Voler Systems helps Simpson Interventions develop its pioneering image-guided system for minimally-invasive coronary treatment.
SUNNYVALE, CALIFORNIA, UNITED STATES, June 3, 2024 /EINPresswire.com/ -- Voler Systems, a prominent Silicon Valley electronic design leader specializing in medical devices, wearables, and IoT devices, is proud to announce its collaborative role in Simpson Interventions' development of its Acolyte Image Guided Crossing and Re-Entry Catheter System, an innovative OCT (Optical Coherence Tomography)-guided interventional catheter system. The system is designed to help improve outcomes for patients with chronic total occlusion (CTO), a condition characterized by total blockage in the coronary arteries.
Voler Systems leveraged its extensive expertise in regulatory compliance, medical product development, and engineering to assist Simpson Interventions in navigating the challenges associated with developing a medical device. Voler's work on the project included:
• Consulting on navigating the medical device regulatory landscape to ensure compliance throughout the software development lifecycle.
• Crafting a tailored test plan, validation and verification protocols, and risk analysis processes for first-in-human trials.
• Prioritizing essential development and regulatory activities to maximize resources and product development timeframe.
"A cornerstone of our mission at Voler Systems is to empower healthcare innovators to transform visions into accessible, life-saving realities," said Voler's President and CEO, Miguel Adao. "This project highlights our expertise in guiding startups like Simpson Interventions through the intricate process of medical device development."
The Acolyte system was recently granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA). This designation is granted to certain medical devices and device-led combination products that more effectively treat life-threatening or irreversibly debilitating diseases or conditions. Simpson Interventions can engage with FDA experts during the premarket review phase for timely feedback and prioritized submission review.
About Voler Systems
With more than four decades of experience in custom product design and consulting, Voler Systems is a leading Silicon Valley firmware design, electronics, software, and sensor development company. The company has built a solid reputation for reliable and innovative designs that meet the needs of modern businesses. With expertise in circuits, automation, motion control, and medical devices, Voler Systems is a leading provider of the underlying technologies and electronic device design for medical, wearables, IoT, consumer, and more.
About Simpson Interventions
Simpson Interventions is a leading medical technology company committed to addressing unmet clinical needs in cardiovascular diseases through technological innovations in visual guidance, enhanced intelligence, and electromechanical automation for minimally invasive percutaneous intervention.
Bryan Torres, Media Department
Voler Systems
bryan.torres@volersystems.com
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