Ultrasound Reporting Platform Gets FDA Approval

Feb. 26, 2026 — AS Software, a provider of specialty-focused ultrasound reporting solutions, has announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for Asera, the next-generation version of its ultrasound reporting platform.

Asera represents an evolution of AS Software, maintaining the same intended use and core clinical functionality while introducing a redesigned user experience, enhanced workflows, and a scalable, cloud-based architecture.

“Asera marks a defining step forward for AS Software and for the ultrasound community we serve,” said Poornima Gopalakrishnan, CEO of AS Software. “We built our reputation on delivering efficiency, standardization, and scalable workflows. With Asera, we are advancing that foundation into a next-generation platform that unifies workflows, elevates the clinician experience, and turns data into meaningful intelligence.

Purpose-built for ultrasound-driven specialties, Asera goes beyond streamlining reporting to help practices operate smarter, scale with confidence, and prepare for a more connected, insight-driven future. It unifies ultrasound reporting and diagnostic image review within a single, cohesive platform designed around real-world clinical workflows. As care grows more complex—particularly in maternal-fetal medicine—Asera reduces navigation friction with persistent access to relevant patient information, minimizing unnecessary clicks and keeping clinicians focused on patient care.

Grounded in decades of women’s health ultrasound expertise, Asera includes out-of-the-box templates aligned with industry standards, along with flexible configuration to support each practice’s protocols. It also offers purpose-built support for first-trimester anatomy and Placenta Accreta Spectrum (PAS) assessment—reflecting AS Software’s focus on high-acuity scenarios where structured reporting supports earlier detection, clearer documentation, and coordinated care.

“A key focus of Asera was advancing the platform for scalability without altering its intended use,” said Scott Mullins, CTO of AS Software. “By enhancing the architecture and user experience while preserving core functionality and building on features proven in high-acuity settings, we’ve delivered a cloud-based platform designed for scale, seamless interoperability, advanced analytics, and continuous innovation.”

Asera builds on the proven foundation of AS Online, expanding what works, enhancing what matters most, and shaping what’s next. By connecting data, context, and workflows in a unified system, Asera reflects AS Software’s intentional approach to advancing the platform—investing in meaningful innovation that best supports our customers, their clinicians, and the evolving needs of their businesses.

To learn more about Asera go to www.as-software.com/contact-us/