FDA approves Philips non-invasive elastography for liver assessment

Royal Philips announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its ElastQ Imaging capability, further expanding the functionalities of its EPIQ family of ultrasound systems. ElastQ Imaging enables simultaneous imaging of tissue and assessment of its stiffness, which is essential for the diagnosis of various liver conditions. With ElastQ Imaging, clinicians have a comprehensive solution to assess and diagnose liver conditions without the pain or expense of a liver biopsy.  Using shear wave elastography to focus sound waves to assess soft tissue stiffness, ElastQ Imaging is non-invasive, reproducible and easily executed. Philips is at the forefront of imaging technology innovation, and with this new capability, is addressing a significant need of medical professionals in the clinical setting.

Liver disease, which includes hepatitis B and C, liver cancer and cirrhosis, is a growing global health issue due in part to rising obesity rates and an aging population. Non-alcoholic fatty liver disease affects approximately 20% of the global population. According to the World Health Organization (WHO), total deaths worldwide from cirrhosis and liver cancer rose by 50 million per year over the last two decades, and many cases continue to go undetected.

To determine the stage of liver disease and damage, a liver biopsy is typically performed by extracting a small piece of liver tissue for microscopic examination. Research suggests that instead of costly and painful biopsy procedures, ultrasound exams using shear wave elastography could become routine for assessing liver disease status and may reduce or avoid the need for conventional liver biopsies.

“Philips aims to provide the tools necessary for assessing and managing chronic conditions that so many people face, and liver disease is no exception,” said Vitor Rocha, Ultrasound Business Leader at Philips. “We know that liver disease is a growing health concern around the globe, and we are committed to pioneering innovations like ElastQ Imaging to create our ultimate ultrasound liver solution that offers exceptional clinical performance, further improving patient care.”

Source: Royal Philips

Clarius handheld wireless ultrasound scanner CE approved

Clarius announced that it has CE Mark approval for the commercial sale of the C3 and L7 Clarius Wireless Ultrasound Scanners for use by medical professionals.

“Clarius has amazing image quality for such a small device,” said Dr. Gert-Jan Mauritz, an emergency medicine resident and ultrasound instructor based in the Netherlands.  “It’s better than a traditional ultrasound machine because I carry it everywhere in my pocket and it’s so easy to use the Clarius App on my phone.”

Compact ultrasound systems for use at the bedside are the norm in most hospitals and many private clinics. But costs of high quality systems have been a barrier for more widespread adoption. A basic ultrasound scanner from Clarius will start at €6,600 in European Union countries.

Clarius Scanners are powered by a rechargeable battery, which is easily exchanged when running low. Built with a magnesium case, Clarius Scanners are designed to withstand challenging environments and are water submersible for easy cleaning and disinfection.

Smart-device ultrasound for ambulatory and home use by healthcare professionals

Royal Philips announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its innovative S4-1 cardiac transducer for Lumify, its smart-device diagnostic ultrasound solution. The pocket-sized and lightweight S4-1 transducer now offers advanced sensitivity and exceptional high-resolution 2D image quality, along with new exam pre-sets, allowing clinicians to quickly triage and assess their patients like never before.

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GE Healthcare launches new compact ultrasound system

GE Healthcare announced the global commercial launch of its new generation of high-end portable compact cardiovascular ultrasound, the Vivid™ iq. A smaller sized compact weighing just 4.5 kg, the Vivid™ iq matches exceptional image quality with extraordinary functionality, allowing clinicians to diagnose in more settings than ever before. From the Cath lab and the OR to the ER or even a tented exam room in a remote location, this ultra-portable diagnostic ultrasound system delivers premier cardiac care without compromises.

As GE Healthcare’s most advanced portable cardiovascular ultrasound to date, the Vivid™ iq was developed alongside clinicians and healthcare providers around the world. Dr. Ferran Rosés Noguer, head of the Pediatric Cardiology Department at Vall d’Hebron University Hospital in Barcelona, said: “Vivid iq is a huge step forward in terms of image quality and innovative design. It is extremely user friendly, truly portable, with a fantastic interface and a great design that is really futuristic and elegant at the same time.”

With today’s increasing patient volumes, Vivid™ iq helps adapt to new challenges with the combination of power and portability.

A press release can be found from GE Healthcare website.