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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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Ethical Ai in Healthcare with Dr. Rodney Gabriel
Background on Dr. Gabriel: Dr. Rodney A. Gabriel is a tenured Associate Professor of Anesthesiology and Associate Adjunct Professor in Biomedical Informatics at the University of California, San Diego. He is the Vice-Chair of Perioperative Informatics and the Medical Director at the Koman Outpatient Pavilion Ambulatory Surgery Center. He graduated medical school at UC San…
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AI in Medtech: Approved Devices and Emerging Opportunities
With the FDA approving an increasing number of AI-powered devices, let’s explore this burgeoning field, highlight current trends, and discuss opportunities yet to be fully realized.
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Tackling the 510(k): An Ambitious Timeline and What It Takes to Succeed
While it’s possible to pursue an aggressive timeline, success requires meticulous planning, robust research, and multiple iterations to ensure the submission meets regulatory expectations.
Articles & events
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