Advanced Medical Solutions Group (AMS) has received 510(k) approvals from the United States FDA for their Silver High Performance Dressing and Silicone PHMB Foam Dressing.
The company also announced that, following these approvals, both products will be commercialized via their pre-existing network of wound-care partner and distributors.
510(k) approvals, also known as Premarket Notifications, allow the FDA to determine whether the medical device in the application is “equivalent to a device already placed into one of the three classification categories.”
Such a designation, then, indicates to the market that AMS’s products are in fact a novel introduction into the adhesive dressing space.
AMS’s Silver High Performance Dressing features “next generation antimicrobial gelling fibre technology with excellent performance and patent protected construction” and can be used for chronic wounds such as ulcers and post-operative surgical wounds.
An atraumatic adhesive dressing, Silicone PHMB has given AMS leverage into the over $100 million US market, which continues to grow at 6% year-on-year, for atraumatic antimicrobial foam.
Chris Meredith, Chief Executive Officer of Advanced Medical Solutions, commented on the news:
"These two additional approvals significantly strengthen AMS's US advanced wound-care portfolio and support for the Group's wound-care partners and end users.
They also demonstrate the value generated by AMS's R&D and Regulatory capabilities which are a key pillar of our strategy to drive organic growth."
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