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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
The FDA hopes that having greater confidence in laboratories’ test methods and results will mean more consistent and predictable assessments of conformance to standards. Read More
The enhancements “provide an appropriate level of flexibility to maximize symptom relief as patients settle into their everyday lives,” the company said. Read More
The product is made of a synthetic biomaterial derived from citrate, a naturally occurring antimicrobial and anti-inflammatory molecule that is involved in bone regeneration. Read More