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- First O-T-C defibrillator
- The FDA has cleared the over-the-counter sale of Philips Medical Systems' HeartStart, the first device of its kind designed for lay users. The defibrillator shocks the heart to restore rhythm after cardiac arrest.
- Research articles 2004-09-27
- Manufacturers of portable defibrillators will go to court to determine patent rights. (Supplier News).(Cardiac Science sues Philips Medical Systems North America )(Brief Article)
- Manufacturers of portable defibrillators will go to court to determine patent rights, following a recent lawsuit filed almost immediately after FDA approval of the latest device. Cardiac Science, Irvine, Calif., on Feb. 12 sued Philips Medical Systems North America in U.S. District Court in...
- Research articles 2003-03-01
- Home is where the AED is
- A new defibrillator was recently FDA-approved specifically to help save people who suffer cardiac arrest at home. The HeartStart Home Defibrillator, manufactured by Philips Medical Systems, is designed to be fast to learn and easy to operate. "This is a potentially valuable approach to the prevention of death from...
- Research articles 2002-12-01
- Philips Medical Systems North America, Cleveland, a division of Royal Philips Electronics, received FDA 510k clearance to market the Intera I/T. (Supplier News).(Brief Article)
- Philips Medical Systems North America, Cleveland, a division of Royal Philips Electronics, received FDA 510k clearance to market the Intera I/T, a magnetic resonance imaging system for intervention and therapy. The device includes a scanner that is optimized for interventional procedures and has...
- Research articles 2002-05-01
- Philips Medical Systems
- Philips Medical Systems, Shelton, CT, Sept. 14 New England. The untitled letter, appearing with warning letters on FDA's Web site, noted the field test of a diagnostic x-ray system assembled by the firm that yielded an out-of-specification reading for the entrance exposure rate. FDA requested that Philips correct...
- Research articles 1999-10-11
Additional Resources
- Maker of home defibrillator applies to remove prescription
- A division of Royal Philips Electronics is seeking clearance from the U.S. Food and Drug Administration to remove prescription requirements for the HeartStart Home Defibrillator. Originally cleared by the FDA in November 2002, the Philips Medical Systems HeartStart Home Defibrillator is the first new-generation defibrillator specifically designed for use in...
- Research articles 2004-07-29
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