Copyright © 2015 - 2022 Lifecarenews.in
LIFE CARE IS REGISTERED MAGAZINE IN RNI, NO.GUJGUJ/2015/71283
ROCHESTER, N.Y., Feb. 21, 2023 (GLOBE NEWSWIRE) — Casana, the leader in smart toilet heart health monitoring, today announced the appointment of medical device and regulatory veteran, Samir Zahine, as Chief Technology Officer. Zahine brings more than two decades of experience in medical device and software development within the healthcare space to propel Casana into its next phase of growth.
Prior to Casana, Zahine served as Vice President of Software and Informatics at Cantata Bio, assisting in the launch of the metagenomic NGS product, Galileo-ONE. Zahine also served as the Director of Software Engineering for both Abbott and Medtronic, overseeing the expansion of surgical and heart failure divisions.
“Sam is a fantastic addition to Casana’s executive team,” says Kara Johnson, VP of Regulatory Affairs and Quality Assurance at Casana. “His depth of knowledge specifically in Software Development Lifecycle practices, ISO 62304, Cybersecurity, and software architecture for Class B Medical Devices will pave the way for faster regulatory clearances and future device improvements.”
According to the FDA’s Center for Devices and Radiological Health (CDRH), more than 22,000 premarket submissions (including supplements and amendments) are submitted annually, as well as more than 1.4 million reports on medical device adverse events and malfunctions.
“The regulatory expertise Sam brings enables Casana to expeditiously pursue clearance by ingraining compliance standards into our daily procedures, circumventing prevalent submission hazards,” says Olivia Lew, Chief Operating Officer at Casana. “His appointment follows a series of strategic new hires and promotions over the last year, as Casana positions itself to launch our product in the home health monitoring market.”
Casana is seeking 510k clearance from the FDA in hopes of an initial product launch by the end of 2023. According to Zahine, continued development of Casana’s flagship product, the Heart Seat™, is expected to extend beyond the initial FDA clearance with additional clinical features. Continued expansion for Casana will align with key milestones achieved in advance of FDA clearance, such as building out go-to-market and operations teams to enable distribution of the Heart Seat, as well as focused hiring growth on research initiatives. To learn more about our open studies visit https://casanacare.com/research/.
Casana is changing the way healthcare does business with a smart toilet seat that enables effortless, integrated, and consistent in-home health monitoring. The Heart Seat™ captures key clinical measurements, including heart rate, blood pressure, and blood oxygenation, to assist medical teams with monitoring chronic conditions beyond the four walls of the hospital. The healthcare system has been searching for this actionable intelligence for decades, and it turns out, we were sitting on a great idea all along.
For more information about Casana, please visit www.casanacare.com and follow us on our social media channels: Facebook, Instagram, LinkedIn, and Twitter. Casana is actively hiring: casanacare.com/about/#careers
Director of Marketing & Communications