Medical Tubing and Extrusion

Medical tubing and extrusion technologies

surmodics

Surmodics announces regulatory delay for its SurVeil balloon
The FDA said it needed more information on biocompatibility and labeling.

By

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 … [Read more...] about Surmodics announces regulatory delay for its SurVeil balloon

Surmodics beats The Street in Q4 results, grows sales 8%

By

Surmodics (Nasdaq:SRDX) today posted fourth-quarter results that beat the overall consensus on Wall Street. The Eden Prairie, Minnesota-based IVD tech developer reported net losses of $14.7 million, or -$1.06 per share, on sales of $25.99 million for the three months ended Sept. 30, representing a sales growth of 8.41% compared to Q4 2021. The … [Read more...] about Surmodics beats The Street in Q4 results, grows sales 8%

Surmodics acquires Vetex Medical and its mechanical thrombectomy catheter

By

Surmodics (NSDQ:SRDX) announced that it acquired Vetex Medical, a developer and manufacturer of venous clot removal solutions. Buying Galway, Ireland–based Vetex Medical provides Surmodics a second FDA-cleared device for its thrombectomy portfolio. Vetex designed the ReVene thrombectomy catheter to remove large, mixed-morphology blood clots … [Read more...] about Surmodics acquires Vetex Medical and its mechanical thrombectomy catheter

FDA clears Surmodics radial access PTA dilation catheter

By

Surmodics this week said it received FDA 501(k) clearance for its Sublime Radial Access 0.014 Rapid Exchange Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter. The access catheter enables below the knee access through a transradial approach by providing a working length of 250cm. Outer balloon diameters range from 2mm to 4mm with … [Read more...] about FDA clears Surmodics radial access PTA dilation catheter