FDAnews Device Daily Bulletin
June 21, 2012
| Vol.
9 No.
122
A report of an exposed conductor in a St. Jude defibrillator lead has renewed questions about the safety of some of the company’s cardiac products.
A review of several corrective and preventive action (CAPA) forms at Aqueduct Medical’s San Francisco facility revealed inadequate CAPA validation and follow-up, a recent Form 483 states.
Medical devices are not uncommon. In fact, according to Consumer Reports tens of millions of Americans live with medical devices within their bodies.
Definition Edge is the first single-source CT scanner to use the vendor’s Stellar Detector, which integrates the detector’s miniaturized electronics with the photodiode, Siemens said.
Minnesota is home to more than 350 medical technology companies, directly employing more than 35,000 people — making the state a muscular world giant of the industry.
St. Jude Medical has received the Food and Drug Administration’s approval to launch its AMPLATZER Vascular Plug 4 device in the U.S.
Appian, the global innovator in enterprise and cloud-based business process management (BPM) software, announced that the Saudi Food and Drug Authority has expanded its use of the Appian BPM Suite.
CareFusion announced an agreement to make bi-directional connectivity available between CareFusion’s Alaris System and Epic’s electronic medical record platform.
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