The U.S. medical device industry: entrepreneurs' future hinges on reforms at the Food and Drug Administration.
Explore the source record for details and available documents.
Device Approval↗
SEARCH · Search PubMed
Results for “Device Approval”
Search indexed PubMed citations on genomics, clinical trials, systematic reviews and public health. Explore titles, authors and supplied subject terms, then open the PubMed record.
Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.
Challenging the viability of FDCA-based causes of action in the tort context: the orthopedic bone screw experience.
Explore the source record for details and available documents.
Bone Screws↗
Defining "least burdensome means" under the Food and Drug Administration Modernization Act of 1997.
Explore the source record for details and available documents.
Device Approval↗
IRBs and Humanitarian Device Exemptions (HDEs).
Explore the source record for details and available documents.
Device Approval↗
New lease on life: device re-use gets legitimized. Illinois state senator led push to regulate 'secret' industry of reconditioned devices.
Explore the source record for details and available documents.
Device Approval↗
First-of-a-kind heart device cleared.
Explore the source record for details and available documents.
Device Approval↗
Nociceptive trigeminal inhibition--tension suppression system: a method of preventing migraine and tension headaches.
Dentists and physicians see countless patients suffering from various types of headaches. Various modes of therapy are used in an attempt to treat these patients. As a result of this study, it appears that a common factor to migraine and tension-type headaches may be chronic clenching. If this is the case, then dentists may treat headache patients more effectively than previously suspected through the use of a dental appliance.
Bruxism↗
ADA position on laser for hard tissue procedures. American Dental Association Council on Scientific Affairs.
Explore the source record for details and available documents.
Dental Caries↗
Evaluating the efficacy of 2-octyl cyanoacrylate bioadhesive for treatment of oral ulcerations.
Studies were recently completed that evaluated a novel bioadhesive device for use in treating oral ulcerations. This article reviews the research protocols and results of these studies on the bioadhesive's safety, ability to decrease immediate and long-term pain, effects on ulcer healing, and equivalence to a predicate device in providing pain relief for oral ulcers.
Analgesics↗
Nociceptive trigeminal inhibition--tension suppression system: a method of preventing migraine and tension headaches.
Dentists and physicians see countless patients suffering from various types of headaches. Various modes of therapy are used in an attempt to treat these patients. As a result of this study, it appears that a common factor to migraine and tension-type headaches may be chronic clenching. If this is the case, then dentists may be able to treat headache patients more effectively than previously suspected through the use of a dental appliance.
Acrylic Resins↗
Scheme to sell gas grill igniters for pain relief backfires.
Explore the source record for details and available documents.
Device Approval↗
Wireless capsule endoscopy in obscure digestive tract bleeding.
Explore the source record for details and available documents.
Blue Cross Blue Shield Insurance Plans↗
Lasers use OK receives mixed reaction. IDA awaiting more information.
Explore the source record for details and available documents.
Dental Caries↗
An assessment of the regulations on medical devices in the European Union.
Explore the source record for details and available documents.
Device Approval↗
The evolution of substantial equivalence in FDA's premarket review of medical devices.
Explore the source record for details and available documents.
Device Approval↗
PMA primacy: synthesizing the 35 U.S.C. Section 156 patent term extension, 35 U.S.C. Section 271(e)(1) patent infringement exemption as currently applied to medical devices, and medical device preemption jurisprudence to yield a cohesive solution regarding scope of coverage.
Explore the source record for details and available documents.
Device Approval↗
Quest Diagnostics receives FDA clearance for new Bio-Intact PTH test kit.
Explore the source record for details and available documents.
Device Approval↗
FDA clears new test for rapid identification of breast cancer risk factors.
Explore the source record for details and available documents.
Adult↗