To screen COVID-19 patients for heart problems, FDA clears several ultrasound, AI devices from Philips, Eko, Caption Health

Patients with preexisting cardiovascular diseases have a higher risk of dying from COVID-19, according to the American College of Cardiology. At the same time, novel coronavirus infections can directly weaken a person’s heart muscle—leading to heart failure, arrhythmias and changes in their ECG—regardless of their previous medical history.

To help detect and diagnose these complications, the FDA authorized devices and algorithms from Philips, Eko and Caption Health this week—which are also, in part, designed to help limit healthcare providers’ exposure to the disease.

Philips received a full 510(k) clearance for several of its portable and point-of-care ultrasound systems, with many handheld components made to be easily disinfected after use. In addition, performing cardiac ultrasound exams within an emergency department, intensive care unit or specially designated ward can reduce the risk of virus transmission to other locations within a hospital.

The clearance covers the company’s EPIQ, Affiniti, Lumify, CX50 and Sparq diagnostic ultrasounds, as well as its QLAB Advanced Quantification Software, for use against COVID-19. This also includes imaging peripheral lung tissue affected by pneumonia and other lung-based complications.

“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 of Philips’ ultrasound efforts. “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.”

In addition, Philips’ Lumify system includes a handheld tele-ultrasound solution that streams the images live over a video call, allowing a separate medical team to offer guidance on probe position and other aspects of the procedure over a smartphone or tablet while conserving personal protective equipment.

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The FDA also expedited a new clearance for Caption Health’s artificial-intelligence-guided ultrasound device, designed to walk providers through a cardiac imaging procedure without any specialized training.

First approved in February, the company said it received an agency go-ahead for its updated version in just 25 days. By providing real-time instructions and feedback, the system’s AI analyzes live image quality and gives suggestions on how to move and position the ultrasound’s transducer to improve clarity.

This can help more front-line hospital staff conduct exams on their own, reducing exposures to sonography personnel. The new version of Caption’s software, available integrated with Terason’s 3200T ultrasound system, includes more types of guidance and improvements in the algorithm’s performance.

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Meanwhile, the FDA also issued an emergency use authorization to Eko for its ECG-based algorithm that screens patients for low ejection fraction, a sign of progressing heart failure and a significant risk for COVID-19 patients.

Developed in collaboration with the Mayo Clinic, the algorithm previously received a breakthrough designation from the agency in December 2019. The new authorization allows providers to use the software to analyze standard 12-lead ECG scans to help spot any signs of ventricular dysfunction. 

Eko co-founder and CEO Connor Landgraf said the company will first begin offering its screening software through the Mayo Clinic before expanding its use to other providers using its platform.

“Given the danger COVID-19 poses to patients with a weak heart pump, it’s important that we rapidly identify these individuals early and monitor them closely,” said Paul Friedman, chair of the Mayo Clinic’s Department of Cardiovascular Medicine.

“By embedding the heart failure screening AI into a quick, widely available, and safe test using existing medical devices, we can detect heart failure early and start appropriate treatments,” Friedman said. “Additionally, for people with COVID-19, we may be able to identify when the virus causes the development of a weak heart pump quickly, safely, and easily using these AI tools.”