Saranas seeks FDA de novo classification for Early Bird bleed monitor

Internal bleeding detection device developer Saranas said today it submitted an FDA application seeking de novo classification for its Early Bird bleed monitoring system.
The Early bird device is designed as a standard vascular access sheath which is embedded with sensors which detect bleeding from accidentally ruptured blood vessels during cardiac procedures, including transcatheter aortic valve replacements, the Houston, Texas-based company said.
“This is an important milestone for Saranas as it illustrates the ability of our team to execute on our development and regulatory strategies. This submission, which incorporates recommendations provided by the FDA during pre-submission communications, is the culmination of the collective effort and success of our team in completing important biocompatibility, design verification testing, and preclinical animal studies. We look forward to continuing our preparation to bring this innovative technology to the market upon FDA clearance,” prez & CEO Zaffer Syed said in a prepared statement.
Saranas said that the technology behind its Early Bird system was developed at the Texas Heart Institute.
“The Early Bird Bleed Monitoring System is designed to protect, and in some cases, save the lives of patients undergoing an endovascular procedure by allowing physicians to detect the onset of bleeding early and take appropriate steps to address the bleed before detrimental, irreversible and life-threatening consequences ...

Source: Mass Device - April 24, 2018 Category: Medical Devices Authors: Fink Densford Tags: Blood Management Food & Drug Administration (FDA) Patient Monitoring Regulatory/Compliance saranas Source Type: news