May 24, 2013
| Vol.
10 No.
103
In observance of the Memorial Day holiday, FDAnews Device Daily Bulletin will not be published Monday, May 27. The next issue will be published Tuesday, May 28.
Healthcare providers experience the most frequent battery problems with large-volume infusion pumps and would like manufacturers to add green, yellow and red LED lights that change color when the battery status changes.
Strong buy-in at the top is essential to developing and maintaining a successful compliance program, experts told attendees at the Medical Device Manufacturers Association meeting last month.
Doctors in Youngstown, Ohio used a 3D printer to create a stent that saved the life of a baby with a pulmonary obstruction.
Researchers from Parion Sciences observed that the salt water spray inhaled while surfing seemed to help clear the lungs of cystic fibrosis patients, so they enlisted the help of Cambridge Consultants to create a nebulizer that aerosolizes salt water.
The FDA has sent an “It Has Come to Our Attention” letter to Biosense Technologies, claiming that it must reapply to market its uChek Urine Analyzer app since the app, which uses testing strips made by Bayer and Siemens, was not indicated in those companies’ marketing applications.
Senator Claire McCaskill (D-Mo.) is taking medical products supply companies to task for misleading senior citizens into ordering medical products that either they don’t need or that don’t come directly from their doctors.
Michael Hiltzik of the LA Times says that the campaign to repeal the medical device tax is a dishonest and narrow-minded means of impeding the success of the Affordable Care Act.
A clinic in Colorado is one of very few locations in the U.S. to possess a new medical device called EmbryoScope that might help many more women successfully conceive via in vitro fertilization.