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Home » Olympus sold ‘superbug’ scopes without FDA clearance | Regulatory news for the week of March 9, 2015

Olympus sold ‘superbug’ scopes without FDA clearance | Regulatory news for the week of March 9, 2015

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FDA: Olympus sold 'superbug' scopes without our clearance

March 5, 2015 by Brad Perriello

Olympus sold 'superbug' scopes without FDA approval

The FDA yesterday confirmed that Olympus sold the endoscopes implicated in a series of deadly hospital-acquired infections without the safety watchdog’s approval, as more hospitals in California and Connecticut reported infections from the scopes.

Although the fiberoptic Olympus TJF-Q180V duodenoscope “does not currently have a 510(k) clearance,” the FDA said, it’s not advising hospitals to cancel scheduled endoscopic retrograde cholangiopancreatography procedures using that device or 2 other models made by Fujifilm Holdings and Ricoh’s Pentax subsidiary. Read more

FDA clears 1 Hospira plant, flags another

March 3, 2015 by Mark Hollmer

FDA passes 1 Hospira plant, flags another

Hospira must deal with an FDA citation regarding a plant in India, even the federal safety watchdog lifted a warning on its infusion pump plant in Costa Rica.

Lake Forest, Ill.-based Hospira said in a recent regulatory filing that the FDA cited its pharmaceutical facility in Visakhapatnam, India, after an inspection last month. Hospira said it will respond to all of the as-yet-unnamed issues the FDA outlined in what is known as a Form 483, which regulators issue when they see potential violations. Read more

GI Dynamics plunges 50% after FDA halts trial

March 6, 2015 by Brad Perriello

GI Dynamics plunges 50% after FDA halts trial

GI Dynamics said late yesterday that the FDA halted enrollment in a clinical trial of its EndoBarrier weight loss device after a few patients developed liver infections, sending share prices plunging by 50%.

Lexington, Mass.-based GI Dynamics said the FDA stopped enrollment in its325-patient Endo trial after 4 patients developed bacterial infections known as hepatic abscesses. The trial will continue for the patients GI Dynamics has already enrolled, the company said. Read more

Sunshine Heart stops trial enrollment after patient deaths

March 6, 2015 by Brad Perriello

Sunshine Heart stops trial enrollment after patient deaths

Sunshine Heart shares plunged after the company said it’s halting enrollment in a clinical trial of its C-Pulse heart failure device after 4 patients died.

Eden Prairie, Minn.-based Sunshine Heart said the trial’s protocol requires it to stop enrolling subjects while it consults with the FDA if more than 3 of the trial’s 1st 20 patients die. Two of the 4 deaths have been determined to be unrelated to its device, the company said. Read more

Petition accuses Bayer's Conceptus of altering Essure trial data

March 9, 2015 by Brad Perriello

Petition accuses Bayer's Conceptus of altering Essure trial data

A citizens petition lodged with the FDA last month wants the safety watchdog to take healthcare giant Bayer’s Essure permanent female sterilization device off the market, alleged that the clinical data the FDA used to approve the device was fudged and that the company concealed adverse events associated with Essure.

“The PMA process for Essure was replete with fraud on the FDA including the altering of medical records of trial participants,” the Feb. 25 petition alleges. Read more

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