HeartBeam Appoints Dr. Deborah Castillo as VP of Regulatory Affairs

HeartBeam, a cardiac technology company, has appointed Deborah Castillo, Ph.D. as its new vice president of regulatory affairs.
 
Castillo is a biomedical engineer with “extensive knowledge” of U.S. Food and Drug Administration (FDA), EU, and Health Canada regulations. Before joining HeartBeam, she was director of regulatory affairs neuromodulation at LivaNova.
 
From 2012 to 2018, Dr. Castillo had a number of roles at the FDA including acting branch chief, senior lead reviewer, and lead scientific reviewer. In these roles, she oversaw and conducted file reviews of original 510(k)s, PMAs, IDEs, HDEs, De Novo, pre-cert, and digital health submissions for cardiovascular and neurological medical devices.
 
Castillo will lead HeartBeam’s regulatory affairs and oversee company interactions with regulatory agencies across the globe. She will also support clinical development and commercialization for the company’s AIMIGo platform tech, which is currently under FDA review.
 
“We are privileged to have Deborah join HeartBeam as a strong addition to our senior leadership team,” Branislav Vajdic, Ph.D., CEO and founder of HeartBeam, told the press. “She is a seasoned regulatory leader with a proven track record of bringing novel medical technologies to market. Her expertise will be invaluable in leading our regulatory strategy and execution.”
 
Castillo added, “I am honored and excited to join HeartBeam at this pivotal time. I have been impressed by the Company’s vision, technology, and team. I look forward to working with them to achieve our regulatory milestones and deliver on our promise of providing fast and accurate at-home use heart attack detection to patients around the world, bringing lifesaving diagnostic capabilities directly to patients.”