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FDA Approves Optilume Urethral Drug Coated Balloon, a breakthrough treatment for urethral strictures

Urotronic, Inc., a Minnesota based medical device company, announced that the U.S. Food and Drug Administration (FDA) has approved the Optilume Urethral Drug Coated...

Biofrontera Inc. Announces Notice of Allowance for U.S. Method-of-Use Patent on PDT-lamp

a biopharmaceutical company specializing in the commercialization of dermatological products, announced that the United States Patent and Trademark Office (USPTO) has issued a Notice...

FDA Proposes Changes to Food Safety Modernization Act Rule to Enhance Safety of Agricultural Water Used on Produce

The U.S. Food and Drug Administration issued a proposed rule that aims to enhance the safety of produce. It proposes to require farms to...

FDA Grants Clearance for Groundbreaking Bone Measurement Device

The Bone Score™ assessment is a fundamentally new approach to measuring bone.Using groundbreaking technology, the assessment introduces established engineering principals to the field of...

Therapixel receives FDA clearance for use of its AI-based breast cancer screening software MammoScreen® on Digital Breast Tomosynthesis

Therapixel, a company leading the use of AI-based products for women's health, announces it has received a second 510(k) clearance from the U.S. Food...
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