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GE Healthcare receives FDA approval for Change in contraindications in prescribing information for Optison

Press releases may be edited for formatting or style | October 05, 2021 Ultrasound

GE Healthcare has a legacy of industry-defining innovations in ultrasound including having introduced the world’s first high resolution 4D fetal ultrasound system, the first handheld ultrasound and the world’s first ultrasound optimized for AI.

About GE Healthcare:
GE Healthcare is the $18 billion healthcare business of GE (NYSE: GE). As a leading global medical technology, pharmaceutical diagnostics and digital solutions innovator, GE Healthcare enables clinicians to make faster, more informed decisions through intelligent devices, data analytics, applications and services, supported by its Edison intelligence platform. With over 100 years of healthcare industry experience and around 47,000 employees globally, the company operates at the center of an ecosystem working toward precision health, digitizing healthcare, helping drive productivity and improve outcomes for patients, providers, health systems and researchers around the world.


About Optison:
Optison was the first ultrasound enhancing agent (UEA) introduced to the market over 20 years ago. It helps clinicians to better visualize the left ventricle in previously suboptimal echocardiograms. It can enhance image quality of the left ventricle and the endocardial borders compared to unenhanced images. It also helps workflow efficiency related to preparation, administration, portability and storage attributes. Optison is stable at room temperature for up to 24 hours and is quick to prepare, allowing for quick access to the UEA in hospital settings like the echo lab, intensive care unit or emergency room. It has a well-established safety profile, and is the only UEA in the US that does not contain polyethylene glycol (PEG). PEG containing UEAs are contraindicated for patients with hypersensitivity to PEG. Optison does not contain preservatives and is for single patient use only. Healthcare professionals should follow labelled instructions for product handling and use and discard unused product properly.

Optison is not for use in patients with known or suspected hypersensitivity to perflutren or albumin. As for all ultrasound enhancing agents, Optison has a Boxed Warning indicating that serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following perflutren-containing microsphere administration. Most serious reactions occur within 30 minutes of administration. Healthcare professionals should assess all patients for the presence of any condition that precludes Optison administration and always have resuscitation equipment and trained personnel readily available.

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