The workforce reduction trend has swept the economy recently, and unfortunately, the medtech space is not immune to layoffs. You’ve probably read about the ongoing layoffs sweeping the tech industry, media and more. For instance, Yahoo, Disney, Zoom and more all reported workforce reductions as companies across industries grapple with economic pressures. Think inflation, supply […]
Surmodics
Surmodics has positive early results from thrombectomy system
Surmodics (Nasdaq:SRDX) today announced the successful early clinical use of its Pounce LP thrombectomy system. Eden Prairie, Minnesota-based Surmodics designed the LP (low-profile) thrombectomy system for the non-surgical removal of thrombi and emboli from the peripheral arterial vasculature. It performs this removal in vessels between 3.5 mm and 6 mm in diameter. It introduced the […]
Surmodics has positive data on multiple drug-coated balloons
Surmodics (Nasdaq:SRDX) today announced positive study results for two of its drug-coated balloon (DCB) technologies. The company presented data supporting the SurVeil and Sundance DCBs at the 50th Annual VEITH Symposium in New York. In the TRANSCEND trial, Surmodics evaluated the safety and efficacy of SurVeil versus the Medtronic In.Pact Admiral DCB. The trial evaluated […]
Surmodics launches new medical device coating technology
Surmodics (Nasdaq:SRDX) announced today that it launched its most advanced hydrophilic medical device coating technology. Eden Prairie, Minnesota-based Surmodics designed the Preside coatings to complement its existing Serene hydrophilic coatings. Preside offers a unique, low-friction and low-particulate generation coating. It further enhances distal access for neurovascular applications and improves crossing for coronary lesions or chronic […]
FDA approves Surmodics SurVeil drug-coated balloon
Surmodics announced today that the FDA granted approval for its SurVeil drug-coated balloon (DCB). Eden Prairie, Minnesota–based Surmodics may now market and sell SurVeil in the U.S. for percutaneous transluminal angioplasty. Use follows appropriate vessel preparation or de novo or restenotic lesions in femoral and popliteal arteries. These arteries feature reference vessel diameters of between […]
FDA clears Pounce LP thrombectomy system from Surmodics
Surmodics (Nasdaq: SRDX) today announced that it received FDA 510(k) clearance for its Pounce low-profile (LP) thrombectomy system. News of the regulatory nod comes just one day after Needham analysts upgraded Surmodics stock from “Hold” to “Buy.” The analysts cited positive developments pointing toward the likely approval of Surmodics’ SurVeil platform sooner than previously thought. […]
Surmodics enrolls first patient in Pounce thrombectomy system registry study
Surmodics recently announced it enrolled the first patient in its Prowl registry study of its Pounce thrombectomy system. Prowl is an open-label, retrospective, multi-center, U.S. registry of the Surmodics Pounce system for the non-surgical removal of emboli and thrombi in the peripheral arterial vasculature. The registry aims to collect real-world efficacy and safety outcomes data […]
Surmodics targets FDA premarket approval for drug-coated balloon in Q4
Surmodics (Nasdaq:SRDX) announced today that it received formal feedback from the FDA related to its SurVeil drug-coated balloon (DCB). Eden Prairie, Minnesota-based Surmodics gave the FDA a proposed approach to submit an amended premarket approval application for SurVeil. In January, the FDA indicated that Surmodics’ SurVeil PMA application is not approvable. The FDA said it […]
Surmodics is laying off roughly 60 workers
Surmodics (Nasdaq: SRDX) announced a restructuring that includes cutting 13% of the workforce at the Eden Prairie, Minnesota-based IVD tech developer. In its most recent annual report, Surmodics listed a headcount of 447, which means the layoff could involve nearly 60 workers. The cost-reduction plan will save roughly $10 million to $11 million in cash […]
Surmodics announces regulatory delay for its SurVeil balloon
The FDA noted more information on biocompatibility and labeling is needed.
The FDA has indicated that Surmodics’ Surveil drug-coated balloon premarket approval application is not approvable. According to an FDA letter to the company, Surmodics’ Surveil was not approved due to certain information in the biocompatibility and labeling categories. The governing agency said more information needs to be added by an amendment to Surmodics’ PMA application to […]