GE HealthCare Receives FDA Clearance for Portrait VSM, Building on Its Growing Ecosystem of Connected Patient Monitoring Solutions

CHICAGO--(BUSINESS WIRE)--Apr 29, 2024--

GE HealthCare (Nasdaq: GEHC) today announced it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for its Portrait VSM vital signs monitor that can provide clinicians with an accurate view of patient vital signs to support timely clinical decisions. As the next evolution of the DINAMAP legacy, Portrait VSM utilizes the SuperSTAT non-invasive blood pressure algorithm to provide precise and accurate measurement readings. Through its wireless connectivity and seamless EMR integration, the portable vital signs monitor was designed with the user workflows in mind, offering customized Early Warning Scores (EWS) and enabling care teams to focus on taking care of their patients by automating routine tasks.

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Building on GE HealthCare’s family of Portrait monitoring solutions, Portrait VSM can connect with the latest iteration of the Portrait Mobile wireless and wearable continuous monitoring solution to seamlessly integrate patient data in one unified workflow, while ensuring patient mobility. Through a single click of the barcode scanner, Portrait VSM automatically imports the patient demographic data and a snapshot of the patient’s continuously monitored data - respiratory rate, oxygen saturation and pulse rate - from Portrait Mobile. This workflow streamlines the process of clinical rounding and reduces the steps needed to capture and chart a complete set of vital sign measurements.

A connected workflow and EMR integration can help enable accurate vital sign charting and eliminate the delay from manual data entry to support clinicians in making timely and confident treatment decisions. 1,2 The uninterrupted flow of data and continuous measurement of vital signs, enabled by Portrait Mobile, can also help clinicians detect patient decline as it is happening, enabling timely intervention before a patient deteriorates.

Patients’ vital signs are typically measured by traditional spot check methods every 4-6 hours, which can cause early signs of patient deterioration to be missed. Undetected patient deterioration, particularly post-surgery, can lead to hazardous yet preventable consequences, with 30-day mortality after surgery representing the 3rd leading cause of death globally. 3 To optimize patient care, Portrait VSM brings together standard spot check capability with continuous patient monitoring through its connectivity to Portrait Mobile.

“We remain focused on tackling healthcare’s biggest challenges and driving further efficiencies for care teams through new patient monitoring technology. To help ease the way to more confident care, Portrait VSM offers the clinical performance and capabilities that care teams can trust, so they can spend more valuable time with their patients,” said Neal Sandy, general manager, monitoring solutions, GE HealthCare. “With the addition of Portrait VSM, we are excited about this next step for the Portrait Ecosystem that was designed to support the right level of patient monitoring in observational care through a single, unified workflow.”

GE HealthCare’s Reimagining Better Health study highlighted the burden of inputting and accessing data manually, with nearly half of clinicians reporting that medical technologies at their facilities do not seamlessly integrate with each other.* Portrait VSM offers workflow efficiencies and capabilities to support hospitals and care teams in navigating current challenges they’re facing. Healthcare systems can incorporate and customize EWS protocols into the monitor view to help clinicians recognize the early signs of deterioration in patients and make timely interventions, while limiting manual calculations and transcription. To enable simplified rounding and help avoid delayed measurements, the Round Advisor feature also helps care teams manage and prioritize spot checks for multiple patients by assigning and tracking a sequence of care.

Built on a well-established history of clinical advancements, GE HealthCare’s FlexAcuity monitoring solutions are engineered to adapt to rapidly changing patient needs. GE HealthCare’s technology has been recognized globally for its design, receiving the iF Design Gold Award for Product Design in 2022 for Portrait Mobile and an iF Design Award in 2023 for CARESCAPE Canvas.

For more information on Portrait VSM and GE HealthCare’s family of Portrait monitoring solutions, please visit: https://www.gehealthcare.com/products/patient-monitoring/portrait-vsm.

*Reimagining Better Healthsurvey questions addressed respondents’ general perception and experience with technology within their facilities and made no reference to any specific solutions or vendors. References in the study are inclusive of the entire spectrum of medical technology, such as medical devices, software solutions, electronic patient records and other digital workflow solutions.

About GE HealthCare Technologies Inc.
GE HealthCare is a leading global medical technology, pharmaceutical diagnostics, and digital solutions innovator, dedicated to providing integrated solutions, services, and data analytics to make hospitals more efficient, clinicians more effective, therapies more precise, and patients healthier and happier. Serving patients and providers for more than 125 years, GE HealthCare is advancing personalized, connected, and compassionate care, while simplifying the patient’s journey across the care pathway. Together our Imaging, Ultrasound, Patient Care Solutions, and Pharmaceutical Diagnostics businesses help improve patient care from diagnosis, to therapy, to monitoring. We are a $19.6 billion business with approximately 51,000 colleagues working to create a world where healthcare has no limits.

Follow us on LinkedIn, X(formerly Twitter), Facebook, Instagram, and Insights for the latest news, or visit our website https://www.gehealthcare.com/ for more information.

Portrait VSM was designed with the user workflows in mind, offering customized Early Warning Scores and enabling care teams to focus on taking care of their patients by automating routine tasks. (Photo: Business Wire)

Portrait VSM was designed with the user workflows in mind, offering customized Early Warning Scores and enabling care teams to focus on taking care of their patients by automating routine tasks. (Photo: Business Wire)

Portrait VSM was designed with the user workflows in mind, offering customized Early Warning Scores and enabling care teams to focus on taking care of their patients by automating routine tasks. (Photo: Business Wire)

WASHINGTON (AP) — The Supreme Court on Thursday rejected a conservative-led attack that could have undermined the Consumer Financial Protection Bureau.

The justices ruled 7-2 that the way the CFPB is funded does not violate the Constitution, reversing a lower court and drawing praises from consumers. Justice Clarence Thomas wrote the majority opinion, splitting with his frequent allies, Justices Samuel Alito and Neil Gorsuch, who dissented.

The CFPB was created after the 2008 financial crisis to regulate mortgages, car loans and other consumer finance. The case was brought by payday lenders who object to a bureau rule that limits their ability to withdraw funds directly from borrowers' bank accounts. It's among several major challenges to federal regulatory agencies on the docket this term for a court that has for more than a decade been open to limits on their operations.

The CFPB, the brainchild of Democratic Sen. Elizabeth Warren of Massachusetts, has long been opposed by Republicans and their financial backers. The bureau says it has returned $19 billion to consumers since its creation.

Unlike most federal agencies, the consumer bureau does not rely on the annual budget process in Congress. Instead, it is funded directly by the Federal Reserve, with a current annual limit of around $600 million.

The federal appeals court in New Orleans, in a novel ruling, held that the funding violated the Constitution’s appropriations clause because it improperly shields the CFPB from congressional supervision.

Thomas reached back to the earliest days of the Constitution in his majority opinion to note that “the Bureau's funding mechanism fits comfortably with the First Congress' appropriations practice.”

In dissent, Alito wrote, “The Court upholds a novel statutory scheme under which the powerful Consumer Financial Protection Bureau (CFPB) may bankroll its own agenda without any congressional control or oversight.”

The CFPB case was argued more than seven months ago, during the first week of the court’s term. Lopsided decisions like Thursday's 7-2 vote typically don't take so long, but Alito's dissent was longer than the majority opinion, and two other justices, Elena Kagan and Ketanji Brown Jackson, wrote separate opinions even though they both were part of the majority.

Consumer groups cheered the decision, as did a bureau spokesman.

“For years, lawbreaking companies and Wall Street lobbyists have been scheming to defund essential consumer protection enforcement," bureau spokesman Sam Goldford said in a statement. “The Supreme Court has rejected their radical theory that would have devastated the American financial markets. The Court repudiated the arguments of the payday loan lobby and made it clear that the CFPB is here to stay.”

Jesse Van Tol, president and CEO of the National Community Reinvestment Coalition, said the decision upholding the consumer bureau's funding structure would have positive effects across the U.S. economy.

“It’s always nice to see the courts get something right — especially in this tawdry circumstance where payday loan predators sought to wriggle out of basic oversight using absurd distortions of law and fact,” Van Tol said in a statement.

While the U.S. Chamber of Commerce and some other business interests backed the payday lenders, mortgage bankers and other sectors regulated by the CFPB cautioned the court to avoid a broad ruling that could unsettle the markets.

In 2020, the court decided another CFPB case, ruling that Congress had improperly insulated the head of the bureau from removal. The justices said the director could be replaced by the president at will but allowed the bureau to continue to operate.

This story has been corrected to show the bureau spokesman’s surname is Goldford, not Gifford.

Follow the AP’s coverage of the U.S. Supreme Court at https://apnews.com/hub/us-supreme-court.

FILE - Sen. Elizabeth Warren D-Mass., speaks to reporters outside the U.S. Capitol, April 23, 2024, in Washington. Consumer groups are praising the Supreme Court's rejection of a conservative-led attack that could've undermined the Consumer Financial Protection Bureau. The justices ruled Thursday the way the bureau is funded does not violate the Constitution. The bureau was the brainchild of Democratic Sen. Elizabeth Warren of Massachusetts and was created after the 2008 financial crisis to regulate consumer finance including mortgages and car loans. (AP Photo/Mariam Zuhaib, File)

FILE - The U.S. Supreme Court is seen, April 25, 2024, in Washington. (AP Photo/Mariam Zuhaib, File)

Supreme Court sides with the Consumer Financial Protection Bureau, spurning a conservative attack

Supreme Court sides with the Consumer Financial Protection Bureau, spurning a conservative attack

FILE - The U.S. Supreme Court is seen, April 25, 2024, in Washington. (AP Photo/Mariam Zuhaib)