SRS Medical Nabs Approval in South Korea
The Korean Food and Drug Administration has granted approval to SRS Medical Systems’ Spanner temporary prostatic stent. The device is intended to relieve lower urinary track symptoms in patients in temporary urinary retention, the company says. The Spanner has FDA approval for a single 30-day period in a limited population. In addition, the device has been approved in Saudi Arabia and received IDE approval from the FDA in January.
Physio-Control Recalls AED Electrodes
Physio-Control has announced a recall of specific lots of its Quik-Combo adult pacing/defibrillation/ECG electrodes and its Red-Pak preconnected system due to possible damage to the wire insulation during the manufacturing process. The company asks that customers quarantine and return any unused products, according to a safety notice. No complaints related to the issue have been received, the safety notice adds. However, using a damaged product could result in an increased risk for reduced or no patient therapy, arcing of current, sparking or patient or clinician burns.
bioLytical Develops Zika Test
bioLytical Laboratories has developed a preclinical prototype assay to detect Zika antibodies in patient samples collected shortly after the onset of symptoms. The prototype is developed on the company’s INSTI rapid test platform, which is capable of providing results in as little as 60 seconds. The preclinical test successfully detected Zika antibodies from infected patient serum or plasma with minimal cross-reactivity with confirmed positive Dengue or Chikungunya sera.
B. Braun, ICU Medical Enter Deal
ICU Medical has reached a long-term distribution agreement through which B. Braun will market ICU’s SwabCap disinfecting cap for needleless connectors. Under the agreement, B. Braun will gain distribution rights to promote SwabCap in more than 30 countries outside the U.S. SwabCap is disposable and intended to disinfect needleless connectors while improving the barrier to bacterial ingress and refining visual swabbing compliance, the company says. Financial terms of the deal were not disclosed.
Clarius Introduces Ultrasound Scanner
Clarius Mobile Health has unveiled the first mobile ultrasound scanner, with an application for iPhone and Android devices, at the American Institute of Ultrasound in Medicine Conference. Clarius is offering a number of scanners for the price of a traditional compact system, which ranges from $25,000 to $70,000, according to the company. The scanner is awaiting clearance from the FDA, as well as sign-offs in Europe and Canada.
Boston Scientific Introduces AXIOS System
Boston Scientific has launched its AXIOS stent and electrocautery enhanced delivery system, indicated to manage pancreatic pseudocysts and walled-off pancreatic necrosis. The lumen-apposing, expandable stent aids in the drainage of pancreatic fluid collections and reduces the risk of leakage and migration, the company says. AXIOS is the only removable metal stent in the U.S. intended for PFC drainage. The system lowers costs by minimizing procedural time, length of hospital stay and X-ray exposure.