standards
Artificial Pancreas Draft Guidance Issued
Dec 01, 2011
FDA today released draft guidance for artificial pancreas device systems for treatment of type 1 diabetes, an event one advocacy group is hailing as a “...
The Wait Is Over for IEC 80001
Nov 02, 2010
It's been a long wait, but IEC 80001 has just been approved. This is a standard governing risk management for networks incorporating medical devices. Read more...
AAMI Honors Medtech Contributors
Jul 21, 2010
AAMI awarded nine professionals in the device industry for their contributions to medical technology. See the list below: AAMI Foundation Laufman-...
FDA Meets to Debate Glucose Meters
Mar 17, 2010
At a two-day meeting (March 16-17) to review self monitoring blood glucose (SMBG) meters, FDA officials and staff  sought input from medical experts,...
CDRH Officially Recognizes IEC 60601-1
Mar 11, 2010
CDRH is immediately recognizing IEC 60601-1, third edition. The announcement was made yesterday morning at the 20th annual AAMI/FDA international standards...
Harmonizing China
Apr 28, 2009
The US-China Joint Commission on Commerce and Trade's (JCCT) Pharmaceuticals and Medical Devices subgroup recently met to discuss medical devices, reports...