FDA clears new version of Boston Scientific's SpyGlass
February 26, 2015 by Brad Perriello
Boston Scientific said the FDA granted 510(k) clearance for the latest iteration in its line of cholangioscopy and pancreatoscopy devices, the SpyGlass DS.
Marlborough, Mass.-based Boston Scientific said the endoscope is designed to provide images of the biliary system in endoscopic retrograde cholangiopancreatography procedures when X-ray imaging isn’t sufficient. Read more
Joint FDA panel recommends OK for Avedro's eye treatment
February 27, 2015 by Mark Hollmer
Avedro said a joint meeting of 2 FDA advisory panels considering its corneal cross-linking technology to treat 2 eye conditions this week voted to recommend approval.
The FDA’s Dermatologic & Ophthalmic Drugs Advisory Committee and its Ophthalmic Devices Panel Feb. 24 reviewed the data on Boston-based company’s KXL system, which uses riboflavin ophthalmic solutions with UVA irradiation to treat progressive keratoconus or corneal ectasia. Read more
Staar Surgical posts Q4, 2014 losses
February 26, 2015 by Brad Perriello
Shares in Staar Surgical opened down 5.1% today, but had clawed their way back to a more than 9% gain by the close of trading, after the implantable lens maker reported red ink for the 4th quarter and 2014 but came close to meeting Wall Street’s earnings expectations.
Monrovia, Calif.-based Staar’s Q4 losses gaped 189.7% to -$2.5 million, or -7¢ per share, on sales of $16.6 million for the 3 months ended Jan. 2, compared with Q4 2013. Adjusted to exclude 1-time items, per-share losses were -3¢, in line with The Street. Read more
FDA removes unregistered medical device establishments from database
March 2, 2015 by MassDevice
On Monday, February 16, 2015, the U.S. Food and Drug Administration (FDA) purged approximately 2,628 medical device establishments that did not complete their annual registrations by the deadline from its registration database. Owners and operators of companies that produce and distribute medical devices for use in the United States are required to register with FDA and review their listing information between October 1 and December 31 each year. On December 30, 2014, before the fiscal year 2015 registration deadline, there were approximately 24,123 device establishments in FDA’s database. On February 18, 2015, the number had been reduced to approximately 21,495.
Failure to register a device establishment with FDA is a prohibited act under the Food, Drug, and Cosmetic Act (FD&C Act). Devices shipped to the U.S. by an unregistered establishment may be denied entry. FDA may hold the devices at the port of entry until the establishment is properly registered. Read more
FDA panel to review brain aneurysm devices
March 2, 2015 by Mark Hollmer
An FDA advisory panel is slated to meet in April to discuss flow diversion technology – stent-like devices used to treat brain aneurysms – and evaluate how they’re designed and tested for human use.
The FDA’s Neurological Devices Panel is scheduled to meet April 17 to discuss the technology, also known as coil embolization devices, which work by diverting blood flow away from aneurysms, especially large or wide-necked aneurysms. Read more