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Fdanewsdevicedailybulletin

July 23, 2012

Vol. 9 No. 143

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Australia Reclassifies Joint Implants as High-Risk Devices

Makers of hip, knee and shoulder joint implants have two years from July 1, 2012, to apply for their products to be transitioned from Class IIb to Class III devices in Australia, the Therapeutic Goods Administration (TGA) said. Read More

Global Imaging Industries Formalize Long-Standing Working Relationship

After 12 years, the Global Diagnostic Imaging, Healthcare IT & Radiation Therapy Trade Association (DITTA) has officially incorporated in the U.S., a move that will allow it to better influence discussions on global medical imaging concerns, an association official says. Read More

Medical-Device Security Isn’t Tracked Well, Research Shows

Medical devices often use commercial PCs and have wireless connections that make them vulnerable to malware, or require software updates for security, but the U.S. may not be doing an adequate job tracking these risks, researchers indicated in a study published Friday. Read More

Study Finds Biomedical Device Industry Faces Growing Talent, Development Gap

A new study has found that the biomedical device industry must change the way it does business in order to compete in today’s competitive global market. Read More

FDA Panel Scheduled to Review Second Sight’s Argus II Retinal Prosthesis System

Second Sight Medical Products announced that an FDA Ophthalmic Devices Advisory Panel has been scheduled to review the data presented in the company’s HDE market approval application for its Argus II Retinal Prosthesis System. Read More

A New Device for a Chronic Bladder Problem

The pain of interstitial cystitis can be as unrelenting as the urge to urinate. Read More

Lazarus Effect Funnel Guide Catheter Receives CE Mark

Lazarus Effect, a medical device company focused on improving treatment of acute ischemic stroke through effective removal of the blood clots that cause a stroke, announced today that the Lazarus Funnel Guide Catheter has received CE Mark. Read More

Stronger US Sales Bolster Baxter’s 2Q Profit

Baxter International said its net income rose 7 percent in the second quarter on one-time gains and better sales of a hemophilia drug, blood plasma products and dialysis devices. Read More