Clinical Care News Round-Up - October 2023

In this monthly news round up, I am providing 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. Cardiomatics gains MDR approval for AI-based platform

Earlier this month, Cardiomatics announced that it had received the first MDR approval for AI-based ECG interpretation. Its Cardiomatics v5 software offers detection and analysis of 21 heart abnormalities and disorders and now includes a new atrioventricular (AV) block detection of 2nd and 3rd degrees. Polish-based Cardiomatics originally received CE-marking in 2018, gaining the opportunity to become one of the first commercially available solutions of AI-based ECG analysis in Europe. It currently serves 200 clinics across 15 countries in Europe and has recently lodge a submission for FDA approval in the US. Its solution is device agnostic and able to be used on a wide range of acquisitional devices, including long-term ECG devices, the fastest growing segment within the ambulatory Diagnostic Cardiology market. This ability to interpret long-term ECG recordings and streamline the analytic process has given Cardiomatics a cutting edge over similar start-up companies also active within the use of AI in Diagnostic Cardiology ECG. Most crucial in a time where many cardiology practices are seeking solutions to reduce reading times and increase the number of patients that can be assessed. Gareth Jones also discusses additional developments that were announced at the recent Cardiology congresses in this insight here.

1. Philips launches new interop solution

The digital new age has bought with it the need for clinical care solutions that can interoperate with each other, enabling solutions to interact and share critical information to support safe and effective patient care. Since its acquisition of Capsule Technologies, Philips has been clearly beavering away to build on its data integration platform to enable interoperability between its solutions. Philips has subsequently announced the ability of its?Philips Capsule Medical Device Information Platform (MDIP)?to interoperate with?Philips Patient Information Center iX (PIC iX). The integration of the solutions will enable agnostic device integration into its central station monitor, to be able to assess and analyse patient information from a wide range of solutions. The new offering from Philips will overcome the challenges healthcare providers can face when utilising solutions from a number of different vendors. The capture and streaming of patient data in one system will provide a single source to enable a comprehensive overview of core patient information to help guide their treatment.?

1. New seed funding for post op – AI monitor

FluidAI has gained $15 million in Series A funding for its AI-based postoperative patient monitor designed to detect post-operative anastomotic leaks. The funding was led by SOSV?and?Graphene Ventures. The solution from FluidAI aims to detect leaks that can occur after surgery and can lead to serious complications, including sepsis or even death. With a clear trend to move patients out of the hospital sooner in their care pathway, the need for solutions to detect complications that can occur soon after surgery is further increasing. With its AI-based technology, the FluidAI solution uses advanced sensors to identify leaks earlier, improving clinical outcomes and reducing the need for further treatment. The funding will allow FluidAI to invest into additional R&D required to expand its solution to new regions and further develop the solution into other segments.

4.?????????????? Masimo gets FDA clearance for ORi?

Masimo has just announced that it has received De Novo 510k FDA clearance for the first and only FDA-Cleared non-invasive and continuous parameter to provide insight into hyperoxia under supplemental oxygen. Masimo subsequently demonstrated the product at the recent Anaesthesiology congress in San Francico, California. The ORiTM parameter utilises Masimo’s rainbow? Pulse CO-Oximetry platform for use in conjunction with oxygen saturation (SpO2) to provide increased resolution of changes in oxygenation under supplemental oxygen. The solution will enable clinicians to monitor and manage the oxygen levels of adults undergoing surgery in perioperative hospital environments. Traditionally, assessments of measuring hypoxia have been through blood tests to assess partial pressure of oxygen, or PaO2, which do not allow for continuous measurements. The ORi? technology has been available outside of the US since 2021, when it gained CE marking. The ORI parameter can be utilised with the Masimo Root platform?, Radical-7? and Rad-97? Pulse CO-Oximeter solutions. This new development from Masimo will further position the company as a leading provider of pulse oximetry solutions, with an advanced offering to further meet the demands of clinicians striving to improve patient care, by reducing costly adverse events.

1. Rumours have started as to who will buy Medtronic’s Respiratory and Monitoring business units

An article published by Reuters at the end of September suggested whispers of talks between Medtronic and Carlyle Group Inc., whereby Carlyle will purchase the Respiratory and Patient Monitoring lines from Medtronic. Medtronic announced in October 2022 that it intended to spin off its Monitoring and Respiratory Interventions business lines to enable the company to focus on strategic developments of its Medical surgical line. The product brands to be spun off into a new company included, amongst others, its Nellcor, Puritan Bennett, Shiley and McGrath product ranges, all well-known brands in the monitoring and respiratory space. It valued the business at $2.2 billion according to its 2022 financials. The rumoured talks with Carlyle have suggested that the purchase price of $7 billion is being considered. Carlyle Group Inc. is a Global investment firm which manages over $385 billion worth of assets across 3 business segments (global private equity, global credit and global investment solutions). It is an active investor in the health industry. Both currently, and in the recent past, it has a number of companies within its healthcare investment portfolio including CureApp which it invested into in 2022, Medline which it invested into in 2021 and OneMedical which it invested into in 2018 and subsequently divested to Amazon in 2022. If the deal is to happen, it is expected that the investment company will be in a strong position to invest in the strategic direction of the Monitoring and Respiratory Interventions business lines, providing its core brands the ability to regain share that it has seen fall in recent years.

1. GE publishes results from pilot study of its Portrait Solution in the ward

GE HealthCare was also busy at the recent Anaesthesiology congress, and had announced results of a pilot study it had conducted in partnership with the Cleveland Clinic, evaluating GE HealthCare’s Portrait Mobile wireless and wearable monitoring solution. The study nick-named COSMOS (Continuous Ward Monitoring with the GE HealthCare Portrait Mobile Monitoring Solution) assessed 100 post-surgical patients. In the study, the Portrait monitoring solution assessed the patient’s respiratory rate, oxygen saturation, and pulse rate. The COSMOS study used alarm burden analytic software to evaluate the interaction of physiologic data, duration of alarm delays and alarm thresholds to determine the potential number of alarms on Portrait Mobile per patient per day at various configurations. The alarm data collated can then be used for the optimization of ward default values and further enable refinement on an individual basis to improve usability.

As the Portrait solution is intended for continuous ward monitoring, the likelihood of over alarming in patient recovery is heightened due to the more frequent assessment of core patient vitals. Traditionally key vitals are taken every 4-6 hours, so the need to reduce over alarming when measurements are continuously assessed will be core in the success of the solution. Although the ability to detect patient deterioration is vastly improved, the possibility of alarms being ignored or silenced is much greater. The study has enabled GE HealthCare to set a baseline for its Portrait solution to reduce preventable patient harm from delayed recognition of clinical deterioration and help alleviate alarm burden.

The Portrait solution from GE HealthCare gained FDA approval in August 2023. Since then, GE HealthCare has been on its FlexAcuity? roadshow, demonstrating its Portrait and Canvas solutions across the United States. Its strategy is clearly to educate the clinicians on the benefits of these solutions in person and demonstrate the advantages of continuous ward monitoring to detect deterioration in high-risk patients earlier.

1. NHS delivers 10,000 virtual ward bed target

The NHS has announced that it has achieved its target to roll out 10,000 virtual ward beds by the end of September 2023. It claims to have treated more than 240,000 patients at home through the scheme, by establishing 10,421 virtual wards aimed at treating patients with long-term illnesses such as chronic obstructive pulmonary disease (COPD) and heart failure. The statement came just days after the UK Government announced it was investing ￡30 million to innovative technology to help alleviate the burden on the NHS. The funding is available to the ICSs within NHS England to enable the purchase of critical technology that can help tackle the waiting lists and speed up diagnosis. The investment follows the ￡200 million that was invested by the UK Government in the health service to improve access to healthcare in the coming months. As part of the Urgent and Emergency Care Recovery Plan, announced in January 2023, ￡1 billion was also committed by the UK Government to enable the NHS to deliver 5,000 additional permanent, fully staffed hospital beds, 10,000 virtual ward beds and 800 new ambulances. ￡21 million was also promised to invest into Artificial Intelligence (AI) based technologies to further improve patient diagnosis. It is clear that the government has identified the struggles of the NHS in the UK, and hopeful that the additional financial support will return the healthcare system back to the high standards expected.

Signify Research has published its update on the Patient Monitor market and Diagnostic Cardiology market. We also have the following new reports coming out in the next few months:

·??????? Infusion Pump available in November

·??????? AI in Diagnostic Cardiology ECG available in December

·??????? Fetal Monitors available in January

·??????? Hospital-At-Home – Patient Monitoring available in February

We welcome further conversations on the trends specifically impacting the market.

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