PubMed Health⌕ Search

SEARCH · PubMed Health

Results for “Device Approval”

Explore indexed PubMed citations for clinical trials, systematic reviews and public health research. Read source abstracts and follow each citation to its original PubMed record.

Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.

At least 631 records · Page 35Linked to original sources

Innovation in medical technology: reading the indicators.

Investment in medical technology innovation has enabled significant advances in patient care. An understanding of the dimensions and measures of innovation is critical in fully assessing the implications of many policy initiatives under debate. This Data Watch presents several indicators of inputs and outputs associated with medical device innovation, including public- and private-sector research and development (R&D) investment, patent activity, product regulatory clearance patterns, and market acceptance trends. Changes in these selected indicators point to a potential shift occurring in both the nature of and the investors in the innovation process.

Device Approval↗

Insurance coverage for experimental technologies.

As the number and cost of new technologies grow, it is increasingly important that we develop sound policies for payment for those technologies while their clinical impacts are being defined. Such policies need to balance social interests in promotion of innovation, early access to promising technology, patient safety, control of health care costs, and return on investment. We present a rationale, policy options, and a proposal for insurance coverage of experimental technology.

Decision Making, Organizational↗

Safety of over-the-counter inhalers for asthma: report of the council on scientific affairs.

The occasional use of over-the-counter (OTC) epinephrine inhalers appears to be safe and effective when used according to labeled instruction by individuals with mild, intermittent asthma. However, gross misuse of these products can cause severe adverse reactions, including death. Limited survey data suggest that approximately 20% of individuals using OTC epinephrine inhalers have mild-to-moderate persistent asthma. According to recent consensus guidelines, these individuals should be under a physician's care and receiving corticosteroid therapy. If these products continue to be marketed, labeling should be strengthened to better educate users about appropriate and inappropriate use of OTC epinephrine inhalers intended for patients with mild, intermittent asthma.

Administration, Inhalation↗

ADA supports vital tooth bleaching--but look for the seal.

The ADA has lent its support to tooth bleaching by providing procedural codes, educational materials and product evaluation procedures. The author describes the elements of the ADA product evaluation process and the role they should play in product development.

American Dental Association↗

Capricious nonsense.

Explore the source record for details and available documents.

American Dental Association↗

High-quality research and patient care: an overview of clinical trials.

BACKGROUND: One of the responsibilities of the dental profession is to protect and advance the well-being of the public through research of new pharmaceuticals and devices. The objective of this article is to present information about the scientific and regulatory process involved in the design and execution of randomized clinical trials. CONCLUSIONS: Dentists willing to serve as investigators in clinical trials--from Phase 1 to Phase 2 or Phase 3--need to be aware of the two main documents that contain the majority of guidelines and regulations governing clinical research: Title 21 of the U.S. Code of Federal Regulations and the guidelines for good clinical practice put forth by the International Conference on Harmonisation. CLINICAL IMPLICATIONS: Advancements in the frontiers of oral health science and the development of safe, innovative and effective treatment modalities are often the result of high-quality clinical research that is conducted by dental professionals. Knowledge of the research process, professionalism, scientific integrity and a detailed execution of the research plan are all required elements for a successful outcome.

American Dental Association↗

The integration of clinical research into dental therapeutics: the role of the astute clinician.

BACKGROUND: Although productive, traditional research approaches may not always address clinically relevant outcomes or translate into changes that can be made in practice. Conversely, clinical observations often result in therapeutic innovations but require verification of safety before widespread use. OVERVIEW: As a strategy for greater integration of research findings and clinical practice, the authors suggest approaches for clinicians to document clinical observations through best case series as a basis for more controlled clinical trials. The aim is to engage clinicians in the process of therapeutic innovation through clinical research. CONCLUSIONS AND PRACTICE IMPLICATIONS: This approach represents a necessary first step for practitioners to formulate hypotheses for further testing, to identify clinically relevant outcome measures and to contribute to the evidence base for clinical practices in dentistry.

Clinical Trials as Topic↗

Lasers in dentistry: separating science from hype.

BACKGROUND: During the last two decades, much has been written in both the scientific literature and the popular press about lasers and their use in the dental office. Both soft- and hard-tissue applications have been discussed, including frenectomy, gingival contouring, caries removal and bleaching. OVERVIEW: Almost one-third of patients surveyed by the American Dental Association in the late 1990s thought it was very important that their dentists have lasers, which could put pressure on dentists to invest in this tool to attract patients. The authors describe the different types of dental lasers and examine the science behind their applications in dentistry. CONCLUSION AND CLINICAL IMPLICATIONS: Although lasers do have legitimate uses in dentistry, they do not take the place of any of the more conventional tools in the dentist's armamentarium. Before investing in a laser, dentists should fully understand the differences between the various types, including what the scientific literature says about their applications.

Dental Caries↗

Dental laboratory technology in crisis, part II: Potential solutions to the challenges facing the industry.

The dental laboratory industry appears to need immediate change to face many challenges, the four most significant of which are described in this column and in our column in May JADA. The first article on this subject described the current challenges facing the laboratory industry, as determined by conference attendees representing all aspects of the dental industry and related professions. This article reports on the suggestions made by attendees of this conference to solve the identified challenges.

Certification↗

ZD1839: targeting the epidermal growth factor receptor in cancer therapy.

The erbB family of receptors, which includes the epidermal growth factor receptor, has been widely implicated in promoting proliferation of malignant cells. The critical role played by epidermal growth factor receptor in cancer has resulted in extensive research for selective inhibitors of the epidermal growth factor receptor signalling pathway. Selective small molecule epidermal growth factor receptor-tyrosine kinase inhibitors, such as ZD1839 (Iressa), block signal transduction pathways implicated in proliferation and survival of cancer cells and other host-dependent processes promoting cancer cell growth. In preclinical studies, ZD1839, alone and in combination with other agents, has demonstrated antitumour activity in a range of tumour types. Results from Phase I trials, in healthy volunteers and in patients with advanced disease, have shown that ZD1839 has excellent bioavailability and an acceptable tolerability profile. In these studies, ZD1839 has also shown promising clinical activity in patients with a variety of tumour types. Furthermore, Phase II studies confirmed clinically meaningful antitumour activity and have demonstrated symptom relief in the second- and third-line treatment of non-small cell lung cancer. Phase III trials are currently evaluating ZD1839 in combination with gemcitabine/cisplatin or paclitaxel/carboplatin as first-line treatment of non-small cell lung cancer and an ongoing clinical trial programme is investigating other tumours (i.e., head and neck, prostate, colon and breast) and other combinations. This article provides an overview of the current profile of ZD1839.

Adult↗