HeartBeam Appoints Deborah Castillo as Vice President of Regulatory Affairs
August 08 2023 - 8:31AM
Business Wire
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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version on businesswire.com: https://www.businesswire.com/news/home/20230808931326/en/
Investor Relations Contact: Chris Tyson Executive Vice
President MZ North America Direct: 949-491-8235 BEAT@mzgroup.us
www.mzgroup.us
Media Contact: media@heartbeam.com
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