FDAnews Device Daily Bulletin

Organizations that audit device establishments must ensure their findings document conformity, nonconformity or potential nonconformity with established best practices based on objective evidence, according to a draft standard released by the International Medical Device Regulators Forum (IMDRF).

Medical device companies looking to introduce high-risk devices in Singapore will have the option of expedited registration evaluation routes, according to a draft guideline from the Health Sciences Authority (HSA).

The writing on the wall was there before, but now it is shining unmistakably like reflective paint on a dark night.

Boston Scientific, the second-largest seller of drug-coated stents, agreed to buy Vessix Vascular for as much as $425 million to speed its entry into the market for hard-to-treat hypertension devices.

Our ears work by converting the vibrations of the eardrum into electrochemical signals that can be interpreted by the brain.

The Food and Drug Administration will allow Cerus to submit a premarket application toward approval of its blood safety system, the company said Wednesday.

Kips Bay Medical announced the FDA has granted approval with conditions of Kips Bay Medical’s IDE to include four U.S. study sites in the “eMESH I” clinical feasibility trial of its eSVS Mesh.

Stryker announced the appointment of David K. Floyd to the role of Group President, Orthopaedics, effective Nov. 15, 2012.