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Results for “Device Approval”

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At least 1,045 records · Page 58Linked to original sources
PubMed2002

Uterine artery embolization for the treatment of fibroids.

Uterine artery embolization (UAE), or uterine fibroid embolization, is a non-surgical treatment for uterine fibroids that preserves the uterus and offers women an alternative to surgical procedures such as hysterectomy and myomectomy. Evidence from controlled trials comparing fibroid treatments is not yet available. Case series reports indicate that UAE is a relatively safe and effective treatment for symptomatic fibroids. The effect of UAE on fertility and pregnancy is not known, though pregnancies following UAE have been reported. UAE may reduce health care costs associated with treating fibroids through shorter hospital stays and faster recoveries.

Canada↗
PubMed2002

Hand-carried ultrasound units for point-of-care cardiac examinations.

Several hand-carried ultrasound units have been developed for point-of-care cardiac examination. Limited small comparative studies indicate that these devices are more accurate than physical examination. Though their diagnostic performance is generally inferior to standard echocardiography, there appears to be close agreement for some conditions. Operator training in the performance and interpretation of tests using these ultrasound devices is vitally important. The place of these devices in health care will depend on their compatibility with individual practice, their cost, reimbursement decisions and further technical developments.

Canada↗
PubMed2002

The new FDA combination products programme.

The United States (US) Food and Drug Administration (FDA) has established a Combination Products Programme and developed a new internal procedure to increase its effectiveness in regulating products consisting of combinations of drugs, devices and biological products. This article provides a brief overview of the FDA regulation of combination products and discusses the new Programme.

Biological Products↗
PubMed2002

Stuck in the middle. The highly anticipated drug-eluting stents are good for heart patients, but are they bad for hospital balance sheets?

The Food and Drug Administration stands ready to OK a highly anticipated drug-eluting stent as early as this week, but revenue at hospitals may fall as a result of declining volumes in cardiovascular surgeries, a lucrative service. The problem comes "because hospitals are stuck in the middle," says Jeffery Morneault (left), an executive at Health Alliance of Greater Cincinnati.

Cardiovascular Surgical Procedures↗
PubMed2002

Medical devices; ear, nose, and throat devices; classification of the transcutaneous air conduction hearing aid system. Final rule.

The Food and Drug Administration (FDA) is classifying the transcutaneous air conduction hearing aid system (TACHAS) into class II (special controls). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document that will serve as the special control for the device. The agency is taking this action in response to a petition submitted 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 (FDAMA). The agency is classifying this device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

Device Approval↗
PubMed2002

Bringing new nebulizer technologies to market: regulatory issues.

This review outlines regulatory issues involved in bringing new nebulizer technologies to market and describes the regulatory roles of the Center for Devices and Radiologic Health and the Center for Drug Evaluation and Research. The responsible agency is determined by whether a new device involves a new drug formulation.

Device Approval↗
PubMed2002

Dental devices; classification for intraoral devices for snoring and/or obstructive sleep apnea. Final rule.

The Food and Drug Administration (FDA) is classifying the intraoral devices for snoring and/or obstructive sleep apnea into class II (special controls). These devices are used to control or treat simple snoring and/or obstructive sleep apnea. This classification is based on the recommendations of the Dental Devices Panel (the Panel), and is being taken to establish sufficient regulatory controls that will provide reasonable assurance of the safety and effectiveness of these devices. 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 1976 amendments), the Safe Medical Devices Act of 1990 (the SMDA), and the Food and Drug Administration Modernization Act of 1997 (FDAMA). Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability of the guidance document that will serve as the special control for this final rule.

Dental Devices, Home Care↗