Clinical Care News Round Up - November 2024
29th November 2024
November saw a number of interesting developments in the Clinical Care market, particularly related to the wearables space:
Featuring news from Dexcom , ōURA , OMRON Healthcare, Inc. , Anumana , HeartSciences (NASDAQ:HSCS) , Eko Health , SmartCardia , smartQare , Neways Electronics International NV , AliveCor , Fourth Frontier , OmnySense , CardioComm Solutions Inc. , Sony Network Communications Europe , Rapid Response Revival?
As we rapidly approach the end of the year (and the mid-point of the decade!) there were plenty of newsworthy developments in the Clinical Care market in November.
Dexcom and ōURA announce strategic partnership
One of the biggest stories in November was the announcement of a strategic partnership between continuous glucose monitoring (CGM) vendor Dexcom and Finnish smart-ring vendor ōURA. The partnership will see the integration of data flow between Dexcom and ōURA products, including Dexcom glucose biosensors, Dexcom apps, Oura Ring and the Oura App. This will enable shared users to track their glucose levels and understand the impact of behaviours and biology on their metabolic health. The partnership also includes a $75 million Series D investment by Dexcom in ōURA, valuing the latter at over $5 billion.
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Omron receives FDA De Novo authorisation for new AFib-detecting Blood Pressure Monitor
Sticking with the theme of home-based patient monitoring, November saw blood pressure monitor market leader Omron revealing FDA De Novo authorisation for its new AI-powered IntelliSense AFib BP monitor. In what the company claims to be an industry first, the device’s IntelliSense AFib algorithm can detect Atrial Fibrillation by analysing the Pressure Pulse Wave generated during blood pressure measurement. Following the approval, Omron plans to launch a series of new upper arm blood pressure monitors with advanced AFib detection in the U.S. in early 2025.
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AI-ECG reimbursement breakthroughs for Anumana, HeartSciences and Eko Health
In a sign that the AI-ECG market could be ready for take-off in 2025, the Centers for Medicare & Medicaid Services (CMS)?has included the technology in its 2025 Hospital Outpatient Prospective Payment System (OPPS) final rule under assignment APC 5734. This will allow outpatient settings to receive reimbursement for using both Anumana’s FDA-approved low ejection fraction (LEF) ECG-AI algorithm, and HeartSciences’ MyoVista wavECGTM algorithm and MyoVista InsightsTM low ejection fraction algorithm (pending FDA approvals).
Meanwhile, Digital Stethoscope vendor Eko Health announced that its SENSORA AI-ECG platform has been issued Category III CPT Codes, effective from the 1st of July 2025. The SENSORA platform includes FDA-cleared AI algorithms to identify signs of structural heart murmurs, low ejection fraction (Low EF), and arrhythmias. SENSORA integrates with Eko’s CORE 500 Digital Stethoscope, which includes an imbedded 3-lead ECG sensor.
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Smart Cardia receives FDA approval for Outpatient Cardiac Telemetry for Its 7-Lead ECG Patch and Cloud Platform
The Mobile Cardiac Telemetry (MCT) market in the US is about to get more crowded with the news that Swiss-based SmartCardia has received FDA approval for its 7L patch to be used for Mobile Outpatient Cardiac Telemetry (OCT/MCT). SmartCardia had already received FDA clearance for Extended Holter, Event and Holter monitoring, meaning the vendor can now offer all four remote cardiac monitoring modalities from one device.
smartQare and Neways Electronics International NV announce strategic manufacturing partnership
Dutch remote patient monitoring device vendor smartQare, which was also featured in our October newsletter, announced a partnership with Neways Electronics, for the production, assembly, and packaging of its Healthdot 5 mobile continuous wearable sensor. Healthdot 5 was developed in partnership with Patient Monitoring market leader Philips and integrates directly with traditional hospital patient monitoring systems. The ability to continuously monitor patients throughout their hospital journey’s is becoming a priority for healthcare providers. With GE HealthCare, Mindray, and Masimo all having developed and released their own mobile continuous wearable devices, it appears Philips is now ready to enter the market, albeit with a strategic partnership.
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AliveCor now available to US Veterans
Personal ECG vendor AliveCor announced the activation of its services and solutions, designed specifically for the U.S. veterans. It has been approved for use by veterans specifically on the Veterans Affairs (VA) Federal Supply Schedule and Defense Logistics Agency (DLA) ECAT Contract System. Following the activation, veterans can now get prescriptions for AliveCor's KardiaMobile 6L, or its credit card-sized single-lead KardiaMobile personal ECG device, including two-years of KardiaCare membership.
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Fourth Frontier receives FDA approval for chest-worn Frontier X Plus device
The lines between consumer and medical devices continued to blur in November, with New York and Bangalore based company Fourth Frontier announcing that it had received FDA 510(k) approval for its chest-worn Frontier X Plus device. Following the approval, the company said it plans to partner with Independent Diagnostic Testing Facilities (IDTFs) and cardiac rehab centres to roll out the device to the US market.
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OmnySense Awarded US Patent on Smart-Thermometer with Integrated 3/6-Lead ECG
Adding to an ever wider variety of form factors and medical devices encompassing ECG sensors, Israeli company OmnySense has been awarded a US patent for its full 3/6-Lead ECG Smart Thermometer. To be able to provide an ECG reading without placing additional electrodes on the body, the Smart Thermometer’s metallic tip has been adapted to double up as an ECG electrode. This is used in combination with finger sensors on the device to provide a standard 3/6-lead trace.
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CardioComm integrates ECG technology with Sony mSafety Platform
Canadian remote cardiac monitoring company CardioComm has announced that its GEMS Mobile ECG Smartphone app will now be embedded into Sony’s mSafety Watch. The integration eliminates the need for a smartphone by allowing users to connect CardioComm’s HeartCheck CardiBeat ECG monitor via Bluetooth to the mSafety watch and record a 30-second ECG.
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Rapid Response Revival withdraws CellAED Automated External Defibrillator from UK market
In big news from the UK’s Automated External Defibrillator market, Australian company Rapid Response Revival withdrew their CellAED from the UK market. In the words of Signify Research’s Alfie Edwards, the device ‘offered something new to the market - a lightweight, low-cost, disposable defibrillator which was simple enough to be used by all…In my opinion, it was the first, and arguably only, personal defibrillator available in the UK market.’ Alfie offers his take on the story (including plenty of readers comments) here.
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