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Last updated on April 16, 2014 at 17:34 EDT

Latest Center for Devices and Radiological Health Stories

2013-09-30 23:20:08

Smartphone technology opens a new world for medical device innovation. It also opens a can of worms with the FDA. Falls Church, VA (PRWEB) September 30, 2013 A smartphone app that can analyze urine is a really smart app. Indeed, it isn’t an app at all: It’s a medical device. Or is it? That’s the question troubling devicemakers everywhere, now that the FDA has made an example of Biosense. Biosense markets an app called uCheck that checks urine levels of blood, protein and other...

2013-09-23 23:02:42

Healthcare regulators, innovators, researchers, regulatory professionals and stakeholders from around the world will converge in Boston for the largest annual gathering for the healthcare product regulatory profession. Rockville, MD, USA (PRWEB) September 23, 2013 Healthcare regulators, innovators, researchers, executives from pharmaceutical, biotechnology and medical device companies, and other regulatory professionals and stakeholders from around the world will gather at the Hynes...

2013-09-19 20:21:31

App or Medical Device? FDA Regulation in the Smartphone Era FALLS CHURCH, Va., Sept. 19, 2013 /PRNewswire-iReach/ -- Medical Device Mobile Apps The Biosense Case: FDA Sends First Warning **FDAnews Virtual Conference** Oct. 3, 2013 -- 10:00 a.m. - 4:00 p.m. EDT www.fdanews.com/MDMobileAppsVC (Photo: http://photos.prnewswire.com/prnh/20130919/MN82966) Smartphone technology opens a new world for medical device innovation. It also opens a can of worms with the FDA. Could you get in trouble? A...

2013-09-18 08:28:49

FALLS CHURCH, Va., Sept. 18, 2013 /PRNewswire-iReach/ -- Eighth Annual FDA Inspections Summit New Powers, New Enforcement Posture, New Challenges **Presented by FDAnews** Oct. 23-25, 2013 - Bethesda, MD www.fdanews.com/FDAInspectionsSummitPR (Photo: http://photos.prnewswire.com/prnh/20130918/MN81242) For the first time, FDA officials can detain drug products they believe are adulterated or misbranded. They can detain the drug for up to 20 days, and a drug importer has just 5 days to appeal...

2013-09-04 16:26:28

FALLS CHURCH, Va., Sept. 4, 2013 /PRNewswire-iReach/ -- FDA Import Holds New Powers to Control Products **FDAnews Virtual Conference** Sept. 24, 2013 -- 10:00 a.m. - 4:00 p.m. EDT www.fdanews.com/FDAImportHoldsVC (Photo: http://photos.prnewswire.com/prnh/20130904/MN73975) The FDA has a new weapon in its arsenal -- the ability to detain for up to 20 days drug products it believes are adulterated or misbranded, in addition to its existing import hold powers. And, it's working closer than ever...

2013-09-03 12:26:18

System Designed to Improve Clinical Quality and Business Performance of Root Canal Therapy LAGUNA HILLS, Calif., Sept. 3, 2013 /PRNewswire/ -- Sonendo(®), the developer of a revolutionary technology for the endodontic marketplace, announced today that the company has received 510(k) FDA clearance for the first generation of its Multisonic Ultracleaning System(TM) set to launch in 2014. The device is designed to be a minimally invasive, disruptive technology that uses multiple...

2013-08-23 16:23:26

FALLS CHURCH, Va., Aug. 23, 2013 /PRNewswire-iReach/ -- Eighth Annual FDA Inspections Summit New Powers, New Enforcement Posture, New Challenges **Presented by FDAnews** Oct. 23-25, 2013 - Bethesda, MD www.fdanews.com/FDAInspections (Photo: http://photos.prnewswire.com/prnh/20130823/MN68857) For the first time, FDA officials can detain drug products they believe are adulterated or misbranded. They can detain the drug for up to 20 days, and a drug importer has just 5 days to appeal the...

2013-07-16 23:26:19

Revolutionary Science, the manufacturer of the FDA approved Saniclave 200, weighs In on the dangers of using a non-FDA approved autoclave for human use. Minneapolis, MN (PRWEB) July 16, 2013 Dental offices, medical clinics and even tattoo and nail salons are being required to use FDA cleared (approved) steam autoclaves, like the Tuttnauer Elara or the Saniclave 200 (retailing currently at about $999). Steam autoclaves such as these are highly regulated and have long been proven to be the...

Medical Devices Could Face Cyber Threats, Warns FDA
2013-06-14 12:03:29

Michael Harper for redOrbit.com — Your Universe Online The conversation of cyber security has largely focused on the issue of protecting national security and the private sector. Without proper preventive measures in place, hackers, spies and terrorists could inflict great harm upon our businesses and critical infrastructures. Now the FDA is trying to bring medical device makers into the conversation, asking them to upgrade their devices and systems to prevent dangerous attacks...

2013-06-10 08:31:18

FREDERICK, Md., June 10, 2013 /PRNewswire/ -- BioElectronics Corporation (OTC Pink: BIEL), the maker of advanced consumer medical devices, which has sold 500,000 devices, without prescriptions, in 57 countries reported that they have received three letters from the Office of Science Integrity. These letters are virtually identical in denying the firm's request for the FDA Commissioner to review her staffs' prior decisions. Dr. Jesse Goodman, Chief Scientist, said, "I have determined, in my...