FDAnews Device Daily Bulletin

An FDA warning letter issued to Hospira’s infusion pump plant in Costa Rica may be emblematic of broader companywide manufacturing issues, analysts say.

Manufacturers of Class III and Class IV in vitro diagnostic (IVD) devices will submit similar clinical and scientific information for summary technical document (STED)-based and non-STED-based license applications and amendments in Canada, according to two draft guidance documents.

At this week’s iPhone 5 announcement, Apple confirmed something of an open secret among those companies that make health peripherals for iOS devices: The longstanding 30-pin connector dock has been swapped out for a new slimmer, redesigned connector dock that Apple calls Lightning.

Electronic medical image sharing business lifeIMAGE was visited by a FDA inspector who spent four days at its Newton facility.

Syneron Dental Lasers announced it has signed a distribution agreement with LH Medical GmbH, a veteran distributor of cutting edge medical, dental and aesthetic products in Germany.

Medical devicemaker Covidien said it would close a South Carolina facility where it manufactures vascular products, laying off about 595 full-time employees, as it looks to improve efficiency across its global operations.

Ann Arbor, Mich.-area start-up Tangent Medical Technologies received a key nod of approval from the Food and Drug Administration to start selling an alternative device to traditional intravenous (IV) drug delivery systems.

Surgeons at UC Davis Medical Center have successfully implanted a new telescope implant in the eye of a patient with end-stage age-related macular degeneration, the most advanced form of the disease and a leading cause of blindness in older Americans.