FDAnews Device Daily Bulletin

Aug. 3, 2012 | Vol. 9 No. 152

FDA Draft Guidance Would Tighten Enteral Tube Connector Safety Rules

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risks associated with enteral tube misconnections will no longer be considered enough of a precaution under a new FDA draft guidance.

Shakeup of EU’s Notified Bodies System Key to MDD Recast

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).

HSA Lowers Fees for Imported Medical Devices

Medical devices such as blood pressure monitors and hearing aids brought in under the Special Authorisation Routes (SAR) will now cost less.

ELITech Receives FDA Clearance for MRSA/SA Test

ELITech Molecular Diagnostics announced it received FDA clearance for its methicillin-resistant Staphylococcus aureus/Staphylococcus aureus ELITe MGB test.

Knees: Could a Better Knee Brace Prevent Replacement Surgery?

DJO Global is hoping its OA Nano knee brace can help patients get a leg up on knee replacement surgery.

Covidien Opens $45 Million R&D Facility in China

Covidien announced the official opening of its China Technology Center (CTC) Research and Development (R&D) facility in Shanghai.

FDA Approves Reflectance Muscle Oxygen Monitor

Commercial-stage medical device maker Reflectance Medical has received U.S. Food and Drug Administration clearance for its CareGuide sensor.

Hologic Closes $3.8 Billion Deal for Gen-Probe

Medical device maker Hologic said Wednesday that it completed its $3.8 billion acquisition of diagnostic test maker Gen-Probe.

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