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The company said its Biocell saline- and silicone-filled breast implants and tissue expanders will no longer be available in any market they’re currently cleared for, and healthcare providers should no longer use them. Read More
The company’s executive vice president, David Bailey, said the device is “innovative as it allows physicians to adequately address the issue when first detected/present.” Read More
Argentum has received FDA clearances for multiple indications for its wound dressing since 2003, and the U.S. military has used the product for treating blast and burn wounds. Read More
The company said its panel covers 50 diagnostic targets with 30 assays and delivers microorganism and resistance marker results in approximately five hours. Read More
“If approved, this labeling could broaden patient access by allowing for Medicare coverage of the world’s first and still the only commercially available hybrid closed loop system,” the company said. Read More
Today’s imaging for severe spinal deformities is primarily used for diagnostic purposes only,” said Mike Cordonnier, cofounder and CEO of Carlsmed. “The proprietary platform we are developing enables surgeons to use this information directly for surgical intervention. Read More
The guidance includes an updated manufacturer incident report (MIR) form that will be required for devices certified under MDD in January 2020. Read More
The devicemaker said it plans to launch the trial immediately in multiple U.S. centers that are experienced in cervical total disc replacement (TDR) procedures. Read More