Tag: Surmodics

Surmodics Receives FDA 510(k) Clearance for Pounce™ XL Thrombectomy System, Expanding the Pounce Thrombectomy Platform to Larger Peripheral Arteries up to 10 mm in Diameter

EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–Surmodics, Inc. (Nasdaq: SRDX), a leading provider of medical device and in vitro diagnostic technologies, today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Pounce™ XL Thrombectomy System. “Securing FDA clearance […]

Surmodics Announces Launch of Preside™ Medical Device Coating Technology, Providing Industry-Leading Lubricity and Durability to a Broader Range of Complex Device Applications

EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–Surmodics, Inc. (NASDAQ: SRDX), the global leader in medical device coating technologies, announced the commercial launch of its most advanced hydrophilic medical device coating technology, Preside™ hydrophilic coatings. Preside hydrophilic coatings complement Surmodics’ existing Serene hydrophilic coatings by providing customers with a unique low-friction and low-particulate generation coating to further enhance distal access for neurovascular applications

MCRA Aids Surmodics in Obtaining FDA Pre-Market Approval for Cardiovascular Drug-Coated Balloon

WASHINGTON, Aug. 7, 2023 /PRNewswire/ — MCRA, LLC, a leading medical device focused regulatory advisory firm and clinical research organization (CRO) integrating U.S. and International Regulatory Affairs, Clinical Trial Operations, Reimbursement and Market Access, Healthcare Compliance, Cybersecurity, Quality Assurance, and Japan Distribution […]