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Despite — or in part because of — COVID-19 challenges, the FDA’s Center for Devices and Radiological Health (CDRH) cleared a record 132 novel devices in 2020, surpassing its previous record of 106 in 2018. Read More
When the device’s hemostat powder makes contact with blood or fluid in the gastrointestinal tract, a gelled matrix forms to provide a barrier that helps to further control bleeding, the company said. Read More
The company said the system’s closed-loop stimulation feature, which automatically adjusts to patients’ individual needs, is currently in clinical evaluation. Read More
The diagnostic is designed for professional use as a point-of-care test in clinical and non-clinical settings, including healthcare centers, travel hubs, educational institutions and businesses, PerkinElmer said. Read More
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