FDAnews Device Daily Bulletin
Aug. 3, 2012 | Vol. 9 No. 152
Color-coding or labeling tubes to reduce risks associated with enteral tube misconnections will no longer be considered enough of a precaution under a new FDA draft guidance.
Revising the role and transparency of notified bodies in the EU’s medical device approval process could be the centerpiece of the European Commission’s September recast of the Medical Device Directive (MDD).
Medical devices such as blood pressure monitors and hearing aids brought in under the Special Authorisation Routes (SAR) will now cost less.
ELITech Molecular Diagnostics announced it received FDA clearance for its methicillin-resistant Staphylococcus aureus/Staphylococcus aureus ELITe MGB test.
DJO Global is hoping its OA Nano knee brace can help patients get a leg up on knee replacement surgery.
Covidien announced the official opening of its China Technology Center (CTC) Research and Development (R&D) facility in Shanghai.
Commercial-stage medical device maker Reflectance Medical has received U.S. Food and Drug Administration clearance for its CareGuide sensor.
Medical device maker Hologic said Wednesday that it completed its $3.8 billion acquisition of diagnostic test maker Gen-Probe.
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