Device designed to treat below-the-knee vessels from the radial arteries with industry’s longest (250 cm) working length 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, announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Sublime™ Radial Access […]
Tag: Surmodics
Surmodics Receives CE Mark for its SurVeil™ Drug Coated Balloon
Next generation device adds new technology to how physicians approach treatment of PAD 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 CE Mark Certification in the European Union for its SurVeil™ drug-coated balloon (DCB). “I am […]
Surmodics Reports Second Quarter Fiscal 2020 Results and Provides COVID-19 Pandemic Update
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 announced results for its fiscal 2020 second quarter ended March 31, 2020, and suspended its financial guidance for fiscal 2020. Summary of Second Quarter and Recent Highlights Revenue of $22.8 million, an […]
Surmodics Reports First Quarter Fiscal 2020 Results
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 announced results for its fiscal 2020 first quarter ended December 31, 2019. Summary of First Quarter and Recent Highlights Revenue of $22.6 million, an increase of 2% year-over-year GAAP EPS of $0.01, […]
Surmodics Names Nusrath Sultana, MD, as Vice President, Clinical Affairs
EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–Surmodics, Inc. (NASDAQ: SRDX), a leading provider of medical device and in vitro diagnostic technologies to the healthcare industry, announced today Nusrath Sultana, MD, has joined Surmodics as Vice President, Clinical Affairs, effective February 3, 2020. “We are fortunate to have someone of Nusrath’s caliber joining the Surmodics team,” said Gary Maharaj, […]
The Surmodics Sundance™ Sirolimus-Coated Balloon Catheter Earns FDA Breakthrough Device Status
Sundance™ Sirolimus-Coated Balloon will receive prioritization throughout the FDA submission and review process to provide patients and physicians timely access to medical devices 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 the United States Food and Drug Administration […]
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 care industry, today announced it has completed enrollment in TRANSCEND, its pivotal clinical trial for […]
Surmodics Reports Second Quarter Fiscal 2019 Results
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 announced results for its fiscal 2019 second quarter ended March 31, 2019, and updated its financial outlook for fiscal 2019. Summary of Second Quarter and Recent Highlights Revenue of $22.7 million, an […]
Surmodics Sublime™ Guide Sheath Receives FDA 510(k) Approval
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, announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Sublime™ guide sheath. The highly flexible, proprietary Xtreme® braid-reinforced Sublime sheath is designed to resist kinking and maximize strength while retaining […]
Surmodics Provides Update Regarding TRANSCEND Clinical Trial
EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–Surmodics, Inc. (NASDAQ: SRDX), a leading provider of medical device and in vitro diagnostic technologies to the healthcare industry, has resumed patient enrollment into its TRANSCEND clinical trial and is nearly 75 percent of the way to its goal of 446 randomized patients. Patient enrollment in TRANSCEND, the pivotal clinical trial for the […]