fda news from FierceHealthIT
NewsNew online databases help patients find adverse event
Two health IT startups aim to help patients sift through the reams of adverse event data collected by the U.S. Food and Drug Administration, according to a report today in the Wall Street Journal. Read more...
FDA sued for monitoring employees' personal email accounts
After warning Congress that some medical devices were being approved despite possibly posing a danger to patients, a number of scientists and doctors had their personal email secretly monitored by Read more...
FDA CDS (Cont.)
Examples of Presently Regulated CDS As we mentioned, FDA currently regulates a number of CDS products. Here are a few examples:
Accessory software: Any software marketed to complement the Read more...
FDA's approach to clinical decision support software: A brief summary
We wrote this paper for those who have little experience with U.S. Food and Drug Administration regulation of clinical decision support (CDS) software. Our goal is to provide background for those who Read more...
Kaiser, Mayo press for standard product identifiers to improve patient safety
The Healthcare Transformation Group (HTG), a collaborative comprised of five big healthcare organizations--Geisinger Health System, Intermountain Healthcare, Kaiser Permanente, Mayo Clinic, and the Read more...
Todd Park: More can, should be done to capture unique EHR safety issues
As Chief Technology Officer at the U.S. Department of Health & Human Services, it's Todd Park's job to be excited about innovation. And, as anyone who's seen him speak live can attest, he takes Read more...
IOM proposes new agency to oversee health IT safety
As concern over health IT-related safety issues mounts, the Institute of Medicine (IOM) has proposed the creation of a new watchdog agency to monitor these problems. This agency would investigate Read more...
'Human factor' often overlooked in home health device creation
The National Research Council believes that home health device manufacturers don't give enough consideration to human factors like ease of use when creating their technology, according to a report Read more...
AAMI research focuses on technology management in hospitals
The Technology Management Council of the Association for the Advancement of Medical Instrumentation (AAMI) has launched a study of technology management in healthcare facilities and hospitals. The Read more...
Intel-GE gets FDA approval for Intel Health Guide
Intel-GE Care Innovations, a joint venture of Intel and GE, has received U.S. Food and Drug Administration 510(k) clearance for the Intel Health Guide Express. This is a software solution that Read more...
| Press ReleasesAbbott's STARLIMS LIMS Technology to be Installed in FDA Testing LaboratoriesABBOTT PARK, Ill., Jan. 18, 2012 /PRNewswire/ -- Abbott (NYSE: ABT) announced today that the U.S. Food and Drug Administration (FDA) will begin implementing Abbott's STARLIMS® software-based Read more >> Riverain Technologies’ Temporal Comparison X-ray Software Receives FDA ClearanceUnique Technology Helps Identify Potential Lung Cancer Earlier DAYTON, Ohio--(BUSINESS WIRE)-- Riverain Technologies announced today that it has received 510(k) clearance from the Food and Drug Read more >> goBalto Completes a Successful FDA 21 CFR Part 11 Compliance AuditSAN FRANCISCO, Jan. 11, 2012 /PRNewswire/ -- goBalto, developer of new generation web-based clinical research solutions, announced that it successfully completed a FDA 21 CFR Part 11 compliance audit Read more >> Summit Seeks to Inform Electrophysiologists on Riata ICD RecallTwo major healthcare providers align to develop a consensus on recent Class I implantable cardioverter-defibrillator (ICD) recall MINNEAPOLIS--(BUSINESS WIRE)-- Cardiovascular leaders will gather in Read more >> FDA Clears Vioguard™ Self-Sanitizing Keyboard for Use in U.S. Hospitals and Medical ClinicsFirst FDA cleared computer keyboard to use germicidal properties of ultraviolet light to destroy harmful viruses and bacteria SEATTLE--(BUSINESS WIRE)-- Vioguard™LLC (www.vioguard.com) today Read more >> |
