Clinical Care News Round Up - July 2024

In this monthly news roundup, the team has summarised some of the latest news and developments impacting the clinical care markets that caught our attention in recent weeks, including our thoughts on the implications for the market.

1.???? AliveCor release InstantQT in Europe, receives CPT Codes of new Kardia 12L solution

Personal ECG vendor AliveCor has had a particularly newsworthy July. Following on from the commercial release of its Kardia 12L ECG System in June, the company announced that the American Medical Association (AMA) had granted new Category III CPT codes for Kardia 12L. Signify Research’s Senior Market Analyst Gareth Jones has penned an insight piece unpacking what this means for the broader Diagnostic Cardiology market here. ?

During July AliveCor also announced the roll-out of its InstantQT? solution in Europe. InstantQT allows physicians to remotely record a point-of-care ECG to support antipsychotic prescribing decisions. Many prescribed pharmaceuticals, such as antipsychotic medications and some cancer treatments, are associated with QT interval prolongation, where the heart’s electrical system takes longer than normal to recharge between beats. For this reason, clinicians are required to send patients for an ECG before prescribing these treatments or changing doses, a time-consuming process. InstantQT now cuts out this middle-step, allowing for near instant prescriptions supported by ECG data.

Finally, sports fans may have noticed the news that Alun Wyn Jones, the world’s most-capped rugby union player, has partnered with AliveCor to launch its ‘Let’s Talk Rhythm’ campaign to raise awareness of atrial fibrillation (AFib). The former captain of Wales and the British and Irish Lions captain was diagnosed with AFib towards the end of his career.

2.???? Octagos Health secures $43m investment to advance its AI-based remote cardiac monitoring solutions

Remote Cardiac monitoring software vendor Octagos health announced a $43 million Series B investment round. The funding was managed by Morgan Stanley Expansion Capital with continued participation from Mucker Capital and other strategic investors. The company’s AI-driven platform offers continuous monitoring and data analysis for patients with a wide range of cardiac devices, including pacemakers, defibrillators, ambulatory monitors, consumer wearables, and other modalities. The platform also integrates with more than 70 EHR platforms and allows for customisable report features.

3.???? AI-ECG vendor acquires NVIDIA DGX H100 systems

Spanish AI-ECG vendor Idoven announced that it had acquired NVIDIA DGX H100 systems to accelerate its AI algorithm training and validation processes. Spanish multinational telecoms company Telefónica, also an investor in Idoven through its corporate venture capital arm Wayra, has been selected as a key partner to provide expertise in equipment provision, housing, and maintenance. Idoven expects this new computation architecture will enable the company to process multiple ECGs simultaneously, reducing processing times and ensuring quicker patient responses.

4.???? Samsung announces new Galaxy Ring, Galaxy Watch 7, and Galaxy Watch Ultra

In the wearables space, Samsung Electronics announced the new Galaxy Ring, Galaxy Watch7, and Galaxy Watch Ultra as the latest additions to its wearables portfolio. The Galaxy Ring, Samsung’s first health ring, provides 24/7 monitoring, tracking and personalised insights, including analysis of heart health, sleep patterns, cycle tracking and one's Energy Score.?It includes three sensors that measure sleep, activity, and heart rate data. The company’s new Galaxy Ultra Watch includes sensors for blood oxygen levels, sleep quality, stress levels and heart rate.?

5.???? SOMNOmedics introduces new product for anaesthesia depth monitoring

Germany MedTech manufacturer SOMNOmedics AG announced the release of a new anaesthesia depth monitoring device. The NARCOguide, expans its product range for sleep diagnostics, neurology and cardiology to include another area - anaesthesiology. The new NARCOguide combines anaesthesia depth determination with the patented method of continuous, non-invasive blood pressure measurement. This, claims SOMNOmedics, makes it the only EEG-based anaesthesia depth monitor on the market that can continuously map the hemodynamic effects during general anaesthesia in addition to the central effects. Signify Research will be assessing solutions such as these in its upcoming report, High-End Patient Monitors & Consumables – World – 2024, due for publication in December 2024.

6.???? Guidehealth Teams With Story Health to Bring Health Systems a Value-based Cardiology Care Program

Continuing the recent theme of cardiology-specific value-based-care (VBC) programme development, California-based Story Health a cardiology-focused digital health company announced a strategic deal with Guidehealth, an AI-enabled healthcare services company. Story Health offers telehealth, health coaches, AI, and connected devices to support patients with heart conditions like heart failure, hypertension, and arrhythmias. Following the partnership, Health systems and CINs partnered with Guidehealth can integrate Story Health’s program to support at-risk patients with heart conditions like heart failure, hypertension, and arrhythmias.

7.???? Regulatory approvals for Kardi AI and FibriCheck

In more news from the fast-changing remote cardiac monitoring market, Czech-based AI ECG vendor Kardi AI announced that it has received MDR IIa approval for its AI-based Kardi AI Service. The service combines the company’s proprietary ECG recorder, Polar H10, and AI-ECG analysis algorithms to diagnose a range of arrhythmias. In related news, FibriCheck announced the FDA approval of its smart-phone based arrythmia detection app, AI-based algorithms, and healthcare provider portal. Based on PPG-sensors, FibriCheck states that it is the only smartphone application using PPG-technology that is FDA-cleared with equivalence to ECG.?

8.???? Bon Secours Mercy Health and Philips sign multi-year strategic Patient Monitoring collaboration

In another sign of the long-term shifts taking place in the Patient Monitors market, market leader Philips announced a multi-year patient monitoring partnership with Bon Secours Mercy Health (BSMH), one of the USA’s largest Catholic health systems. The partnership will provide access to the latest Philips monitoring innovations, including a scalable patient monitoring platform that integrates patient data and provides vital insights. It will standardise patient monitoring for BSMH’s 49 hospitals. Philips claims that the partnership will lead to reduced costs through a predictable payment model and enabling further reinvestment in innovation. Signify Research recently published the 2024 edition of its global Patient Monitors report. This insight piece gives a high-level insight into some of the key trends taking place in the market.

9.???? Masimo announces Sleep Halo?, Advanced Sleep Analysis for the Masimo W1?

Irvine, CA-based Masimo, has been in the news for a variety of reasons of late, continues to bring new products and features to market. In July it announced that its Masimo W1 Sport wearable device will be upgraded to include its sleep analysis product, Sleep Halo?. Sleep Halo uses continuous Masimo pulse oximetry and machine learning to provide insights into the quality of an individual’s sleep, including overall timing, duration of sleep stages, periods of rest and wakefulness, and episodes of desaturation. The nightly sleep analysis, based on an algorithmic calculation, will be visualised on the companion Masimo Health smartphone app. Signify Research’s Digital Health Premium Insights service has previously written about Masimo’s ongoing legal disputes with Apple. Access the story with a free, no-obligation 30-day trial, here.

10.? TytoCare receives FDA clearance for AI Lung Crackle Detection

Virtual care company TytoCare recently announced that it had received an additional FDA clearance for a new AI-powered diagnostic capability, Tyto Insights for Crackle Detection. Tyto Insights for Crackle Detection is designed to help clinicians detect lung crackles in adults and children over two years old that may need attention during a virtual clinic visit. This latest feature joins TytoCare’s existing suite of diagnostic tools, including Tyto Insights for Wheeze Detection, which was cleared by the FDA in 2023. Last month TytoCare had announced a major software update to its Home Smart Clinic, increasing its integrations with multiple healthcare provider types, more seamless sharing of patient data, and enhanced patient engagement and onboarding features.

11.? Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability (HTI-2) Proposed Rule

The Office of the National Coordinator for Health Information Technology (ONC) which is part of the U.S. Department of Health and Human Services (HHS) has announced that is has proposed the new HTI-2 rule. The HTI-2 rule has been designed to further progress towards data interoperability throughout healthcare by improving the access, exchange, and use of data. According to the announcement, the new rule will expand the certification and use of API technology based on HL7’s Fast Healthcare Interoperability Resources (FHIR?) standard for additional uses cases across the health care sector. This will be specifically focused in the following areas:

???????? Electronic Prior Authorization

???????? Access to Billing and Payment Transactions

???????? Public Health Exchange

The rule also provides additional information on rules and exceptions for information blocking, updates to the criteria for encrypt authentication credentials. Additionally new criterion is also provided for administrative” APIs, and for a standardised FHIR?-based API for public health reporting. The ONC will be providing briefing sessions in the coming weeks to provide further details on the proposed rules in the core areas. The intention of the rules are to help break down the silo barriers between healthcare delivery providers and provider organisations, to help with more streamlined data sharing. By conforming to the new standards, the ONC hopes it will enable a healthcare delivery system that can be truly interoperable and have the ability to support standardised data.

12.? GE HealthCare and AWS announce strategic collaboration to accelerate healthcare transformation with Generative AI

GE HealthCare recently announced that it had formed a strategic collaboration with Amazon Web Services (AWS) to utilise AWS’ Bedrock cloud managed service to establish and deploy bespoke generative AI applications. The collaboration will be utilised to spearhead its development of Generative AI tools to help in the delivery of precision diagnosis. GE HealthCare claims that the delivery of its innovations will help to ‘streamline healthcare operations, increase diagnostic and screening accuracy, enhance outcomes, lower access hurdles, and promote equitable care, thereby easing provider workload and accelerating industry innovation.’ Although it is likely that the tools developed will initially be focused on the imaging sector, its expansion into other areas of healthcare will be likely in the future as it further develops tools to optimise efficiency.

13.??????????? Ventilator glitches for Hamilton Medical and Baxter

Hamilton Medical has provided a notification to update the software on a number of its C6 ventilators. A current glitch has reportedly affected its C6 ventilators that utilise versions v1.1.4, v1.1.5 and v1.1.6 of its software. The ventilator may fail to restart ventilation if it enters sensor fail mode after open suction is performed and the patient is reconnected. The company has issued instructions to users if the issue is to occur and has recommended immediate update to its software to avoid adverse health consequences.

Similarly, Baxter Healthcare has recalled its Life2000 Ventilator with a battery dongle (product code MS01-0118) from sale in the US. The ventilator is not charged appropriately if there is damage to the battery dongle resulting in the patient being unable to use the ventilator. If users have observed any damage to the battery or that the ventilator isn’t charging correctly, they can replace it immediately. All other functioning products will be relaced in due course to reduce the risk of battery malfunction in the near term.

Signify Research’s most recent reports include new analysis on the Diagnostic Cardiology, Ventilators, Infusion Pumps, Fetal Monitors, AI in Diagnostic cardiology and Hospital-At-Home markets. We also have several new reports just published or publishing soon:

·??????? Patient Monitors just published!

·??????? Anaesthesia Devices available in August.

·??????? High-End Patient Monitors available in December.

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We welcome further conversations on the trends specifically impacting the markets highlighted.

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