News | Coronavirus (COVID-19) | May 26, 2020

FDA Clears Philips Ultrasound Portfolio to Image COVID-19 Related Lung and Cardiac Complications

Philips’ ultrasound portfolio, including Lumify with Reacts handheld tele-ultrasound solution, provides valuable diagnostic insight for front-line care providers  

The Philips Lumify point-of-care ultrasound (POCUS) system assessing a patient in the emergency room combined with telehealth to enable real-time collaboration with other physicians.

The Philips Lumify point-of-care ultrasound (POCUS) system assessing a patient in the emergency room combined with telehealth to enable real-time collaboration with other physicians.

May 26, 2020  — Philips Healthcare recently received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market a wide range of its ultrasound solutions for the management of COVID-19 (SARS-CoV-2) related lung and cardiac complications. Handheld and portable ultrasound solutions in particular have become valuable tools for clinicians treating COVID-19 patients due to their imaging capabilities, portability and ease of disinfection. As a result of this regulatory clearance, which is an industry first, Philips can provide detailed, practical guidance to support clinicians using its systems and software for patients affected by COVID-19. The clearance applies to Philips ultrasound systems including the Epiq series, Affiniti series, Lumify, CX50 and Sparq diagnostic ultrasound systems, and to off-cart solutions like QLab Advanced Quantification Software.

Ultrasound has shown value in imaging peripheral lung tissue affected by pneumonia, which  is closely tied to COVID-19 lung complications. As respiratory strain can also lead to cardiac dysfunction, COVID-19 patients are at increased risk for cardiac complications. A cardiac ultrasound exam can help in evaluating the effects that disease progression may have on heart function. By imaging COVID-19 patients at the point of care, such as in the emergency department (ED) or intensive care unit (ICU), clinicians can diagnose and monitor patients without the need to move them around the hospital, helping to reduce the risk of virus transmission to other patients or to healthcare professionals.

“Many healthcare providers have told us that our handheld and portable ultrasound solutions are playing a valuable role in their efforts to combat COVID-19,” said Bich Le, senior vice president and general manager ultrasound at Philips. “With this regulatory clearance we can offer clear guidance to ensure safe and effective use of ultrasound to manage COVID-19-related lung and cardiac complications. At the same time, we are investing significantly to ramp up production globally, including at our ultrasound manufacturing plants in the U.S.”

With its broad portfolio, leadership in areas including cardiac ultrasound and the unique capabilities of the Lumify with Reacts handheld tele-ultrasound solution, Philips is well positioned to support healthcare providers with ultrasound solutions as they combat the pandemic. The Lumify with Reacts point-of-care ultrasound solution, which works in conjunction with a compatible smartphone or tablet, is the world’s first ultra-portable ultrasound device with advanced telehealth capabilities. The Reacts communications platform enables two-way audio-visual calls with live ultrasound streaming, so both parties can simultaneously view the live ultrasound image and probe positioning, while discussing and interacting at the same time. In the context of COVID-19, this solution can help minimize the risk of virus transmission for the medical team.

The new guidance highlights the specific presets, transducers, quantification tools and other capabilities available on Philips’ ultrasound systems that are relevant in assessing and managing COVID-19-related lung and cardiac complications. For example, the Epiq CVx premium cardiology ultrasound system includes automated applications for 2-D assessment of the heart, as well as robust 3-D right ventricle volume and ejection fraction measurements. 

The regulatory clearance includes the following Philips ultrasound systems: Epiq series, Affiniti series, Lumify, CX50, and Sparq diagnostic ultrasound systems and off-cart solutions like QLab Advanced Quantification Software. 

For moor information: www.usa.philips.com/healthcare/medical-specialties/covid-19/ultrasound

Related Content

A cardiac MRI of athletes who had COVID-19 is seven times more effective in detecting inflammation of the heart than symptom-based testing, according to a study led by researchers at The Ohio State University Wexner Medical Center and College of Medicine with 12 other Big Ten programs.

Cardiac Magnetic Resonance Imaging in Athletes With Clinical and Subclinical Myocarditis A-D, Athlete A with subclinical possible myocarditis was asymptomatic with normal electrocardiogram (ECG), echocardiogram, and high-sensitivity troponin findings. A, T2 mapping showing elevated T2 in basal-mid inferolateral wall in short axis view. B, late gadolinium enhancement (LGE) in the basal inferolateral wall in short axis view. C, Postcontrast steady state-free precession (SSFP) images showing contrast uptake in the basal-mid inferolateral wall in short axis view. D, LGE in the inferolateral wall in 3-chamber view. E-H, Athlete B with subclinical probable myocarditis was asymptomatic with normal ECG, normal echocardiogram, and elevated high-sensitivity troponin findings. E, T2 mapping showing elevated T2 in the anteroseptal wall in short axis view. F, LGE in the anteroseptal wall in 3-chamber view. G, T2 mapping showing elevated T2 in the anteroseptal wall in 3-chamber view. F, Postcontrast SSFP image showing pericardial effusion in short axis view. I-K, Athlete C with clinical myocarditis and chest pain, dyspnea, abnormal ECG, normal echocardiogram, and normal troponin findings. I, T2 mapping showing elevated T2 in the lateral wall short axis view. J, Postcontrast SSFP images showing contrast uptake in midlateral wall in short axis view. K, LGE in the epicardial midlateral wall in short axis view. L-N, Athlete D with clinical myocarditis, chest pain, abnormal ECG, echocardiogram, and troponin findings. L, T1 mapping showing elevated native T1 in midlateral wall in short axis view. M, T2 mapping showing elevated T2 in the midlateral wall in short axis view. N, LGE in the epicardial midlateral wall in short axis view. IR indicates inferior right view; IRP, inferior, right, posterior view; PLI, posterior, left, inferior view; SL, superior left view; SLA, superior, left, anterior view. Image courtesy of JAMA Cardiol. Published online May 27, 2021. doi:10.1001/jamacardio.2021.2065

News | Cardiac Imaging | June 15, 2021
June 15, 2021 — A...
Rensselaer algorithm can identify risk of cardiovascular disease using lung cancer scan #CT
News | Cardiac Imaging | June 14, 2021
June 14, 2021 — Heart disease and cancer are the ...
Women’s Heart Attack Research Program (HARP) shows combining OCT and cardiac MRI can detect the underlying cause of heart attack in women who did not have blocked arteries

The Women’s Heart Attack Research Program (HARP) study shows combining OCT and cardiac MRI can help detect the underlying cause of heart attacks in women who did not have blocked arteries.

News | Cardiac Imaging | November 17, 2020
November 17, 2020 — Diagnostic imaging techniques were able to find the underlying cause of heart attack in many wome
An example of a CT coronary artery calcium scoring exam showing how each vessel segment is scored to assess a patient's risk for a future heart attack. Example is from Philips Healthcare.

An example of a CT coronary artery calcium scoring exam showing how each vessel segment is scored to assess a patient's risk for a future heart attack. Example is from Philips Healthcare.

News | Cardiac Imaging | September 25, 2020
September 25, 2020 — A study out of University Hospitals (UH) found that removing the cost barrier for coronary arter
Rafael Rivero, M.D., Global Head of Medical Affairs at MSI, said: "The importance of MyoStrain cannot be understated because of the test's immense clinical value and ability to quantify intramyocardial dysfunction across 48 segments of the heart. In a six-heartbeat MRI scan, MyoStrain arms physicians with novel clinical information about a patient's heart health."
News | Cardiac Imaging | August 11, 2020
August 11, 2020 — Myocardial Solutions, Inc. and United Imaging, Inc.
The Mindways Solid phantom with volume of interest in the quality assurance phantom (red circles, left side). A participant's noncontrast-enhanced axial CT (right side) with volume of interest (yellow circles) in the trabecular bone compartment of three vertebrae for bone mineral density measurements. Image courtesy of Radiological Society of North America

The Mindways Solid phantom with volume of interest in the quality assurance phantom (red circles, left side). A participant's noncontrast-enhanced axial CT (right side) with volume of interest (yellow circles) in the trabecular bone compartment of three vertebrae for bone mineral density measurements. Image courtesy of Radiological Society of North America

News | Cardiac Imaging | July 15, 2020
July 15, 2020 — ...
Cardiac MR can offer data above and beyond anatomical imaging, which is the main reason why this system was installed at Baylor Scott White Heart Hospital in Dallas. The system is a dedicated heart MRI scanner.

Cardiac MR can offer data above and beyond anatomical imaging, which is the main reason why this system was installed at Baylor Scott White Heart Hospital in Dallas. The system is a dedicated heart MRI scanner.

News | Cardiac Imaging | June 29, 2020
June 29, 2020 — A type of smart magnetic r...