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At least 325 records · Page 18Linked to original sources
PubMedDate not supplied

Laser root canal therapy.

BACKGROUND: In January 2002, the Food and Drug Administration approved the Er,Cr, YSGG laser for complete endodontic therapy. CASE DESCRIPTION: The author presents a case of a 45-year-old male requiring interceptive endodontic therapy of tooth #21 for the fabrication of an overdenture. The YSGG laser was used for access, debridement, and shaping of the canal. CLINICAL IMPLICATIONS: The YSGG laser is the first-ever approved by the FDA for complete endodontic therapy. Laser therapy may provide clinical improvements in pain control and disinfection during endodontic therapy.

Chromium↗
PubMed2003

OraSure begins shipping rapid HIV test to hospitals. CLIA waiver could come in several months.

Long desired and long delayed, the first truly rapid HIV test is now available in many U.S. hospitals. The simple, 20-minute test, which uses fingerstick whole blood, was categorized as one of moderate complexity under the Clinical Laboratory Improvement Amendment. However, the tests aren't approved for use in the field where they are needed most. That soon may change if the FDA adopts a waiver requested by the manufacturer.

AIDS Serodiagnosis↗
PubMed1995

Observational versus randomized medical device testing before and after market approval--the atherectomy-versus-angioplasty controversy.

Percutaneous transluminal coronary angioplasty was developed in the late 1970s as a nonsurgical alternative for revascularization of atherosclerotic coronary arteries. It gained widespread acceptance without a controlled trial. Introduced in 1986, directional coronary atherectomy was the first of other recently developed coronary devices that sought to improve on the results of angioplasty. It was approved in 1990 by the Food and Drug Administration (FDA) on the basis of observational data. Its use expanded rapidly, reaching over 35,000 procedures in 1992, accounting for more than 10% of all interventions. After premarket approval, two major randomized trials tested the hypothesis that atherectomy would be superior to angioplasty. Their results raised a cautionary flag and stood in contrast to projections made from prior observational data. It is concluded that randomized controlled trials validate claims of relative efficacy and safety of competing medical technologies, a lesson reflected in recent changes in policy at the FDA.

Angioplasty, Balloon, Coronary↗
PubMed2004

[Atomoxetine for the treatment of attention-deficit/hyperactivity disorder].

Atomoxetine is a selective noradrenaline reuptake inhibitor that has been studied for use in the treatment of attention-deficit/hyperactivity disorder (ADHD). In vitro, ex vivo and in vivo studies have shown that atomoxetine is a highly selective antagonist of the presynaptic norepinephrine transporter with little or no affinity for other noradrenergic receptors or other neurotransmitter transporters or receptors. So far, two open-label and seven randomised, double-blind, placebo-controlled, clinical trials have been published, six in youths and three in adults. Each of these trials has shown a positive response as measured by the primary efficacy measures, the ADHD-IV Rating Scale (ADHD RS) or the Conners Adult ADHD Rating Scale (CAARS). Atomoxetine has generally been well tolerated. The most common treatment-related adverse event was decreased appetite. Atomoxetine shows no abuse potential and is not a controlled substance in the US. In November of 2002 the FDA approved atomoxetine for use in the US for the treatment of ADHD in children, adolescents and adults. Atomoxetine is the first nonstimulant approved by the FDA for the treatment of ADHD and the first medication approved for the treatment of adult ADHD.

Adolescent↗
PubMed2000

Gastroenterology-urology devices; effective date of requirement for premarket approval of the penile inflatable implant. Food and Drug Administration, HHS. Final rule.

The Food and Drug Administration (FDA) is issuing a final rule to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the penile inflatable implant, a generic type of medical device intended for the treatment of erectile dysfunction. This regulation reflects FDA's exercise of its discretion to require PMA's or PDP's for preamendments devices and is consistent with FDA's stated priorities and Congress' requirement that class III devices are to be regulated by FDA's premarket review. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the amendments), the Safe Medical Devices Act of 1990, and the Food and Drug Administration Modernization Act of 1997.

Device Approval↗
PubMed2004

Severe ostial saphenous vein graft disease leading to acute coronary syndromes following proximal aorto-saphenous anastomoses with the symmetry bypass connector device: is it a suture device or a "stent"?

The Symmetry Bypass Connector (St. Jude Medical, St. Paul, Minnesota) is a nitinol, star-shaped device that was designed to facilitate placement of sutureless aorto-saphenous anastomoses during off-pump coronary artery bypass graft surgery (CABG). Although the device is approved for clinical use in Europe and the U.S., its short- and long-term safety and efficacy are not established. We report on 5 of 121 patients undergoing CABG who presented with an acute coronary syndrome two to five months following placement of this device. In each patient, all saphenous vein grafts (SVGs) placed (n = 11) with the device were totally occluded (n = 6) or compromised by ostial stenoses (n = 5). Treatment consisted of repeat CABG in one patient and percutaneous coronary intervention (PCI) in four patients with cutting balloon atherotomy and stenting. Following PCI, two of four patients presented again within two months with near-occlusive ostial restenosis in all stents placed. Intracoronary ultrasound showed severe neointimal hyperplasia, but only at the proximal interface of the device and stent. One patient was treated with brachytherapy in two SVGs but had a recurrence four months later and was treated with drug-eluting stents in both restenotic segments. Recalcitrant neointimal hyperplasia is postulated to be involved in the pathogenesis of anastomotic device stenosis, possibly similar to in-stent restenosis. Prospective randomized clinical trials are needed to assess the clinical safety and efficacy of this device. Pending such studies, consideration should be given in limiting its use to cases of unacceptably high risk of stroke during aortic cross-clamping. Dual antiplatelet agents, evaluation for ischemia, and close follow-up are warranted in patients that have already received the device.

Acute Disease↗
PubMed1999

General and plastic surgery devices; effective date of requirement for premarket approval of the silicone inflatable breast prosthesis. Department of Health and Human Services (HHS), Public Health Service (PHS), Food and Drug Administration (FDA). Final rule.

The Food and Drug Administration (FDA) is issuing a final rule to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the silicone inflatable breast prosthesis, a generic type of medical device intended to augment or reconstruct the female breast. This device is made of a silicone shell that is inflated with sterile isotonic saline. Commercial distribution of this device must cease unless a manufacturer or importer has filed with FDA a PMA or PDP for its version of the silicone inflatable breast prosthesis within 90 days of the effective date of this regulation. This regulation reflects FDA's exercise of its discretion to require PMA's or PDP's for preamendments devices and is consistent with FDA's stated priorities and Congress' requirement that class III devices are to be regulated by FDA's premarket review. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the amendments), the Safe Medical Devices Act of 1990, and the Food and Drug Administration Modernization Act of 1997.

Breast Implants↗
PubMed2002

Vagus nerve stimulation therapy summary: five years after FDA approval.

With more than 16,000 patients implanted with the vagus nerve stimulation (VNS) therapy system (Cyberonics, Inc., Houston, Texas), VNS therapy has assumed an increasingly important role in the treatment of medically refractory seizures since its approval 5 years ago by the United States FDA. This review discusses the clinical trials that provided evidence for the approval, long-term efficacy, efficacy in special populations and co-morbid conditions, and safety and tolerability. Additional studies are suggested to further explore the capabilities of VNS therapy.

Device Approval↗
PubMed1997

Quantitative fit testing techniques and regulations for tight-fitting respirators: current methods measuring aerosol or air leakage, and new developments.

Until a few years ago, only two quantitative fit testing (QNFT) techniques were available and accepted by U.S. Occupational Safety and Health Administration (OSHA) regulations. In the 1980s and 1990s, several new and fundamentally different QNFT methods were developed. Two of the newer methods are commercially available and are accepted by OSHA as suitable alternatives. In this article the principles of operation of the OSHA-accepted and of some newly developed but not yet approved QNFT techniques are explained, and each technique's major advantages and disadvantages are pointed out. Emphasis is given to negative-pressure air-purifying respirators, as they are in most frequent use today. The requirements and recommendations for fit testing positive-pressure respirators are discussed as well. Finally, the presently available QNFT standards and regulations are summarized to assist the user in making fit testing decisions.

Aerosols↗
PubMed2006

Comparison of the physical and mechanical properties of MTA and portland cement.

This study evaluated and compared the pH, radiopacity, setting time, solubility, dimensional change, and compressive strength of ProRoot MTA (PMTA), ProRoot MTA (tooth colored formula) (WMTA), white Portland cement (WP), and ordinary Portland cement (OP). The results showed that PMTA and Portland cement have very similar physical properties. However, the radiopacity of Portland cement is much lower than that of PMTA. The compressive strength of PMTA was greater than Portland cement at 28 days. The major constituent of PMTA is Portland cement. Given the low cost of Portland cement and similar properties when compared to PMTA, it is reasonable to consider Portland cement as a possible substitute for PMTA in endodontic applications. However, industrially manufactured Portland cement is not approved currently for use in the United States and therefore no clinical recommendation can be made for its use in the human body. Further in vitro and in vivo tests, especially with regards its biocompatibility, should be conducted to ascertain if it meets the FDA requirements for use as a medical device.

Aluminum Compounds↗
PubMedDate not supplied

A US Food and Drug Administration perspective on cardiac resynchronization and ventricular assist device trials.

Cardiac resynchronization therapy and ventricular assist devices are two of the many US Food and Drug Administration-regulated medical device technologies that are intended for patients with heart failure. Cardiac resynchronization therapy devices have been shown to significantly improve the quality and potentially the duration of life for patients with moderate-to-severe congestive heart failure and electrical dyssynchrony. Likewise, ventricular assist devices have benefited patients with end-stage heart failure through both bridge-to-transplant and destination therapy. The pivotal trials that supported the first approvals for these devices, as well as subsequent trials, were shaped by unique technologic and patient-related concerns. The US Food and Drug Administration has worked to understand these evolving concerns and the role each should play in the design of trials intended to demonstrate the safety and effectiveness of these critical devices.

Cardiac Pacing, Artificial↗
PubMed2001

Regulatory affairs as they affect invasive cardiology.

Over the last several years, the United States Food and Drug Administration (FDA) has significantly improved the time required for the approval of PMA and PMA supplement applications. By the year 1999, the average approval time for PMA applications was 12 months and the average approval time for PMA supplements was only 4 months. In spite of this improved performance by the FDA, it is still advantageous for many products to have their first clinical trial outside the United States.

Cardiology↗
PubMedDate not supplied

CR digital mammography: an affordable entry.

CR full-field digital mammography (FFDM) has been used extensively in other countries, and it was one of the 4 digital mammography technologies employed in the Digital Mammographic Imaging Screening Trial. Affordability and easy integration with pre-existing mammography systems makes CR FFDM an attractive way to secure the advantages of filmless mammography imaging. CR mammography is true digital mammography--it is merely a different way of acquiring the image. The FDA has recently approved the first CR FFDM system for sale in the United States. At Gundersen Lutheran Health System (La Crosse, Wisconsin), CR FFDM is the most practical technology for realizing the potential everyday clinical benefits of filmless mammography imaging.

Device Approval↗
PubMed2000

Novel flexible bronchoscope and single-use disposable-sheath endoscope system. A preliminary technology evaluation.

OBJECTIVE: To measure image clarity, ease of use, and handling performance of a flexible fiberoptic bronchoscope (B-F 100; Vision Sciences; Natick, MA) and sterile single-use disposable-sheath endoscope system (BS-F21 EndoSheath; Vision Sciences). DESIGN: Prospective, multicenter diagnostic technology evaluation of a medical device newly approved by the US Food and Drug Administration. SETTING: Three tertiary care referral centers with busy bronchoscopy practices. PATIENTS: Twenty-four patients undergoing bronchoscopy with a flexible fiberoptic bronchoscope and disposable sheath endoscope system. METHODS: Flexible bronchoscopy was performed through a transnasal or transoral route after topical upper airway anesthesia using standard techniques. After each procedure, the bronchoscopist rated the performance of the medical device under study using a linear scale of 1 (poor) to 5 (excellent and equal to that of a conventional flexible fiberoptic bronchoscope). RESULTS: Mean performance ratings were > 4.0 (range, 4.17 to 4.63) for image clarity, illumination, lack of fogging, distal tip angulation, and ease of transnasal passage. All other ratings were > 3.0 (range, 3.54 to 3.87), the lowest of which was handling comfort. CONCLUSION: The flexible fiberoptic bronchoscope with sterile single-use disposable-sheath endoscope system has the potential to reduce scope downtime by eliminating the need for high-level disinfection between procedures. Illumination, image clarity, and ease of insertion are very good, justifying future prospective studies comparing this device to conventional flexible fiberoptic bronchoscopes.

Bronchoscopes↗
PubMed2005

Placement of the Essure permanent birth control device with fluoroscopic guidance: a novel method for tubal sterilization.

An effective transcervical method for fluoroscopically guided fallopian tube occlusion has long been sought for female sterilization. The Essure permanent birth control device was approved by the Food and Drug Administration in November 2002 and is currently indicated for hysteroscopic placement. In a series of eight patients, bilateral Essure microcoils were placed with fluoroscopic guidance in seven patients for a success rate of 87.5%. One patient described peri- and postprocedure pelvic pain, otherwise no complications were identified. All patients returned to normal activities within 24 hours. Fluoroscopically guided transcervical tubal sterilization with the Essure microcoil device (Conceptus, San Carlos, CA) is a viable outpatient procedure.

Adult↗
PubMed2002

Computer-aided detection and diagnosis at the start of the third millennium.

Computer-aided diagnosis has been under development for more than 3 decades. The rate of progress appears exponential, with either recent approval or pending approval for devices focusing on mammography, chest radiographs, and chest CT. Related technologies improve diagnosis for many other types of medical images including virtual colonography, vascular imaging, as well as automated quantitation of image-derived metrics. A variety of techniques are currently employed with success, likely reflecting the variety of imagery used, as well as the variety of tasks. Most areas of medical imaging have had efforts at computer assistance, and some have even received FDA approval and can be reimbursed. We anticipate that the rapid advance of these technologies will continue, and that application will broaden to cover much of medical imaging. Acceptance of, and integration of computer-aided diagnosis technology with the electronic radiology practice is a current challenge. These challenges will be overcome, and we expect that computer-aided diagnosis will be routinely applied to medical images.

Colonography, Computed Tomographic↗
PubMed2006

Strategic planning for U.S. premarket approval submissions.

The United States premarket approval (PMA) process is costly and time-consuming and differs in important ways from the CE-marking process. This article discusses the importance of strategic planning for submission of a PMA and the issues that should be considered, which can lead to a reduction in the time and cost involved.

Device Approval↗