Elucid Appoints Windi Hary to Lead Regulatory Affairs and Quality Management

Regulatory and quality leader brings decades of global SaMD experience to guide leading AI-powered cardiovascular diagnostic company through growth and expansion

BOSTON--(BUSINESS WIRE)--Elucid, Inc., a leading medical technology company providing physicians with AI-powered imaging analysis software to assess cardiovascular disease, has hired Windi Hary as senior vice president (SVP) of regulatory affairs and quality management. Windi’s vast, global experience in software-as-a-medical device (SaMD) and AI-enabled digital health will be central to Elucid’s growth and expansion of its unique product offerings and additional first-of-its-kind innovations in its pipeline.

Elucid’s software is the only FDA-cleared non-invasive tool able to accurately characterize arterial plaque, simulating what pathologists would see under a microscope and establishing a histologic ground truth. The company is also pursuing an indication for FFR_CT, uniquely derived from its PlaqueIQ^® technology, to non-invasively measure coronary blockages and the extent of ischemia. These two capabilities enable precise decision-making by physicians to support prediction and prevention of heart attacks.

“It is my pleasure to welcome Windi Hary to the Elucid leadership team,” said Blake Richards, chief executive officer, Elucid. “Not only does Windi bring a wealth of expertise, acumen, and experience in regulatory and quality management, but she is also a natural fit with Elucid’s culture. We are confident she will make an immediate impact to our regulatory efforts, both in the U.S. and abroad, to ensure we deliver the most effective, impactful, and safe software we can in the fight against cardiovascular disease.”

Hary has more than two decades of regulatory and quality management experience. She brings with her immense knowledge and proficiency in regulatory strategy, particularly for SaMD and AI-enabled digital health, having led and consulted on regulatory filings, design and quality management for U.S., Canada, Japan, and European Union regulatory requirements. She spent more than 12 years at HeartFlow, most recently as chief regulatory and quality officer. Prior to that, Hary spent eight years at Philips Healthcare. She has also consulted for numerous companies on global regulatory strategies, regulatory submissions, quality system implementation, strategic planning, and human factors testing.

Hary is the latest addition to Elucid’s leadership team, joining Dr. Todd Villines, chief medical officer, Scott Burger, chief commercial officer, and Andrew Miller, chief technology officer. This proven, highly accomplished C-suite was strategically curated to guide Elucid through major milestones as it commercializes its plaque analysis software and prepares to expand with its investigational FFR_CT solution.

“The opportunity to join Elucid was extremely exciting to me due to its incredible software, as well as its corporate culture and remarkable team,” said Hary. “From day one, I am committed to working with the rest of the leadership team – and entire company – to ensure that our regulatory, development, and commercial efforts are rigorous so we can achieve Elucid’s mission to fight cardiovascular disease.”

About Elucid

Elucid is a Boston-based medical technology company dedicated to bringing precision patient care, as currently practiced in oncology, to cardiology. Its AI-powered imaging analysis software is designed to deeply understand the root cause of cardiovascular disease. Elucid's plaque analysis software is powered by PlaqueIQ^®, the only FDA-cleared computed tomography angiography (CTA) algorithm that objectively quantifies plaque morphology validated against tens of thousands of tissue samples by renowned pathologists. Elucid is also pursuing an indication for FFR_CT, uniquely derived from its PlaqueIQ^® technology, to non-invasively measure coronary blockages and the extent of ischemia. PlaqueIQ^® equips physicians with critical information for assessing the risk of plaque rupture in arteries that can lead to heart attack and stroke. The Elucid plaque analysis software is available for commercial use in the U.S. and South Korea. For more information, visit elucid.com.