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The noninvasive system assesses the mechanical efficiency and electrical activity of the heart, acquiring signals through a hand-held, smartphone-connected device that sends data to a cloud for analysis. Read More
The knee replacement system is installed using a simplified delivery model that includes a pre-sterilized kit and a single reusable instrument tray. Read More
The test consists of a single-use test cartridge, a lower nasal swab and a reusable, battery-powered cartridge reader that delivers the results to the mobile app. Read More
The device fits on a wire approximately four to five times the diameter of a human hair that can be easily threaded inside a PICC catheter, the company said. Read More
The device is designed to provide the lowest pressure signal drift amongst fiber optic guidewires and allows for consistent, repeatable measurements, the company said. Read More
The system is used at the point-of-care to provide information that can inform medical decisions, allowing patients to be screened for the presence of inflammation caused by bacteria, viruses, parasitic infections and other treatable inflammatory diseases. Read More
The device was approved under the agency’s humanitarian device exemption process, meaning it is intended to treat a disease or condition that affects no more than 8,000 patients per year. Read More