May 20, 2013 | Vol. 10 No. 99
Makers of ultraviolet sunlamps used in tanning beds would have 15 months to submit 510(k)s demonstrating safety, if an FDA proposed rule takes effect.
Manufacturers transitioning hip, knee or shoulder joint replacement implants to Class III will not have to pay the US $1,190 annual application fee until July 1 2014, if the application is approved before June 30, 2013 and the Class IIb listing on the Australian Register of Therapeutic Goods is removed.
Researchers at MIT are developing nanoparticles that can monitor diabetic patients’ glucose levels – which may someday eliminate the need for diabetics to continually test their blood glucose.
A study of medical device spending in 66 countries found that it may actually be lower than most people thought.
The Food and Drug Administration in India’s Haryana state has sealed a factory that was selling unauthorized heart kits to hospitals in Delhi.
The CEO of Numera, a medical devicemaker, claims that emergency response medical devices that connect to Bluetooth are likely to become more and more popular among a younger, tech-savvier crowd.
Maquet Cardiovascular has been hit with a Class I recall of the batteries used to power transport ventilators.
Boston Scientific is set to present several of its medical devices at the company’s booth at Digestive Disease Week in Orlando May 18-21.
ePublishing :: CMS, Hosting & Web Development | © Copyright by FDAnewsAll rights reserved. Do not duplicate or redistribute in any form.