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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

May 17, 2021 Press Releases

The Commoditization of Ultrasound: The Hand-held Avalanche

G. Wayne Moore05/09/2021 Diagnostic ultrasound systems have been through multiple technologically important inflection points over the last 40 years – including the first one I was directly involved in – the transition from analog to digital scan conversion. However, hand-held battery-operated ultrasound devices are not new. Indeed, a company called Organon Teknika introduced the pictured … Continue reading

May 17, 2021 Newsletter

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

May 3, 2021 Press Releases

Can Ultrasound Read Your Mind?

Mark V. Kingsley04/09/2021 Short answer: Yes, it can. Long Answer: In the 1980s, neuroscientist Benjamin Libet conducted a controversial study that found a half-second delay when measuring the time between when subjects felt they had made a conscious decision to flick their wrists and the corresponding neural activity in the brain. The neural activity in … Continue reading

April 8, 2021 Newsletter

Focused Ultrasound Against Chronic Pain

Mark V. Kingsley03/09/2021 With the mention of ultrasound, the first thing that may come to mind for many people is black and white photographs of fetuses in the womb. Those images have improved significantly with improvements in technology, and with those improvements, the use of ultrasound is increasingly being recognized as potentially revolutionary in treatment … Continue reading

March 8, 2021 Newsletter

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

March 8, 2021 Press Releases

Right-to-Repair – 2021: Legislate, Regulate, Litigate, or Collaborate?

G. Wayne Moore02/09/2021 There are four paths forward currently being pursued regarding the so-called “Right-to-Repair” issue specific to medical devices; regulation, litigation, legislation, and collaboration. The FDA- initiated 3rd Party Service Docket central to this issue began almost 5 years ago. So, what has happened since March of 2016? The FDA committed to draft a … Continue reading

February 8, 2021 Newsletter