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Cranfield, UK, 4th June 2024 – In this monthly news round up, I offer some of the latest news and developments impacting the clinical care markets that caught my eye in recent weeks, including my thoughts on the implications for the market.
1 – GE HealthCare Receives FDA Clearance for Portrait VSM, Building on Its Growing Ecosystem of Connected Patient Monitoring Solutions
This one just missed the April update – so is a first mention for my May update. As apparent in many of my previous newsletters, GE HealthCare has been making significant strides in establishing its newest entrants into its patient monitor portfolio. Both the Canvas and Portrait portfolio received initial FDA approvals in 2023. The latest to receive FDA approval is its Portrait VSM solution, which builds on the wider Portrait portfolio with the addition of its DINAMAP SuperSTAT non-invasive blood pressure monitor. It combines what GE HealthCare terms “Smart cuff” pressure control with its SuperSTAT algorithm to ensure more precise and accurate readings. The solution further enhances the Portrait platform, to provide a combination of SpO2 and temperature with non-invasive blood pressure monitoring to round out the ability to monitor the main patient vital signs. In combination with its inbuilt Early Warning Scoring System, GE HealthCare is targeting the growing need to monitor patients in lower-acuity settings, helping to combat the issues seen in under resourced health facilities. GE HealthCare had also announced at the end of April that it had been named as the founding member of the N+1 Institute at the University of Wisconsin–Madison. The collaboration with the N+1 institute will enable both parties to explore artificial intelligence (AI) and edge computing to improve precision and flexibility in patient monitoring technology. The partnership will enable developments in edge computing technology in patient monitoring to help support clinicians by providing real-time, critical patient care. In support of students enrolled within the research projects, they will also be able to access first-hand the monitoring solutions such as the Portrait monitoring platform. In Signify Research’s most recent update on the patient monitor market, GE HealthCare gained share across the patient monitoring market in 2023, further cementing its strategic efforts to provide flexible monitoring options, forcing other vendors to take note of their expanding presence.
2 – Clew Medical Obtains FDA Approval for Next Generation AI solution
Focusing on improving patient outcomes, Clew Medical has recently received FDA approval for its next generation AI analytics tool. Clew Medical initially gained FDA approval in 2021, claiming the title to be the first, Class II device to provide AI-based predictive analytics for patient deterioration in the ICU (8 hours in advance based on hemodynamic instability). As part of the newest update to the Clew prediction models, the FDA has approved its pre-authorized change control plan (PCCP), allowing specific future modifications to the system’s input data without requiring a new 510(k) application. The approval also followed Clew Medical’s announcement that its predictive patient deterioration model can also be deployed beyond the ICU in all inpatient settings. The move will allow Clew Medical to further penetrate other settings that are looking for informative tools to reduce the risk of patient deterioration and highlighting when intervention may be required. With the trend to up-level the continuous monitoring facilities in step-down and general ward settings, analytic tools such as that from Clew Medical will further ensure patient deterioration is identified early to reduce avoidable events.
3 – The Cardiology market Continues to see Swathes of Innovation, Collaboration and new Product Launches
In the wake of the annual congress of the Heart Rhythm Society, the cardiac market has been awash with several announcements. The most notable to the Signify Research analyst team have been highlighted below:
a) Implicity Gains FDA Approval for Heart Failure Prediction Algorithm
Earlier this month Implicity announced that it had gained Class II FDA approval for its SignalHF AI-based algorithm for the assessment and the prediction of the risk of heart failure. The SignalHF analyses patient data from implantable cardiac devices against the Health Data Hub, a database of patients with heart diseases. The algorithm benchmarks the patient’s data against the database to determine subtle trends that indicate that the patient’s condition is worsening. Care teams are automatically notified when the patient’s risk score crosses an established threshold, highlighting if the patient is at high risk of experiencing heart failure and being hospitalised in the near future. It claims that 75% of the alerts preceding a hospitalisation are sent at least 14-days in advance. Implicity’s approach to preventative care enables care providers to adapt the patient’s treatment to reduce their risk of further deterioration to help avoid unnecessary admissions.
b) Cardiomatics partners with BIOTRONIK in Germany to expand market access of its advanced AI-powered ECG analysis solution
Cardiomatics, a Polish-based provider of cloud-based AI-ECG interpretation software has announced that it has partnered with German-based BIOTRONIK to enable the expansion of its solution. As part of the relationship, BIOTRONIK’s sales organisation in Germany will distribute Cardiomatics’ AI-powered ECG analysis software alongside BIOTRONIK’s net_ECG advanced ECG-Patch Holter Monitor. Cardiomatics first received European medical device certification in 2018 and has since received European medical device certification, one of the first AI applications to do so. Its cloud-based platform uses proprietary algorithms to detect and analyse 21 heart abnormalities and disorders. The platform is device agnostic, currently integrating with ECG devices from 25 vendors. The relationship will see both companies revolutionising the early detection and management of cardiac events using the synergies of both company’s solutions.
c) Omron and AliveCor partner in India
AliveCor has further expanded its global reach through its more recent partnership with Omron Healthcare in India. The collaboration will target the growing incidence of hypertension in the country by combining Omron’s BPM+ECG Complete Monitoring FDA cleared Device (blood pressure monitor with AliveCor ECG capability in a single device) for early CVD (cardiovascular disease) detection and management, and AliveCor’s KardioMobile (FDA-cleared world’s most clinically-validated and pocket-sized personal ECGs). Omron Healthcare has been an investor into AliveCor for several years, with its first collaboration in 2019, in which the AliveCor and Omron Healthcare developed the first FDA-cleared blood pressure monitor with integrated ECG capability within the single device. In 2020, Omron Healthcare also led a $65 million seed E funding for AliveCor. The joint collaboration will advance both company’s offerings to the Indian market and will help to increase their access to a growing population to help reduce their risk of cardiovascular disease.
d) Philips present study to demonstrate benefit of AI in cardiac monitoring
Whilst at the HRS 2024 congress, Philips presented its study that it had recently published in the The Journal of Comparative Effectiveness Research. The study analysed the clinical and economic outcomes of utilising Philips mobile cardiac outpatient telemetry (MCOT) wearable ECG sensor compared with implantable loop recorders (ILRs) to determine how cardiac remote monitoring technology impacts current standards of care for stroke patients. The study highlighted the benefits of using MCOT instead of ILRs for post-discharge monitoring. It found that patients had significantly lower levels of readmission, reduced cost of treatment and reduced utilisation of emergency departments. Whilst at the show, Philips also demonstrated two posters, highlighting the company’s impact on improved health outcomes and AI-driven diagnosis:
- Back to the Future: Artificial intelligence applied to ECG can help identify life-threatening arrhythmia events at the roots – an assessment of how Philip’s AI-powered ECG biomarker technology can help to identify patients with significant intermittent bradyarrhythmia, potentially improving timely diagnosis and management.
- The EP-COT Trial: Impact of Emergent Physician Notifications from MCOT on Patient Outcomes – identifying the use of MCOT data notifications to initiate unscheduled follow-ups and procedural intervention, indicating the effectiveness of MCOTs to intervene and provide necessary care.
e) WearLinq Acquires AMI Cardiac Monitoring LLC
WearLinq, a provider of a 6-lead wireless wearable ECG monitor, has announced its strategic acquisition of AMI Cardiac Monitoring, LLC, an established dependent diagnostic testing facility (IDTF) and a provider of holter monitoring solutions. The acquisition of AMI follows the completion of a recent $6.7 million funding round, which led to investment from SpringTide, Social Impact Capital, Amino Capital, Berkeley Catalyst Fund, Human Longevity and angels from iRhythm and AliveCor. WearLinq obtained 510k clearance for its eWave Monitor in 2022, which has a single-charge design and is capable of integration with the patient’s mobile phone. By combining AMI into its broader portfolio of solutions, WearLinq will be able to further expand its offering of short-term and long-term ECG monitoring to the US market. This strategic approach was further cemented by the announcement that joint inventor of iRhythm’s ZioPatch, has joined WearLinq’s Board of Directors.
f) FDA qualifies Apple Watch AFib feature for use in clinical trials
The FDA has announced that the Apple Watch AFib history feature has been approved as a tool within the Medical Device Development Tools (MDDT) program. The MDDT is a set of tools that can be used to help qualify clinical studies used to evaluate a new medical device. There are 3 categories in which the tools have been assigned according to how the tool measures the relevant parameters. The 3 groups include:
- Non-clinical Assessment Model (NAM) a non-clinical test model or method that measures or predicts parameters of interest in regard to device safety, effectiveness, or device performance.
- Biomarker Test (BT) a test or instrument used to detect or measure a biomarker. A biomarker test can be used to assess risk, or identify safety concerns, or predict treatment outcomes in patients.
- Clinical Outcome Assessment (COA) describes or reflects how a person feels, functions, or survives and can be reported by a health care provider, a patient, a non-clinical observer (such as a parent), or through performance of an activity or task. COAs could be collected in the clinic or remotely (e.g., collected with the use of digital health technologies).
The AFib feature from Apple has been designated as a Biomarker Test tool which according to its designation ‘can be used as a biomarker test to help evaluate estimates of AFib burden as a secondary effectiveness endpoint within clinical studies intended to evaluate the safety and effectiveness of cardiac ablation devices’. The tool can be used to collect weekly AFib burden information during clinical studies. The FDA also claims that the ‘tool may aid in better understanding AFib burden in patients while providing supplemental data to more clinically well-defined endpoint.’
Signify Research’s most recent reports include new analysis on the Infusion Pumps, Fetal Monitors, AI in Diagnostic cardiology and Hospital-At-Home markets. We also have several new reports publishing soon:
- Ventilators available this week!.
- Patient Monitors available in June.
- Diagnostic Cardiology available in June
We welcome further conversations on the trends specifically impacting the markets highlighted.
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About Kelly Patrick
Kelly joined Signify Research in 2020 as a Principal Analyst. She has over 15 years’ experience covering a range of healthcare technology research at IHS Markit/Omdia. Kelly’s core focus has been on the Clinical Care sector, including patient monitoring, diagnostic cardiology, respiratory care, and infusion and associated IT solutions. Kelly holds a BSc degree with honours in Pharmacology from the University of Leeds. In her spare time, Kelly has a passion for running and outings with her husband and three children.
About the Clinical Care Team
The clinical care team provides market intelligence and detailed insights on the clinical care equipment and IT markets. Our areas of coverage include patient monitoring, diagnostic cardiology, infusion pumps, ventilators, anaesthesia devices, and high-acuity IT. Our reports provide a data-centric and global outlook of each market with granular country-level insights. Our research process blends primary data collected from in-depth interviews with healthcare professionals and technology vendors, to provide a balanced and objective view of the market.
About Signify Research
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