Philips receives U.S. FDA 510(k) clearance to market its solution for 'small parts' ultrasound imaging

10/13/2017

AMSTERDAM and TAIPEI, Taiwan -- Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the new eL18-4 transducer with full solution for 'small parts' assessment, which is an ultrasound exam to detect abnormalities in the small organs that are close to the skin. The Philips Ultimate Small Parts Solution features four key innovations that work together to help improve patient care: the eL18-4 PureWave linear array transducer, Philips MicroFlow Imaging, Philips Elastography and Philips Precision Biopsy. The new eL18-4 transducer can also be used to assess musculoskeletal injuries.  Philips will debut this latest solution, which is available on Philips EPIQ 7 and 5 and Affiniti 70 ultrasound systems, at the 16th World Federation for Ultrasound in Medicine and Biology (WFUMB) Congress in Taipei.

A vital tool for improving patient care, small parts imaging is a rapidly growing segment of ultrasound examinations for clinicians around the world. Its broad set of applications include assessment of diseases and disorders of small organs such as breasts, testicles and thyroid, as well as musculoskeletal injuries like sprains and tears. High-resolution ultrasound, such as that available on Philips EPIQ and Affiniti solutions, allows clinicians to visualize and characterize abnormalities and evaluate organ blood flow, guide treatment and perform biopsies of suspicious lesions.

"The superb image quality derived from Philips' breakthrough, ultra-broadband frequency transducer along with full solution Elastography support, helps clinicians make confident clinical decisions driven by an exam that is easier to perform," said Vitor Rocha, Ultrasound Business Leader at Philips. "With the new Philips Ultimate Small Parts Solution, clinicians now have the power to comprehensively assess and treat small parts and deliver better care for their patients with all-in-one functionality." 

"My clinical experience with the new Philips eL18-4 small parts transducer has enabled excellent versatility and penetration that could easily replace my current transducers," said Dr. Lynwood Hammers, Hammers Healthcare Imaging, New Haven, CT.  "I am able to see subtle lesions with great detail and excellent sensitivity for small vessel details. In my opinion, this new small parts transducer definitely elevates my clinical confidence and decreases indeterminate diagnosis."

New Capabilities Advance Confident Diagnoses  
The Philips EPIQ Ultimate Small Parts Solution is comprised of a suite of features for small parts assessment. These include:     

The Philips eL18-4 transducer, allows fine-elevation focusing to deliver exceptional detail resolution and tissue uniformity for clinical solutions, including: thyroid, breast, testicular, musculoskeletal, vascular, bowel, pediatrics and obstetrics. 

Philips MicroFlow Imaging, provides remarkable sensitivity and detail for small vessel blood flow assessment. 

Complete Elastography solution with both strain and ElastQ Imaging shear wave capability, reveals definitive information on tissue stiffness. 

New precision biopsy capabilities, help minimize needle blind zones and support the ability to enhance the display of needle reflections – all to elevate confidence during interventional procedures.