Tag: Surmodics

Surmodics Reports Fourth Quarter and Fiscal Year 2023 Financial Results; Introduces Fiscal Year 2024 Financial Guidance

EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–Surmodics, Inc. (Nasdaq: SRDX), a leading provider of medical device and in vitro diagnostic technologies to the healthcare industry, today reported financial results for its fourth quarter and fiscal year ended September 30, 2023, and introduced its financial guidance for the fiscal year ending September 30, 2024. “We are pleased with our […]

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 Logistics (DMAH) is pleased to announce its role in the successful Premarket Approval (PMA) application decision […]

Surmodics Reports Third Quarter of Fiscal Year 2023 Financial Results; Updates Fiscal Year 2023 Financial Guidance

EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–Surmodics, Inc. (Nasdaq: SRDX), a leading provider of medical device and in vitro diagnostic technologies to the healthcare industry, today reported financial results for its third quarter ended June 30, 2023, and updated its financial guidance for its fiscal year ending September 30, 2023. “Our third quarter was marked by a combination […]

Surmodics Receives FDA Approval for the SurVeil™ Drug-Coated Balloon

Surmodics to receive $27 million milestone payment from Abbott EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–Surmodics, Inc. (NASDAQ:SRDX), a leading provider of medical device and in vitro diagnostic technologies to the health care industry, today announced the receipt of U.S. Food and Drug Administration (FDA) approval for the SurVeil™ drug-coated balloon (DCB). The SurVeil DCB may now be […]

Surmodics Receives FDA 510(k) Clearance for Pounce™ LP Thrombectomy System

Addition to Pounce™ thrombectomy platform with the low-profile (LP) model will allow for efficient clot removal in below-the-knee peripheral arteries (2 mm to 4 mm), expanding the addressable market for the Pounce™ platform EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–Surmodics, Inc. (Nasdaq: SRDX), a leading provider of medical device and in vitro diagnostic technologies, announced it has received […]

Surmodics Reports Second Quarter of Fiscal Year 2023 Financial Results; Updates Fiscal Year 2023 Financial Guidance

EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–Surmodics, Inc. (Nasdaq: SRDX), a leading provider of medical device and in vitro diagnostic technologies to the healthcare industry, today reported financial results for its second quarter ended March 31, 2023, and updated its financial guidance for its fiscal year ending September 30, 2023. Second Quarter Fiscal 2023 Financial Summary Total Revenue […]

Surmodics Announces First Patient Enrolled in PROWL Registry Study Using the Pounce™ Thrombectomy System

Registry to enroll up to 500 patients at up to 30 sites, collecting real-world outcomes data for the Pounce™ Thrombectomy System EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–Surmodics, Inc. (Nasdaq: SRDX), a leading provider of medical device and in vitro diagnostic technologies, today announced enrollment of the first patient in PROWL, the Pounce™ Thrombectomy System Retrospective Registry. PROWL […]

Surmodics Announces Successful First Patient Use of Sublime™ Radial Access Microcatheter Designed for the Periphery

Sublime Radial Access Platform to include the industry’s first suite of torqueable peripheral microcatheters, designed for navigating tortuosity and crossing complex lesions and available for both transradial and transfemoral procedures EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–Surmodics, Inc. (NASDAQ:SRDX), a leading provider of medical device and in vitro diagnostic technologies to the health care industry, today announced that […]

Surmodics Provides Regulatory Update on its Strategy to Submit an Amended Premarket Approval Application for the SurVeil™ Drug-Coated Balloon

Announces Receipt of Positive Formal FDA Feedback via the Q-Submission Program Substantially reduces the anticipated time and cost needed to receive a PMA EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–Surmodics, Inc. (NASDAQ:SRDX), a leading provider of medical device and in vitro diagnostic technologies to the health care industry, today announced that it has received formal feedback from the […]