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HeartBeam Appoints Deborah Castillo as Vice President of Regulatory Affairs
Experienced Biomedical Engineer Brings 12+ Years’ Experience in Regulatory Affairs and Quality Assurance for Medical Devices and Diagnostics with FDA and in
About this update from Heartbeam, Inc.
[{"type":"text","content":"\nExperienced Biomedical Engineer Brings 12+ Years’ Experience in Regulatory Affairs and Quality Assurance for Medical Devices and Diagnostics with FDA and in the Private Sector\n\n\n SANTA CLARA, Calif.--(BUSINESS WIRE)--\nHeartBeam, Inc. (NASDAQ: BEAT), a cardiac technology company that has developed the first and only credit card-size 3D-vector electrocardiogram (VECG) platform for patient use at home, allowing for the creation of rich data for AI, today announced the appointment of Deborah Castillo, PhD, as Vice President of Regulatory Affairs.\n\n\nCastillo is an experienced biomedical engineer with extensive knowledge of Food and Drug Administration (FDA), EU, and Health Canada regulations. She has significant expertise in cardiovascular diseases and neuroscience, and medical devices that support these functions. Prior to joining HeartBeam, Deborah was Director of Regulatory Affairs Neuromodulation, at LivaNova, a global medical device company creating neuromodulation devices and cardiopulmonary products, developing and implementing the regulatory strategies for various Class III devices. From 2012 to 2018 Deborah held various roles at the FDA including Acting Branch Chief, Senior Lead Reviewer, and Lead Scientific Reviewer overseeing and conducting various file reviews of program-specific projects including original 510(k)s, PMAs, IDEs, HDEs, De Novo, Pre-cert and Digital Health submissions encompassing a wide-range of cardiovascular and neurological medical devices. She holds a PhD in Biomedical Engineering from The Johns Hopkins University and a BS in Biomedical Engineering from the University of Miami.\n\n\nIn her new role, Castillo will be responsible for leading HeartBeam’s regulatory affairs function and overseeing the company’s interactions with regulatory agencies worldwide. She will also support the company’s clinical development and commercialization efforts for its novel HeartBeam AIMIGo™ Platform Technology, which is currently under review by the FDA.\n\n\n“We are privileged to have Deborah join HeartBeam as a strong addition to our senior leadership team,” said Branislav Vajdic, Ph.D., CEO and Founder of HeartBeam. “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.”...