Experienced Biomedical Engineer Brings 12+ Years’ Experience in Regulatory Affairs and Quality Assurance for Medical Devices and Diagnostics with FDA and in the Private Sector
HeartBeam, 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.
Castillo 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.
In 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.
“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.”
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.”
About HeartBeam, Inc.
HeartBeam, Inc. (NASDAQ: BEAT) is a cardiac technology company that has developed the first and only 3D-vector ECG platform intended for patient use at home. By applying a suite of proprietary algorithms to simplify vector electrocardiography (VECG), the HeartBeam platform enables patients and their clinicians to assess their cardiac symptoms quickly and easily, so care can be expedited, if required. HeartBeam AIMIGo™ is the first and only credit card-sized 12-lead output ECG device coupled with a smart phone app and cloud-based diagnostic software system to facilitate remote evaluation of cardiac symptoms. By collecting 3D signals of the heart’s electrical activity, HeartBeam AIMIGo has the potential to provide unparalleled data for the development of AI algorithms. HeartBeam AIMIGo has not yet been cleared by the US Food and Drug Administration (FDA) for marketing in the USA or other geographies. For more information, visit HeartBeam.com.
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