sciences in South Carolina
We are thrilled to announce that SE.ai has been accepted into SCbio, South Carolina’s premier life sciences organization dedicated to fostering innovation and growth in the industry. This milestone marks an exciting step forward for us as we join a vibrant community committed to transforming healthcare and improving lives through science and technology. SCbio’s mission
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Navigating the 510(k) Premarket Notification Process: A Deep Dive into Predicate Device Selection
By Leon Zheng, Co-founder & CSO Introduction The U.S. Food and Drug Administration (FDA) plays a critical role in ensuring the safety and efficacy of medical devices entering the market. Among the regulatory pathways available, the 510(k) premarket notification process is the most commonly used, accounting for over 80% of FDA medical device clearances
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SE.ai joins SCRA as a member company
From https://www.scra.org/scra-announces-new-member-companies-and-grant-funding-mar25/ SCRA Announces New Member Companies and Grant Funding Columbia, S.C. – LCIX, Matty AI, and SE.ai were accepted as South Carolina Research Authority Member Companies. Agricarbon US, Bio Streamline, Blotting Innovations, Green Cape Health, and Lumiq received new grant funding. All SCRA Member Companies receive coaching and access to SCRA’s Member Benefits and Startup Resources, can apply for
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An Open Letter from the CEO of SE.ai
As the medical device regulatory landscape shifts, I know that many of you at the FDA and CDRH are facing uncertain times. The news of job cuts is devastating, especially for those of you who have dedicated your careers to ensuring the safety and efficacy of life-changing medical innovations. I want you to know that…
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The FDA’s Final Rule on LDTs: A Turning Point for MedTech Innovation
Introduction Laboratory-Developed Tests (LDTs) have long been a cornerstone of innovation in diagnostics, enabling laboratories to rapidly respond to unmet clinical needs. From rare disease diagnostics to pandemic preparedness, LDTs have played a vital role in advancing patient care. However, the FDA’s recent final rule issued in May 2024 represents a significant regulatory shift. Under
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