FDA clears on-device triage algorithms for critical care from GE HealthCare

The Critical Care Suite 2.1 showing PTX overlay and confidence level. [Image courtesy of GE HealthCare]GE HealthCare (Nasdaq: GEHC) + announced today that the FDA granted 510(k) clearance to its Critical Care Suite 2.1 with a pneumothorax (PTX) algorithm.

The industry-first clearance allows the suite to detect, notify and triage the diagnosis of PTX. Chicago-based GE HealthCare’s updated algorithm expands the suite’s on-device triage capabilities, according to a news release. It provides immediate notification of the presence or absence of PTX, plus an overlay display both on-device and in PACS.

GE HealthCare said its latest update displays an overlay in the area where the suite locates a PTX when detected. It assists with PTX localization and improves the speed and accuracy of PTX diagnosis. By hosting the Critical Care Suite on-device, GE HealthCare makes critical insights available at the point of care acro…

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GE HealthCare unveils AI-powered breast cancer detection suite

GE HealthCare (Nasdaq: GEHC) + announced today that it launched a new, all-in-one AI platform to support breast cancer detection.

The initial release of the GE HealthCare MyBreastAI Suite integrates three AI applications from iCad. That includes the ProFound AI for DBT, part of a platform that iCad today said demonstrates accurate breast cancer risk detection. It also integrates iCad’s SecondLook for 2D Mammography and PowerLook Density Assessment.

Chicago-based GE HealthCare says these apps support early detection, improve patient outcomes and enhance operational productivity.

ProFound AI for DBT provides information like lesion certainty of finding and case scores. These assist in prioritizing caseloads and clinical decision-making while reducing burnout.

SecondLook, a computer-aided detection (CAD) system, identifies and marks regions of interest on screening and diagnostic mammograms from GE Hea…

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GE HealthCare, Masimo collaborate on patient monitoring tech

The Portrait Mobile system. [Image courtesy of GE HealthCare]GE HealthCare (Nasdaq: GEHC) + and Masimo (Nasdaq: MASI) + today announced a joint agreement to integrate patient monitoring technologies.

The agreement aims to integrate Masimo Signal Extraction Technology (SET) pulse oximetry into GE HealthCare’s Portrait Mobile wireless, wearable patient monitoring solution.

Portrait Mobile, built as an internet of medical things (IoMT) platform, uses cloud-native technology. It provides an end-to-end experience for wearable, continuous monitoring. The FDA cleared Portrait Mobile in August of this year.

Integrating Masimo SET enables clinicians to leverage Masimo’s measure-through motion and low-perfusion oxygen saturation (SpO2) measurement technology. It allows for noninvasive detection and continuous monitoring of changes in patient status.

Uses of SET te…

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GE HealthCare stock rises on Street-beating Q3

GE HealthCare (Nasdaq: GEHC) + shares are up today on third-quarter results that came in ahead of the consensus forecast.

Shares of GEHC rose 6.3% at $64.14 apiece in mid-morning trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — rose 1.1%.

The Chicago-based company posted profits of $375 million in the quarter. That equals 82¢ per share on sales of $4.82 billion for the three months ended Sept. 30, 2023. GE HealthCare recorded a 23% bottom-line slide on sales growth of 5.4%.

Adjusted to exclude one-time items, earnings per share came in at 99¢. That landed 9¢ ahead of expectations on Wall Street. GE HealthCare posted a narrow sales beat, topping projections of $4.8 billion in revenue.

The company maintains its revenue guidance for a range between 6% and 8% for the full year. It increased the low end of its adjusted EPS guida…

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The biggest cardiovascular stories from TCT 2023

Every year, some of the biggest names in cardiovascular technologies come together in one place for TCT.

This year’s 35th edition of the Transcatheter Cardiovascular Therapeutics annual scientific symposium was no different in San Francisco.

Usual suspects like Medtronic and Abbott released data covering a range of products, while other big names like Edwards, GE HealthCare and more had positive updates on their own technologies.

Last year’s TCT event highlighted some significant trends in the cardiovascular space. Let’s see what this year’s symposium brought.

Abbott’s TriClip, MitraClip shine along with drug-eluting stent

Results from Abbott’s TRILUMINATE pivotal trial reinforced the safety and effectiveness of the TriClip system. Abbott also shared data from the MitraClip EXPAND G4 real-world registry at TCT 2023.

TriClip, a transcatheter edge-to-edge repair (TEER) system, treats patients with symptomat…

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How can medtech companies innovate their business models?

From left: Veronica Acurio, Gio Di Napoli, Brian Montgomery and Simran Sabharwal talked business model innovation at AdvaMed’s The MedTech Conference.

In an ever-changing medtech space, how do companies keep up with the pace of change? How do companies adjust and innovate their business models to reflect that?

Leaders from some of medtech’s biggest names attempted to answer some questions around that at AdvaMed’s The MedTech Conference yesterday. (Want to find out more? Leaders from major medical device companies will discuss innovation in surgical robotics, diabetes tech, cardiovascular and neurovascular tech, oncology and more at DeviceTalks West, Oct. 18–19 in Santa Clara. Register here.)

A panel on “Disruptive Business Models in Medtech: The Next Frontier of Value-Centric Innovation” included:

Veronica Acurio, president of the Medical Solutions division, 3M; Gio Di Napoli, president of the GI operating unit at Medtronic; B…
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GE HealthCare launches AI-enhanced point-of-care ultrasound

Caption Guidance on the Venue Go system in use. [Image courtesy of GE HealthCare]GE HealthCare (Nasdaq: GEHC) + announced today that it launched its Venue point-of-care ultrasound systems with AI-driven Caption Guidance.

Chicago-based GE HealthCare says the Venue family is the first of its ultrasound guidance to include Caption Guidance. The company added the AI-driven imaging guidance to its arsenal when it acquired Caption Health earlier this year.

Caption Guidance, an optional add-on, offers new capabilities at the point of care with diagnostic-quality cardiac images. It supports clinicians in a wide range of clinical settings, like emergency departments, critical care wards and anesthesiology.

GE HealthCare says the Caption Guidance technology offers clinicians step-by-step instructions to acquire ultrasound for cardiac assessments. It helps providers — even those who aren’t ultrasound experts — by addres…

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Bill & Melinda Gates Foundation gives GE HealthCare $44M to develop AI-based ultrasound

GE HealthCare (Nasdaq: GEHC) + today announced that it received a $44 million grant from the Bill & Melinda Gates Foundation.

The foundation issued the grant for GE HealthCare to create user-friendly, AI-assisted ultrasound imaging auto-assessment tools. These tools could aid healthcare professionals with clinical decision information to support more effective ultrasound scans. Such scans include obstetric and lung screening across maternal and fetal care, as well as pediatric lung health.

Chicago-based GE HealthCare said it hopes to expand access to low- and middle-income countries (LMIC) across diverse care sites. Caption Health — acquired by GE HealthCare in February — will design the technology, according to a news release. It intends to enable it to run across a range of ultrasound devices and probes, including lower-cost handheld devices.

“We are proud and excited to have received this grant from the B…

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GE HealthCare, Mayo Clinic partner on medical imaging, theranostics

Mayo Clinic and GE HealthCare (Nasdaq: GEHC) + today announced a strategic collaboration aimed at improving radiology practice and therapy delivery.

It marks the second collaboration between GE HealthCare and a major hospital this month alone. Last week, the company announced an AI-focused partnership with Massachusetts General Hospital.

The Strategic Collaboration for Innovation in Medical Imaging and Theranostics covers research and product development programs. It includes Mayo Clinic and GE HealthCare scientists, technology developers, clinicians and other healthcare providers.

Mayo Clinic and GE HealthCare aim to better equip clinicians with technology to precisely diagnose and treat medical conditions. They want to personalize the patient experience at each step of the care journey, according to a news release. Mayo and GE HealthCare said they seek to translate novel technologies and approaches to medical …

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GE HealthCare, Mass General collab on AI algorithm to predict missed care opportunities

GE HealthCare (Nasdaq: GEHC) + and Mass General Brigham today announced an effort to co-develop an AI algorithm to increase operations effectiveness and productivity.

The duo announced this development plan as part of their 10-year collaboration, inked in 2017. They aim to develop the application for the schedule predictions dashboard of the Radiology Operations module. This digital imaging tool helps optimize scheduling, reduce cost and free providers from administrative burden. GE HealthCare said this allows more time for the clinician-patient relationship.

“Amid the vast sea of data and the heavy tasks that divert healthcare providers from patient care, our collaboration with Mass General Brigham is groundbreaking. Through the fusion of distinctive datasets and cutting-edge machine learning methods, harnessing the synergy of clinical and technical proficiency, we are ushering in unprecedented healthcare advanc…

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What are the largest medical device companies?

Medtronic, Johnson & Johnson MedTech and Siemens Healthineers again lead the Medtech Big 100 list of largest medical device companies.

However, there is so much more to Medical Design & Outsourcing and MassDevice‘s 2023 edition of the Medtech Big 100 report. We pulled thousands of data points to provide information on annual revenue, R&D spending, headcount, CEOs and key leaders, headquarters locations and descriptions of each of the 100 largest medical device companies.

Senior Editor Danielle Kirsh’s analysis shows that even as the largest medtech companies engaged in layoffs over the past year, they also made a bet on innovation to boost future growth: R&D spending increased nearly 13% to $26.4 billion. (Read the full story on MDO.)

In addition, the full Medtech Big 100 list includes already completed medtech company spinoffs such as Embecta , GE HealthCare and ZimVie.

Read the full Medtech Big 100 report to find out …

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GE HealthCare unveils wireless, handheld ultrasound device

The Vscan Air SL handheld ultrasound device. [Image courtesy of GE HealthCare]GE HealthCare (Nasdaq: GEHC) + announced today that it launched its Vscan Air SL handheld ultrasound imaging system.

The company debuted the first Vscan color pocket-sized ultrasound in 2010. Today, more than 50,000 Vscan platform devices are out in the field. The FDA cleared the initial GE HealthCare Vscan Air CL system in late 2020. The company then launched the device in March 2021.

Vscan Air SL features GE HealthCare’s proprietary SignalMax and XDclear technology. These offerings provide high levels of penetration, resolution and sensitivity in imaging performance through single-crystal transducer technology.

The portable, wireless device enables clinicians to efficiently collect and view clear cardiac and vascular images at the point of care. It offers whole-body scanning and enables the secure viewing of images. Clinicians can…

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