Stryker receives FDA clearance for Sonopet 3 tissue removal platform
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Stryker (NYSE: SYK) announced it has received 510(k) clearance from the U.S. Food and Drug Administration for Sonopet 3, its latest ultrasonic bone and soft tissue removal platform.
The Portage, Mich.-based company said Sonopet 3 was developed with input from hundreds of surgeons and is designed to operate as a single platform for tissue removal in neurosurgical settings.
Mitch Foley, vice president and general manager of Stryker's Neurosurgical business, said in a statement: "Every major advancement in Sonopet 3 can be attributed to surgeon feedback, and together we're elevating the standard in neurosurgery. They told us they wanted more power, improved ergonomics and enhanced integration, helping them perform with confidence in demanding surgical environments."
The platform includes two technologies: RISE, described as a Reimagined Integrated Surgical Experience for connected surgical workflow, and Pulse Control, which is intended to help regulate the resection of hard and soft tissues.
According to a press release, the first clinical cases using Sonopet 3 are expected to begin in October, with a full commercial launch anticipated later in the fall.
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