Zuckerman B - Search Results

1

The medical device development ecosystem: Current regulatory state and challenges for future development: A review.

Holmes DR Jr, Farb A, Dib N, Jacques L, Rowe S, DeMaria A, King S, Zuckerman B. Holmes DR Jr, et al. Among authors: zuckerman b. Cardiovasc Revasc Med. 2024 Mar;60:95-101. doi: 10.1016/j.carrev.2023.09.005. Epub 2023 Sep 27. Cardiovasc Revasc Med. 2024. PMID: 37778922 Review.

2

Interventional cardiology live case presentations: regulatory considerations.

Farb A, Brown SA, Wolf DA, Zuckerman B. Farb A, et al. Among authors: zuckerman b. Catheter Cardiovasc Interv. 2010 Oct 1;76(4):E126-9. doi: 10.1002/ccd.22718. Catheter Cardiovasc Interv. 2010. PMID: 20862708

3

Clinical Perspective--Early Feasibility Device Medical Studies in the United States: Time for More Than Regulatory Reform.

Holmes DR Jr, Shuren J, Califf R, Zuckerman B, Abel D, Farb A, Leon M, Mack M. Holmes DR Jr, et al. Among authors: zuckerman b. JACC Cardiovasc Interv. 2016 Mar 28;9(6):626-8. doi: 10.1016/j.jcin.2016.02.004. JACC Cardiovasc Interv. 2016. PMID: 27013168 Free article. No abstract available.

4

The 21st Century Cures Act and Early Feasibility Studies for Cardiovascular Devices: What Have We Learned, Where Do We Need to Go?

Holmes DR Jr, Hance R, Syrek Jensen TS, Schwartz DA, Kaplan A, Farb A, Zuckerman B, Leon M, Waklowiak J, Mack MJ, Shuren J. Holmes DR Jr, et al. Among authors: zuckerman b. JACC Cardiovasc Interv. 2018 Nov 12;11(21):2220-2225. doi: 10.1016/j.jcin.2018.05.010. JACC Cardiovasc Interv. 2018. PMID: 30409280 Free article. Review.

5

Overcoming the Challenges of Conducting Early Feasibility Studies of Medical Devices in the United States.

Holmes DR Jr, Califf R, Farb A, Abel D, Mack M, Syrek Jensen T, Zuckerman B, Leon M, Shuren J. Holmes DR Jr, et al. Among authors: zuckerman b. J Am Coll Cardiol. 2016 Oct 25;68(17):1908-1915. doi: 10.1016/j.jacc.2016.07.769. J Am Coll Cardiol. 2016. PMID: 27765194 Free article. Review.

6

Clinical event adjudication in cardiovascular device trials: An Food and Drug Administration perspective.

Farb A, Zuckerman BD. Farb A, et al. Am Heart J. 2017 Sep;191:62-64. doi: 10.1016/j.ahj.2017.05.010. Epub 2017 May 23. Am Heart J. 2017. PMID: 28888271 No abstract available.

7

Early Feasibility Studies for Cardiovascular Devices in the United States: JACC State-of-the-Art Review.

Holmes DR Jr, Farb AA, Chip Hance R, Leon MB, Goldberg P, Zuckerman BD, Kaplan AV, Rincon-Gonzalez L, Hunt J, Walkowiak J, Mack MJ. Holmes DR Jr, et al. Among authors: zuckerman bd. J Am Coll Cardiol. 2020 Dec 8;76(23):2786-2794. doi: 10.1016/j.jacc.2020.10.019. J Am Coll Cardiol. 2020. PMID: 33272373 Free article. Review.

8

Patent Foramen Ovale after Cryptogenic Stroke - Assessing the Evidence for Closure.

Farb A, Ibrahim NG, Zuckerman BD. Farb A, et al. N Engl J Med. 2017 Sep 14;377(11):1006-1009. doi: 10.1056/NEJMp1700218. N Engl J Med. 2017. PMID: 28902595 No abstract available.

9

Interventional cardiology live case presentations: regulatory considerations.

Farb A, Brown SA, Wolf DA, Zuckerman B. Farb A, et al. Among authors: zuckerman b. J Am Coll Cardiol. 2010 Oct 5;56(15):1283-5. doi: 10.1016/j.jacc.2010.08.601. J Am Coll Cardiol. 2010. PMID: 20883943 Free article. No abstract available.

10

Live case demonstration of interventional cardiology procedures: a regulatory perspective.

Farb A, Zuckerman B. Farb A, et al. Among authors: zuckerman b. JACC Cardiovasc Interv. 2012 Feb;5(2):225-7. doi: 10.1016/j.jcin.2011.11.006. JACC Cardiovasc Interv. 2012. PMID: 22361608 Free article. No abstract available.

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