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Royal Philips Scores 510(k) for Liver Fat Quantification Tool

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November 23, 2021

Health tech conglomerate Royal Philips announced a new FDA clearance for its Liver Fat Quantification tool, which is part of its telehealth-enabled ultrasound system the EPIQ Elite and Affiniti.

The newly 510(k)-cleared product is aimed at helping clinicians non-invasively diagnose early-stage fatty liver disease. Clinicians using the tool in the EPIQ Elite or Affiniti system can remotely access on-demand and real-time guidance and decision support through Collaboration Live.

The Liver Fat Quantification tool can work on multiple transducers in order to accommodate different body types.

WHY IT MATTERS

According to the CDC, 4.5 million individuals have been diagnosed with liver disease. Risk factors for liver disease include heavy alcohol use, obesity, Type 2 diabetes, tattoos or piercings, unprotected sex, and a family history of the condition, according to the Mayo Clinic.

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Philips is pitching this new technology as a way to help patients find out more about their liver condition – and with that information make health decisions.

“Today’s announcement demonstrates the continued advancement of our ultrasound portfolio to increase diagnostic confidence and workflow efficiency,” Jeff Cohen, general manager of Ultrasound at Philips, said in a statement.

“Accessible ultrasound-based Liver Fat Quantification is a screening and early diagnostic tool that will allow many more patients to take their health into their own hands by making simple lifestyle changes.”

THE LARGER TREND

Philips has been interested in the digital health space for a long time. Over the summer, the company added two new products to its HealthSuite, including one for patient flow capacity and a second for telehealth in the acute care space.

Early in 2021, the company launched its Philips Medical Tablet, a portable monitoring kit designed to help clinicians remotely monitor larger patient populations during emergency healthcare situations like the COVID-19 pandemic.

Philips has also had a historical interest in the ultrasound space. In 2015, it landed clearance for Lumify, a handheld telehealth ultrasound product in Japan. The company said that the technology can be used in the maternity space and beyond.

Source: Mobihealthnews

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