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Changing a 510(k)-cleared device labeled for prescription use only to a device labeled for OTC use would likely require a new premarket submission, the FDA said. Read More
The Triton technology “will help improve the industry standards for quantifying blood loss in the labor and delivery department,” said Dylan Crotty, president of Stryker's instruments division. Read More
The company is developing permanently implanted stimulation electrodes for patients with chronic conditions, such as epilepsy, Parkinson's disease and chronic back pain. Read More
In combination with medical alert systems that respond to emergencies, “technology and ease of use for customers are key to the future of the connected health industry," said Andy Droney, senior director of health and innovation programs at the home security company ADT. Read More
The neurostimulation device increases tissue oxygenation by 28 percent and decreases pressure-induced tissue damage by 80 percent, the company said. Read More