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Acertara Acoustic Laboratories

Acertara Acoustic Laboratories

Longmont, United States· Est.
acertaralabs.com
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Private Company

Funding information not available

Overview

Acertara Acoustic Laboratories, founded in 1998, is a U.S.-based leader in ultrasound probe repair, acoustic power measurement, and regulatory consulting for medical device companies. It operates an ISO/IEC 17025:2017 accredited test lab and an ISO 13485:2016 certified quality management system, serving hospitals, imaging centers, and OEMs. The company leverages deep technical expertise to offer a full suite of services including contract engineering, low-volume manufacturing, and 510(k) submission support, positioning itself as a vital partner in the ultrasound value chain.

DiagnosticsMedical Devices

Technology Platform

Patented ultrasound probe testing devices and an ISO/IEC 17025:2017 accredited laboratory for FDA/IEC-compliant acoustic power measurement and materials analysis.

Opportunities

Growth is driven by the expanding global ultrasound market, cost pressures in healthcare favoring repair over replacement, and increasing regulatory complexity for new device approvals.
The company is well-positioned to serve both legacy system sustainment and innovative startup ecosystems.

Risk Factors

Risks include dependency on OEM certifications and large client contracts, potential technological shifts away from repairable probe designs, and changes in regulatory standards that could necessitate significant reinvestment in testing capabilities.

Competitive Landscape

Acertara competes in the ultrasound probe repair and testing market against OEM in-house service divisions, third-party independent service organizations (ISOs), and other specialized acoustic labs. Its key competitive advantages are its ISO 17025 accreditation for regulatory testing, patented measurement technology, and high repair success rate for complex probes.

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