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 […]
Tag: SurVeil
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 […]
Surmodics Provides Regulatory Update Related to its FDA Premarket Approval Application for the SurVeil™ Drug-Coated Balloon
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 it has received a letter from the U.S. Food and Drug Administration (FDA; the Agency) related […]
12-Month Data from Surmodics’ TRANSCEND Trial Presented at LINC 2021 Event
SurVeil™ Drug Coated Balloon (DCB) demonstrates non-inferior safety and efficacy, while using a substantially lower drug dose, vs. the IN.PACT® Admiral® DCB for treatment of femoropopliteal lesions. EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–Surmodics, Inc. (NASDAQ:SRDX), a leading provider of medical device and in vitro […]
Surmodics Completes Enrollment in Pivotal TRANSCEND Clinical Trial
Study designed to evaluate safety, efficacy of the company’s next-generation SurVeil™ drug-coated balloon Company Raises 2019 Revenue and EPS Guidance EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–Surmodics, Inc. (NASDAQ:SRDX), a leading provider of medical device and in vitro diagnostic technologies to the health […]