Urotronic today announced that it received FDA approval for its Optilume urethral drug-coated balloon for male urethral strictures. Plymouth, Minnesota–based Urotronic designed the paclitaxel-coated balloon to inhibit new scar tissue growth that can occur after endoscopic dilations. Urethral strictures are scars in or around the urethra that can … [Read more...] about FDA approves Urotronic’s Optilume drug coated balloon for urethral strictures
Study: Stereotaxis robotic technology reduces silent cerebral embolism during AFib ablation
Stereotaxis announced the positive results from a study of its robotic magnetic navigation system in atrial fibrillation ablation. The multi-center, prospective study evaluated 166 patients with paroxysmal or persistent AFib who underwent pulmonary vein isolation using Stereotaxis' robotic magnetic navigation (RMN) technology or manual contact … [Read more...] about Study: Stereotaxis robotic technology reduces silent cerebral embolism during AFib ablation
Foldax gets greenlight in India for biopolymer surgical aortic heart valve clinical trial
Foldax this week announced that India's medical device regulatory body approved initiation of a clinical trial to study its Tria biopolymer surgical aortic heart valve. Salt Lake City-based Foldax designed the Tria heart valve to resist calcification, withstand stresses and strains without failure and restore patient quality of life without the … [Read more...] about Foldax gets greenlight in India for biopolymer surgical aortic heart valve clinical trial
Ambu awarded single-use endoscopy contract with Vizient
Ambu today announced that it has been awarded a contract for single-use visualization devices with Vizient, effective Feb. 1, 2022. The contract will help Ballerup, Denmark-based Ambu expand its single-use endoscope market by offering Vizient members pre-negotiated pricing and terms for Ambu's single-use products, which include bronchoscopy, … [Read more...] about Ambu awarded single-use endoscopy contract with Vizient
Ambu wins video laryngoscopy award with Vizient
Ambu today announced that it was awarded a contract for video laryngoscopes with Vizient. The contract covers Ballerup, Denmark-based Ambu's King Vision video laryngoscope system for quick and easy intubation with a display for a real-time view of a patient's airway. The contract also includes Ambu's next-generation video laryngoscope that is … [Read more...] about Ambu wins video laryngoscopy award with Vizient
FDA clears Avinger’s Pantheris for in-stent restenosis
Avinger this week announced that it received FDA 510(k) clearance for a new clinical indication for its Pantheris image-guided atherectomy system. The new indication allows the Redwood City, California–based company to market the device for in-stent restenosis (ISR) treatment in the lower extremity arteries. “We are excited to receive FDA … [Read more...] about FDA clears Avinger’s Pantheris for in-stent restenosis
Penumbra beats the Street in Q3, grows sales 25%
Penumbra (NYSE:PEN) posted third-quarter results this week that beat the overall consensus on Wall Street. The Alameda, California-based company reported profits of $8.85 million, or 24¢ per share, on sales of $190.1 million for the three months ended Sept. 30, for a sales growth of 25.84% compared with Q3 2020. Adjusted to exclude one-time … [Read more...] about Penumbra beats the Street in Q3, grows sales 25%
FDA clears XO Cross microcatheters
Transit Scientific this week announced that it has received FDA clearance for its hydrophilic-coated XO Cross microcatheters for guidewire support, exchange and contrast media injection in the peripheral vasculature. The 510(k) clearance includes new 2Fr XO Cross 14 microcatheters, 2.6Fr XO Cross 18 microcatheters and 3.8Fr XO Cross 35 support … [Read more...] about FDA clears XO Cross microcatheters
Argon Medical launches portal vein access devices
Argon Medical Devices today announced that it has launched two unique portal vein access sets for transjugular access in diagnostic and interventional procedures. Frisco, Texas-based Argon designed its Scorpion portal vein access series to address the challenge of placing a transjugular intrahepatic portosystemic shunt. The series includes the … [Read more...] about Argon Medical launches portal vein access devices
Medtronic issues warning for some perfusion tubing packs
Medtronic has issued a warning letter regarding some of its Perfusion Tubing Packs. Friedly, Minnesota-based Medtronic's urgent field safety notice informs users that some of its Perfusion Tubing Packs were manufactured without device-level testing for bacterial endotoxin, which is a necessary step to support non-pyrogenic label claim. The … [Read more...] about Medtronic issues warning for some perfusion tubing packs
