Why Acertara Invested in MAUI Imaging — and What It Means for Hospitals
Acertara leads MAUI Imaging’s U.S. pre-orders and distribution (outside MAUI direct sites) for FDA-cleared K3900; explore access, training, and QA support… Continue reading
Press Releases
Remanufacturing of Medical Devices Guidance for Industry, Entities That Perform Servicing or Remanufacturing, and Food and Drug Administration Staff Document issued on May 10, 2024.
Summary for Acertara customers The FDA guidance issued last week is a fresh and clarifying look at how to distinguish between repair and remanufacturing. The guidance document seeks to help companies engaged in these activities to understand how to interpret the existing laws that govern repair and remanufacturing. One key takeaway for Acertara customers is … Continue reading
Acertara Partners With Vanderbilt University and NINDS To Develop Revolutionary Ultrasound Technology for Nonaddictive Pain Relief
For Immediate Release Acertara Contact: Dave Dallaire sales@acertaralabs.com 303.834.8413 LONGMONT, CO, January 19, 2024 – In a major advance toward nonaddictive pain management, Acertara Acoustic Laboratories proudly announces its collaboration with Vanderbilt University Institute of Imaging Sciences and the National Institute of Neurological Disorders and Stroke (NINDS). This partnership is poised to develop a focused … Continue reading
Acertara Acoustic Laboratories Receives FDA Accreditation for the Agency’s Pivotal Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program
Acertara Acoustic Laboratories Receives FDA Accreditation for the Agency’s Piviotal Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program LONGMONT, Colorado– Acertara Acoustic Laboratories, an independent ISO/IEC 17025:2017 accredited medical ultrasound acoustic measurement, testing, and calibration laboratory, and ISO13485:2016 certified probe repair and new product development facility, announces that the United States Food and Drug Administration … Continue reading
Acertara Announces Its TEE Repair Processes Validated by CS Medical
LONGMONT, Colorado– Acertara Acoustic Laboratories, an independent ISO/IEC 17025:2017 accredited medical ultrasound acoustic measurement, testing, and calibration laboratory, and ISO13485:2016 certified probe repair and new product development facility, announces that its TEE probe repair processes have been validated by automated TEE reprocessor, CS Medical’s laboratory and engineering team. This testing process included more than 1,000 … Continue reading
Usono, Acertara Acoustic Labs announce Joint Sales Agreement for North America
EINDHOVEN, The Netherlands, LONGMONT, Colorado – Netherlands-based Usono has signed an exclusive deal with U.S.-based ultrasound specialist Acertara, to host its unique products for ultrasound probe fixation on Acertara’s dynamic e-commerce platform Tech For Health. Usono’s portfolio products – ProbeFix, ProbeFix Dynamic and ProbeFix Dynamic T – provide hands-off, lengthy, and stable attachment of an … Continue reading
Acertara Partners with CS Medical for TEE Probe Care
LONGMONT, CO February 9th, 2021. Acertara Acoustic Laboratories, the world’s only accredited independent diagnostic ultrasound testing laboratory and recognized leader in ultrasound probe repair, announces that they have partnered with CS Medical, the leading developer and manufacturer of automated cleaning and high-level disinfection devices for TEE probes, to provide a comprehensive probe care compliance solution … Continue reading
Acertara CEO Earns AIUM Fellowship
LONGMONT, CO December 7, 2020 Acertara Acoustic Laboratories, an ISO17025:2017 accredited and ISO13485:2003 certified ultrasound facility announces that its CEO, Wayne Moore, MBA, FASE has recently been elected by the American Institute of Ultrasound in Medicine (AIUM) as a Fellow. Fewer than 3 percent of AIUM members – a multidisciplinary profession association of approximately 9,000 … Continue reading
Acertara Celebrates the 20th Anniversary of its Acoustic Testing Laboratory
Longmont, CO October 12, 2020. Acertara proudly announces the twentieth anniversary of its ISO/IEC 17025:2017 accredited ultrasound acoustic testing laboratory. Working with ultrasound original equipment manufacturers (OEMs) and regulatory agencies around the world, our accredited ultrasound testing services provide OEMs with the quantitative IEC 60601-2-37 acoustic data required to obtain FDA 510(k) clearance to market … Continue reading
Acertara Makes Leap on Inc. 5000 Fastest Growing Company List
LONGMONT, CO August 14, 2019. Acertara Acoustic Laboratories, an ISO/IEC 17025:2017 accredited testing laboratory and ISO 13485:2016 certified ultrasound probe repair company, jumped up over 900 spots on Inc Magazine’s 39th annual Inc. 5000 list, the most prestigious ranking of the nation’s fastest-growing private companies. “Everyone at Acertara is committed to working with our health … Continue reading
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