The Challenges of Clinical Validation of Emerging Technologies: Computer-Assisted Devices for Surgery
- Final Implementation of the Training Module. Welty, Gordon // Journal of GXP Compliance;Spring2009, Vol. 13 Issue 2, p67
This article is the seventh in a series on training and the ADDLE Model. The first article, "Strategy and Tactics of Task Analysis," appeared in the Journal of GXP Compliance (JGXP), Volume 11, Number 3, April 2007; the second appeared as "The 'Design' Phase of the ADDLE Model," Volume 11,...
- Robotic heart surgery technique gets FDA's nod for first multi-center trial. Runy, Lee Ann // AHA News;01/08/2001, Vol. 37 Issue 1, p5
Reports on the approval of a multi-center trial of a robotic heart surgery technique by the United States Food and Drug Administration as of January 2001. How the robotic technology works; Company that created the equipment; Benefits of the system for patients.
- Now communicate with doctors via robots. // Future Medicine;Feb2013, Vol. 2 Issue 2, p9
The article reports on the 510(k) clearance received from the U.S. Food and Administration (FDA) by RP-VITA, which is a robot that allows patients to communicate with doctors via telemedicine system.
- Hansen gets FDA approval for Magellan robotic system. // Medical Device Daily;6/5/2012, Vol. 16 Issue 106, p9
The article reports on the clearance received by Hansen Medical from the U.S. Food and Drug Administration (FDA) for its Magellan Robotic System.
- No fable: FDA clears AESOP, a cardiac endoscopy robot. // Medical Marketing & Media;Feb98, Vol. 33 Issue 2, p20
Announces that the US Food and Drug Administration (FDA) has granted marketing clearance to the Automated Endoscopic System for Optimal Positioning (AESOP) 3000 robotic arm for positioning an endoscope in minimally invasive heart surgery.
- Vdrive Robotic Navigation System from Stereotaxis Inc. // Imaging Economics;Oct2013, Vol. 26 Issue 9, p32
The article reports that the U.S. Food and Drug Administration (FDA) has granted Stereotaxis Inc. with the FDA 510(k) marketing clearance for its Vdrive Robotic Navigation System integrated with the V-Sono Intracardiac Echocardiography (ICE) catheter manipulator in the U.S.
- FDA Drug Approvals. // Formulary;Mar2002, Vol. 37 Issue 3, p112
Reports on the medicines approved by the United State Food & Drug Administration. Identification on the latest medicines; Efficacy of the drug medicines; Indication of the dosage.
- FDA promotes new drug-making technologies. // Medical Marketing & Media;May2002, Vol. 37 Issue 5, p35
Reports on the role of the U.S. Food and Drug Administration (FDA) on facilitating the introduction of process analytical technology in the U.S. Factors prompting the FDA to take the leadership role; Reason of companies on failing to introduce manufacturing technologies; Strategy of the FDA on...
- Latest laser awaiting approval from FDA for hair removal. Bowser, Andrew // Dermatology Times;Jan1998, Vol. 19 Issue 1, p40
Reports on a pending clearance by the Food and Drug Administration (FDA) for the long-pulse alexandrite laser to market as a hair removal system. Approval received from FDA on the use of laser in the treatment of vascular lesions; Characteristics of alexandrite lasers; Efficacy of long-pulse...