HeartBeam (Nasdaq:BEAT) announced today that it appointed Deborah Castillo as its VP of regulatory affairs.
Castillo, an experienced biomedical engineer, brings with her knowledge of the FDA, EU and Health Canada regulations, HeartBeam says. Her experience spans cardiovascular diseases, neuroscience and medical devices that support these functions.
Before joining HeartBeam, Castillo served as director of regulatory affairs for neuromodulation at LivaNova. From 2012 to 2018, she held a number of roles at the FDA including acting branch chief, senior lead reviewer and lead scientific reviewer.
In her role at Santa Clara, California-based HeartBeam, Castillo holds responsibilities for interactions with regulatory agencies worldwide. She also supports the company’s clinical development and commercialization efforts for HeartBeam AIMIGo. That platform technology for ECG monitoring remains under review by the FDA.
Castillo said she looks forward to working with HeartBeam to achieve regulatory milestones and deliver on the company’s promise. It aims to provide fast and accurate at-home heart attack detection technology directly to patients. She noted that she’s impressed by the company’s “vision, technology and team.”
“[Castillo] 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,” said Branislav Vajdic, CEO and founder of HeartBeam.
