Expert Details
Medical Device Business Development, Clinical Trials and Regulatory Strategy, Cardiology, Cardiac Electrophysiology
ID: 725687
Maryland, USA
She is a board certified cardiologist. She has been in both private practice and academic settings. In addition, she has regulated cardiac devices and has also held an industry position with a cardiac device company.
She is a board certified cardiologist and electrophysiologist. She has been in both private practice and academic settings. In addition, she has regulated cardiac devices and has also held an industry position with a cardiac device company that produced electrophysiologic catheters.
She is a board certified cardiologist and electrophysiologist with extensive experience implanting devices. She has been in both private practice and academic settings. In addition, she has regulated cardiac devices and has also held an industry position with a cardiac device company.
She worked for the FDA in CDRH approving IDEs. In addition, she wrote IDEs in industry.
While with industry, she worked with the engineers on developing new product lines.
While with industry, she worked with the team to develop a business strategy for a start-up company.
Education
| Year | Degree | Subject | Institution |
|---|---|---|---|
| Year: 2003 | Degree: MPH | Subject: Clinical Trials | Institution: Johns Hopkins University |
| Year: 1991 | Degree: MD | Subject: Medicine | Institution: University of Rochester |
| Year: 1987 | Degree: ScB | Subject: Psychology | Institution: Brown University |
Work History
| Years | Employer | Title | Department |
|---|---|---|---|
| Years: 2008 to Present | Employer: Undisclosed | Title: Owner | Department: |
Responsibilities:FDA regulatory consulting for medical device companies |
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| Years | Employer | Title | Department |
| Years: 2006 to 2008 | Employer: CryoCor, Inc | Title: Chief Medical Officer | Department: |
Responsibilities:She was responsible for designing and running clinical trial. She obtained FDA approval for the first cryoablation product used for atrial flutter which involved running and FDA panel meeting. She assisted in strategic planning for the company. |
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| Years | Employer | Title | Department |
| Years: 2002 to 2006 | Employer: National Naval Medical Center | Title: Staff Cardiologist Electrophysiologist | Department: |
Responsibilities:She had clinical and teaching responsibilities. |
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| Years | Employer | Title | Department |
| Years: 2000 to 2002 | Employer: FDA | Title: Medical Officer in Office of Device Evaluation | Department: CDRH/ODE/DCD |
Responsibilities:Pacing, Defibrillation and Leads Branch Responsible for first biventricular pacing devices and MADIT |
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Career Accomplishments
| Associations / Societies |
|---|
| ACC, AHA, HRS |
| Licenses / Certifications |
|---|
| Licensure and Certification: American Board of Internal Medicine: Certified in Internal Medicine (1994) Certified in Cardiovascular Diseases (1997) Certified in Clinical Electrophysiology (1998) Virginia License (1997) Maryland License (2000) DC License (2003) |
| Publications and Patents Summary |
|---|
| She has 21 publications in cardiology. Abstracts: 33 |