Medical Device Tracking
Tracking information may be used to facilitate notifications and recalls ordered by FDA in the case of serious risks to health presented by the devices. The regulations implementing the tracking requirements became effective on August 29, 1993 and can be found in 21 CFR Part 821.
Views: 459
Source: www.fda.gov
FDA Medical Device Malfunction Advisory
Electronic messages posted on the Rx2000 Solutions Institute listserver raise concerns that 15 instruments from seven manufacturers of medical devices will not work correctly after December 31, 1998. The e-mail alleges these products will not be able to accommodate the transition from December 31, 1998 to January 1, 1999.
Views: 224
Source: www.fda.gov
Medical Device Technology Forecast: Discussion
Although a large number of topics emerged from this survey, six major trend categories circumscribe all of the product-type examples. The resulting applications in the clinical community were administrative patient data bases (1970s), computerized medical diagnosis programs (ca.
Views: 212
Source: www.fda.gov
'Talking' Medical Devices, Apps Continue to Evolve – WebMD
Talking portable defibrillators have been around for years, guiding users through the steps of saving a cardiac arrest victim. Other high-tech health tools help teach operating room staffers how to assemble the complicated set-ups of rarely used surgical devices.
Views: 133
Source: www.webmd.com
Questions & Answers on Shelhigh Medical Devices (June 26, 2007)
FDAs June 22, 2007 consent order with Shelhigh, Inc., Union, N.J., has generated interest from the medical community and the general public. This action follows the April 17, 2007, seizure of all implantable devices at Shelhighs Union, NJ manufacturing facility.
Views: 187
Source: www.fda.gov
Buying Medical Devices and Diagnostic Tests Online
The medical devices include such products as hearing aids, contact lenses, magnets, and laboratory diagnostic test kits. Types of medical devices range from thermometers to artificial hearts to at-home pregnancy test kits.
Views: 351
Source: www.fda.gov
Scott Gottlieb, MD - 2005 Medical Innovation Summit
Cardiac medicine is just one of many therapeutic areas virtually transformed by innovations in medical technology. Breakthroughs such as coronary stents, implantable defibrillators and minimally invasive bypass surgery have helped reduce the death rate from heart disease by 40 percent since 1980.
Views: 106
Source: www.fda.gov
Redesigned systems may increase access to MRI for patients with implanted medical devices -…
The novel system is described in a paper published in the online Nature journal Scientific Reports. It is estimated that around 300,000 patients worldwide are prevented from receiving MRI exams each year because of implanted devices.
Views: 115
Source: www.medicalnewstoday.com
How does the FDA 'approve' medical products? - Medical News Today
Scientific evidence from clinical trials must be provided by the manufacturers demonstrating the safety and effectiveness of their product. Over-the-counter drugs are monitored by the FDA, but they are submitted to a less rigorous testing procedure, especially if they are assumed to be safe.
Views: 106
Source: www.medicalnewstoday.com
Medical Devices that Treat Obesity: What to Know
Before a medical device is recommended, doctors will probably want their patients to have tried lifestyle changes that include healthy eating and increased physical activity. Even if a person is prescribed an obesity treatment device, he or she still must make lifestyle changes.
Views: 93
Source: www.fda.gov
Medical Devices News -- ScienceDaily
Additionally, the ... full story Oct. 10, 2014 A novel technique that reduces image degradation caused by respiratory motion during a PET scan was developed through a recent study. PET scanning is routinely used to detect cancer and heart ... full story Oct. 9, 2014 Cardiologists have implanted an investigational cardiac pacemaker the size of a multivitamin.
Views: 184
Source: www.sciencedaily.com
Cybersecurity for Medical Devices and Hospital Networks: FDA Safety Communication
Summary of Problem and Scope: Many medical devices contain configurable embedded computer systems that can be vulnerable to cybersecurity breaches. The FDA has been working closely with other federal agencies and manufacturers to identify, communicate and mitigate vulnerabilities and incidents as they are identified.
Views: 281
Source: www.fda.gov