FDAnews Device Daily Bulletin

Rep. Darrell Issa (R-Calif.) is expanding a congressional probe into reports the FDA monitored personal emails of employees who voiced device safety concerns to Congress, adding to GOP concerns that the agency used the information it gleaned to retaliate against nine CDRH staffers.

The FDA has issued a warning letter to Johnson & Johnson subsidiary Animas for repeated failure to report adverse events with its insulin pumps.

The Helping Hand Company issued an alert for its Turntable MK 6 model of the Skyframe hoist system after reports of patients falling from the system.

In a conference call with analysts Tuesday morning to discuss Medtronic’s quarterly earnings, Goldman Sachs analyst David Roman asked for details about the impact of the medical device tax given that Medtronic would be the first company including its effect in its financial guidance for fiscal 2013, which ends at the end of April next year.

The device center is dropping seven controversial 510(k) reform-related proposals, including creating a “class IIb” category of devices, following pushback from industry.

Edwards Lifesciences wasted no time in touting its success in bringing the first catheter-based aortic valve replacement system to the U.S. when the FDA cleared the Sapien TAVI system late last year, but the company has since taken a more patient approach to penetrating the market.

Someday, your doctor may turn to you and say, “Take two surgeons and call me in the morning.”

Device company NinePoint Medical said it has started a clinical trial of its optical imaging system after receiving 510(k) clearance from the U.S. Food and Drug Administration last month.

Aerotel Medical Systems received the U.S. Federal Communications Commission (FCC) Certification as well as Industry Canada (IC) certification for its innovative location-based personal alert system, GeoSkeeper.