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Fdanewsdevicedailybulletin

Oct. 12, 2012

Vol. 9 No. 201

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DoJ Lawyer: Research May Be Next Frontier in Anti-Fraud Investigations

Anti-fraud investigators may soon be taking a closer look at device clinical trials in an attempt to ensure that the safety and performance of devices reaching the market are supported by sound data, a government lawyer says. Read More

Ophthalmic Company Gets Form 483 on Procedure, Validation Issues

American Optisurgical, an ophthalmic device company based in Lake Forest, Calif., received a 13-observation Form 483 after an inspection by Irvine, Calif., CDRH staff that stretched from Jan. 30 to Feb. 23. Read More

University of Rochester to Develop Medical Devices

The University of Rochester is combining its expertise in the health, engineering and business fields to create the new Center for Medical Technology Innovation. Read More

In Developing FDA-Mandated Unique Identifier Code for Medical Devices, Don’t Ignore Suppliers

Five years after first talking about a unique device identifier that medical device makers would need to put on most medical devices and packaging, the FDA is nearing the end of the comment period for its proposed rule. Read More

Respiratory Motion Device Wins FDA Approval

Waltham devicemaker Respiratory Motion said it has received U.S. Food and Drug Administration approval for its respiration monitor. Read More

TriVascular Receives FDA Approval for Abdominal Stent

TriVascular received premarket approval from the FDA for a stent system that treats abdominal aortic dissections. Read More

Chinese Medical Device Market Has Many Pitfalls

According to analysts at Millennium Research Group, success in the Chinese medical device market depends on balancing risks such as the complex tendering process used by hospitals and the rise of domestic competitors against the real opportunities of this growing market. Read More

Intuitive Surgical Sued Over Heart Stabilizer Patent

Intuitive Surgical’s da Vinci surgical robot infringes at least one claim of a patent owned by Alisanos, according to a lawsuit. Read More