James L. Johnston

Clinical Evidence Supporting US Food and Drug Administration Clearance of Novel Therapeutic Devices via the De Novo Pathway Between 2011 and 2019

James L. Johnston, Sanket S. Dhruva, Joseph S. Ross et al. · JAMA Internal Medicine · 2020 · 26 citations · Full text

Pharmacy, Clinical Pharmacy, Pharmacology +12

Medicare’s New Device-Coverage Pathway — Breakthrough or Breakdown?

Vinay K. Rathi, James L. Johnston, Joseph S. Ross et al. · New England Journal of Medicine · 2021 · 24 citations

Public Affairs, Health Law, Health Policy +14

Pulmonary arterial strain- and remodeling-induced stiffening are differentiated in a chronic model of pulmonary hypertension

Mark J. Golob, Diana M. Tabima, Gregory D. Wolf et al. · Journal of Biomechanics · 2017 · 16 citations · Full text

Medicine, Cardiology, Physiology +15

US Food and Drug Administration Approval of Drugs Not Meeting Pivotal Trial Primary End Points, 2018-2021

James L. Johnston, Joseph S. Ross, Reshma Ramachandran · JAMA Internal Medicine · 2023 · 16 citations · Full text

Pharmacy, Pharmacology, Clinical Pharmacology +13

Aligning US Agency Policies for Cardiovascular Devices Through the Breakthrough Devices Program

Osman Moneer, Vinay K. Rathi, James L. Johnston et al. · JAMA Cardiology · 2023 · 15 citations

Public Affairs, Health Law, Health Policy +16