Nikki Batista

Nikki Batista

Director, Digital Health Regulatory Affairs
Background

Ms. Batista has over eight years of experience and expertise in the healthcare arena. She possesses expertise in engineering research and regulatory affairs for digital health technologies and cardiology devices. Ms. Batista provided oversight of a wide range of cardiac diagnostic devices including, but not limited to, Automatic External Defibrillators (AED), Implantable Cardiac Monitors, Holter Monitors, Patch Devices, 12-Lead ECGs, Patient Monitors, Wearable Technology, Irregular Rhythm Detection Algorithms, and Clinical Decision Support Algorithms.

Ms. Batista contributed to the development and implementation of several transformative policies at the FDA. Notably, Ms. Batista participated in the testing and development of the Digital Health Precertification Program, including the Streamlined Review Program and the Excellence Appraisal process, and the implementation of the Final Order to require PMAs for AED products. 

 
Education

Ms. Batista received her Bachelor of Science degree in Biomedical Engineering at the Rensselaer Polytechnic Institute. She also received her Master’s in Engineering at Rensselaer Polytechnic Institute where she contributed to the development of a synthetic ACL scaffold and electrical stimulation therapy for peripheral nerve damage repair.

Experience

Prior to joining MCRA in 2019, Ms. Batista served as the Assistant Director of the External Heart Rhythm and Rate Device Team where she provided leadership to a multidisciplinary team responsible for reviewing submissions involving the total product lifecycle of the device (Q-submissions, IDEs, 510(k)s, PMAs, Recalls, Complains and Allegations, Establishment Inspection Reports, Medical Device Reports, and Signal Management). Prior to becoming the Assistant Director, Ms. Batista held roles as Senior Lead Reviewer in the Peripheral Intervention Devices Team and Lead Reviewer in the Interventional Cardiology Devices Team where she provided signatory oversight and input on 510(k), PMA, IDE, and Pre-submissions for combination productions and catheter-based technology. Ms. Batista also provided sterilization and packaging consulting reviews to the entire Office of Cardiovascular Device.

Before joining the FDA, Ms. Batista was a Biomedical Engineer at ZetrOZ, LLC where she designed and conducted a neuromodulation study to evaluate a second-generation application for a novel ultrasonic therapeutic device.

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