Works matching DE "NEW product development laws"

Results: 499

The illusion of safety: A report to the FDA on AI healthcare product approvals.

Published in:

PLoS Digital Health, 2025, v. 4, n. 6, p. 1, doi. 10.1371/journal.pdig.0000866

By:

Abulibdeh, Rawan;
Celi, Leo Anthony;
Sejdić, Ervin

Publication type:

Article

Enrollment and Monitoring of Women in Post-Approval Studies for Medical Devices Mandated by the Food and Drug Administration.

Published in:

2014

By:

Pinnow, Ellen;
Herz, Naomi;
Loyo-Berrios, Nilsa;
Tarver, Michelle

Publication type:

Journal Article

Teaching vascular anatomy: the anatomy we know, the anatomy we see or the anatomy we need?

Published in:

Surgical & Radiologic Anatomy, 2023, v. 45, n. 9, p. 1155, doi. 10.1007/s00276-023-03203-x

By:

Georgakarakos, Efstratios;
Papadopoulou, Myrto;
Karangelis, Dimos;
Fiska, Aliki

Publication type:

Article

FDA permits marketing of point-of-care hepatitis C RNA test.

Published in:: Medical Laboratory Observer (MLO), 2024, v. 56, n. 7, p. 7
Publication type:: Article

FDA clears over-the-counter continuous glucose monitor.

Published in:: 2024
Publication type:: Product Review

Laboratory developed tests part 2.

Published in:

Medical Laboratory Observer (MLO), 2023, v. 55, n. 11, p. 2

By:

Wichmann, Christina

Publication type:

Article

PRODUCT FOCUS :: AACC Round-Up.

Published in:: Medical Laboratory Observer (MLO), 2022, v. 54, n. 10, p. 7
Publication type:: Article

Generalizability of FDA-Approved AI-Enabled Medical Devices for Clinical Use.

Published in:

JAMA Network Open, 2025, v. 8, n. 4, p. e258052, doi. 10.1001/jamanetworkopen.2025.8052

By:

Windecker, Daniel;
Baj, Giovanni;
Shiri, Isaac;
Kazaj, Pooya Mohammadi;
Kaesmacher, Johannes;
Gräni, Christoph;
Siontis, George C. M.

Publication type:

Article

Nonconcurrent Control Use in FDA Approval of High-Risk Medical Devices.

Published in:

JAMA Network Open, 2025, v. 8, n. 4, p. e256230, doi. 10.1001/jamanetworkopen.2025.6230

By:

Mooghali, Maryam;
Dhruva, Sanket S.;
Hakimian, Hollin R.L.;
Rathi, Vinay K.;
Kadakia, Kushal T.;
Ross, Joseph S.

Publication type:

Article

Market of First Launch for High-Risk Therapeutic Medical Devices.

Published in:

JAMA Network Open, 2024, v. 7, n. 12, p. e2449298, doi. 10.1001/jamanetworkopen.2024.49298

By:

Kadakia, Kushal T.;
Lalani, Christina;
Kramer, Daniel B.;
Orui, Hibiki;
Yeh, Robert W.

Publication type:

Article

US FDA Advisory Panel Members' Assessment of Premarket Approval Process and Suggestions for Improvement.

Published in:

JAMA Network Open, 2024, v. 7, n. 10, p. e2436066, doi. 10.1001/jamanetworkopen.2024.36066

By:

Alam, Murad;
Shi, Victoria J.;
Maisel-Campbell, Amanda;
Cressey, Brienne D.;
Nadir, Umer;
Koza, Eric;
Haq, Misha;
Ahmed, Areeba;
Ma, Melissa S.;
Weil, Alexandra;
Cahn, Brian A.;
Lee, Angela Y.;
Shapiro, Sidney;
Poon, Emily

Publication type:

Article

Vagus Nerve Stimulation with Essential Oils: A Brief Review.

Published in:

International Journal of Professional Holistic Aromatherapy, 2023, v. 11, n. 4, p. 37

By:

Mortensen, Jamie

Publication type:

Article

U.S. Congress Members Call for Overdue Review, Enforcement of E-Cigarettes Still on Market.

Published in:

ONS Voice, 2023, p. 2

By:

Stone, Alec

Publication type:

Article

Formal Rules in Product Development: Sensemaking of Structured Approaches.

Published in:

Journal of Product Innovation Management, 2009, v. 26, n. 5, p. 502, doi. 10.1111/j.1540-5885.2009.00677.x

By:

Christiansen, John K.;
Varnes, Claus J.

Publication type:

Article

From the Editor.

Published in:

2009

By:

Anthony Di Benedetto, C.

Publication type:

Letter

Early Results With a New Endovenous Radiofrequency Ablation Catheter, Venclose®.

Published in:

Vascular & Endovascular Surgery, 2022, v. 56, n. 8, p. 743, doi. 10.1177/15385744221110440

By:

Vulakh, Gennady;
Segal, Rianna;
Hingorani, Anil P.;
Ascher, Enrico;
Marks, Natalie

Publication type:

Article

"I Can Help You If You Would Just Let Me!": The Journey From Vendor to Trusted Partner An Interview with Demetrius Carter.

Published in:

AMWA Journal: American Medical Writers Association Journal, 2021, v. 36, n. 4, p. 173, doi. 10.55752/amwa.2021.92

By:

Henzel, Diana

Publication type:

Article

So, You Think You Know About Medical Devices?

Published in:

AMWA Journal: American Medical Writers Association Journal, 2019, v. 34, n. 2, p. 66

By:

Bentley, Shepard;
Johnson, Melory;
Pantry, Shara N.

Publication type:

Article

Posters on Display at the 2014 AMWA Annual Conference.

Published in:: AMWA Journal: American Medical Writers Association Journal, 2014, v. 29, n. 3, p. 127
Publication type:: Article

MEDICAL DEVICES: POLICY AND POLITICS.

Published in:

2013

By:

Hudson, Jim

Publication type:

Proceeding

Early feasibility studies in the United States: Focus on electrophysiology.

Published in:

Journal of Cardiovascular Electrophysiology, 2023, v. 34, n. 10, p. 2158, doi. 10.1111/jce.15869

By:

Weiss, J. Peter;
Farb, Andrew

Publication type:

Article

An early look at a new leadless pacemaker.

Published in:

2023

By:

Hauser, Robert G.

Publication type:

Editorial

Amplatzer Amulet™ left atrial appendage occluder: A step‐by‐step guide to device implantation.

Published in:: Journal of Cardiovascular Electrophysiology, 2022, v. 33, n. 8, p. 1881, doi. 10.1111/jce.15420
Publication type:: Article

The problematic lag between FDA approval of medical devices and CMS coverage.

Published in:

Journal of Cardiovascular Electrophysiology, 2021, v. 32, n. 7, p. 1801, doi. 10.1111/jce.15112

By:

Knight, Bradley P.;
Deering, Thomas F.;
Gold, Michael R.;
Mittal, Suneet;
Singh, Jagmeet P.

Publication type:

Article

Renewing the Call for Reforms to Medical Device Safety-The Case of Penumbra.

Published in:

2022

By:

Kadakia, Kushal T.;
Beckman, Adam L.;
Ross, Joseph S.;
Krumholz, Harlan M.

Publication type:

journal article

Assessment of FDA Approval for New High-risk Therapeutic Devices Not Meeting Pivotal Study Primary End Points, 2016-2020.

Published in:

2021

By:

Johnston, James L.;
Dhruva, Sanket S.;
Ross, Joseph S.;
Rathi, Vinay K.

Publication type:

journal article

Publication of Clinical Studies Supporting FDA Premarket Approval for High-Risk Cardiovascular Devices Between 2011 and 2013: A Cross-sectional Study.

Published in:

2016

By:

Phillips, Adam T.;
Rathi, Vinay K.;
Ross, Joseph S.

Publication type:

journal article

A European regulatory pathway for Tidepool loop following clearance in the United States?

Published in:

Diabetic Medicine, 2024, v. 41, n. 4, p. 1, doi. 10.1111/dme.15246

By:

Downey, Laura;
O'Donnell, Shane;
Melvin, Tom;
Quigley, Muireann

Publication type:

Article

Rethinking the safety and efficacy assessment of (Hybrid) Closed Loop systems: Should we promote the need for a minimum of exercise data within the regulatory approval?

Published in:

2024

By:

Moser, Othmar;
Pemberton, John S.

Publication type:

Editorial

Do‐it‐yourself closed‐loop systems for people living with type 1 diabetes.

Published in:

Diabetic Medicine, 2020, v. 37, n. 12, p. 1977, doi. 10.1111/dme.14321

By:

Dowling, L.;
Wilmot, E. G.;
Choudhary, P.

Publication type:

Article

Understanding Drug Development: A Primer on the Food and Drug Administration.

Published in:

Journal of the Pediatric Infectious Diseases Society, 2021, v. 10, n. 10, p. 977, doi. 10.1093/jpids/piab023

By:

Purandare, Amol V

Publication type:

Article

Physician-Patient Communication about Novel Drugs and High-Risk Medical Devices.

Published in:

Medical Decision Making, 2025, v. 45, n. 2, p. 156, doi. 10.1177/0272989X241302096

By:

Dhruva, Sanket S.;
Kesselheim, Aaron S.;
Woloshin, Steven;
Ji, Robin Z.;
Lu, Zhigang;
Darrow, Jonathan J.;
Redberg, Rita F.

Publication type:

Article

The New Product Safety Law.

Published in:

Challenge (05775132), 1973, v. 16, n. 3, p. 59, doi. 10.1080/05775132.1973.11469988

By:

Swit, David

Publication type:

Article

The Possibilities of a Regulatory Approach to Answer the Question: Should Genetic Inventions be Patentable?

Published in:

2012

By:

DENT, CHRIS

Publication type:

Opinion

Legislating to Exclude Gene Patents: Difficult and Unhelpful, or Useful and Feasible?

Published in:

2012

By:

NICOL, DIANNE;
LIDDICOAT, JOHN

Publication type:

Opinion

A modular, deep learning-based holistic intent sensing system tested with Parkinson's disease patients and controls.

Published in:

Frontiers in Neurology, 2023, p. 1, doi. 10.3389/fneur.2023.1260445

By:

Russell, Joseph;
Inches, Jemma;
Carroll, Camille B.;
Bergmann, Jeroen H. M.

Publication type:

Article

Standalone medical device software: The evolving regulatory framework.

Published in:

2015

By:

McCarthy, Avril D.;
Lawford, Patricia V.

Publication type:

journal article

첨단 디지털 헬스케어 의료기기를 진료에 도입할 때 평가원칙.

Published in:

Journal of the Korean Medical Association / Taehan Uisa Hyophoe Chi, 2018, v. 61, n. 12, p. 765, doi. 10.5124/jkma.2018.61.12.765

By:

박 성 호;
도 경 현;
최 준 일;
심 정 석;
양 달 모;
어 홍;
우 현 식;
이 정 민;
정 승 은;
오 주 형

Publication type:

Article

Immunologic tolerance: the good, the bad, and the ugly.

Published in:

2001

By:

Schenck, K;
Kiyono, H;
Helgeland, K;
Steinsvoll, S;
Taylor, B

Publication type:

Editorial

Expert Recommendations on Frequency of Utilization of Common Laboratory Tests in Medical Inpatients: a Canadian Consensus Study.

Published in:

2019

By:

Ambasta, Anshula;
Pancic, Stefana;
Wong, Brian M.;
Lee, Todd;
McCaughey, Deirdre;
Ma, Irene W. Y.

Publication type:

journal article

Who is responsible for evaluating the safety and effectiveness of medical devices? The role of independent technology assessment.

Published in:

2008

By:

Feldman, Mitchell D.;
Petersen, Amy J.;
Karliner, Leah S.;
Tice, Jeffrey A.

Publication type:

journal article

Trial registration for public trust: making the case for medical devices.

Published in:

2008

By:

Sim, Ida

Publication type:

journal article

Screening and Scheduling of Complex Implantable Devices.

Published in:

Radiologic Technology, 2025, v. 96, n. 3, p. 202

By:

Burch, Marisa L.

Publication type:

Article

The Push for a Smaller, Cheaper, Portable MR.

Published in:: Radiologic Technology, 2020, v. 91, n. 3, p. 288
Publication type:: Article

Professional Review. Advantages and Disadvantages of Screening Breast Ultrasonography.

Published in:

Radiologic Technology, 2016, v. 87, n. 4, p. 455

By:

Warner, Lisa

Publication type:

Article

Researchers Use Open-Source Software to Fuse PET and MR Data.

Published in:: Radiologic Technology, 2014, v. 85, n. 6, p. 682CT
Publication type:: Article

Special Feature: The acoustic safety of new ultrasound technologies.

Published in:

2010

By:

Martin, Kevin

Publication type:

Journal Article

US Food and Drug Administration Approval of Whole Slide Imaging for Primary Diagnosis: A Key Milestone Is Reached and New Questions Are Raised.

Published in:

Archives of Pathology & Laboratory Medicine, 2018, v. 142, n. 11, p. 1383, doi. 10.5858/arpa.2017-0496-CP

By:

Evans, Andrew J.;
Bauer, Thomas W.;
Bui, Marilyn M.;
Cornish, Toby C.;
Duncan, Helena;
Glassy, Eric F.;
Hipp, Jason;
McGee, Robert S.;
Murphy, Doug;
Myers, Charles;
O'Neill, Dennis G.;
Parwani, Anil V.;
Rampy, B. Alan;
Salama, Mohamed E.;
Pantanowitz, Liron

Publication type:

Article

Comes Digital Pathology.

Published in:

Archives of Pathology & Laboratory Medicine, 2015, v. 139, n. 8, p. 972, doi. 10.5858/arpa.2015-0083-ED

By:

Allen, Timothy Craig

Publication type:

Article

Digital Pathology and Federalism.

Published in:

Archives of Pathology & Laboratory Medicine, 2014, v. 138, n. 2, p. 162, doi. 10.5858/arpa.2013-0258-ED

By:

Allen, Timothy Craig

Publication type:

Article