Clinical Care News Round Up - 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. BD Acquires Critical Care Group from Edwards LifeSciences

Arguably the biggest announcement this month is that from BD on its intention to acquire the Critical Care group from Edwards LifeSciences. The $4.2 billion deal will result in the addition of Edwards advanced patient monitor solutions, including their haemodynamic monitoring solutions and smart AI algorithms to further expand BD’s connected care portfolio. The decision to add haemodynamic monitoring solutions alongside its existing infusion solutions will enable BD to expand its offering to the critical care and operating room care settings. As mentioned in Signify Research’s insight, BD had battled for several years to achieve its 510k approval for its flagship Alaris infusion system, which it subsequently obtained in July 2023. The solution was first recalled in 2020 due to a number of issues reported with the system including software and programming malfunction. However, due to its extensive installed base, BD managed to maintain it dominating position of the North American infusion pumps market in Signify Research’s infusion analysis released late last year, obtaining nearly a quarter of the market revenues in 2022. Edwards LifeSciences continues to dominate the haemodynamic monitoring market, with its gold-standard Swan Ganz pulmonary artery catheter, minimally invasive sensors, non-invasive cuffs, tissue oximetry sensors and monitors. It accounts to approximately 90% of the invasive blood monitor market. Edwards initially expanded its presence in haemodynamic monitoring through its acquisition of CAS Medical Systems, Inc in April 2019. Edwards’ strategy had been focusing on smartifying their solutions through development of advanced algorithms. The solutions offer predictive analytics to enable patient insight to reduce adverse events before they happen. The collaboration will enable BD to now compete head to head in more comprehensive deals with fellow infusion vendors ICU Medical and Baxter, which although falling slightly short on BD’s dominance in the infusion market, both have existing haemodynamic monitoring platforms within their portfolios. It is no doubt that these vendors will be closely assessing the upcoming developments from BD now that they have invested beyond their current infusion solutions and have greater opportunity to win larger bundle deals.

2. ResMed Acquires InHealthcare

UK based InHealthcare announced earlier this month that it had been acquired by ResMed. Founded in 2012, InHealthcare specialises in remote patient monitoring and virtual wards, currently supporting over 4 million patients in the UK. It offers a range of at home services ranging from chronic pain, COPD, heart failure in addition to home care monitoring. The acquisition will enable InHealthcare to further expand its offering by upscaling its remote patient monitoring platform both in the UK and overseas. ResMed is a significant player in the home sleep and respiratory care business also with a comprehensive remote monitoring platform. The acquisition will enable both companies to expand their service offerings, scale operations and extend their impact on patient care throughout the UK. Ultimately, InHealthcare’s future success will be dictated by the extent to which the?UK’s virtual wards programme expands in the medium-term. Signify Research’s Editor Mark Lazell discusses a deeper analysis into the acquisition in his recently published SPI.

3. Philips Publishes the Future Health Index 2024 Report

Philips has released its 2024 edition of the Future Health Index report. In its executive summary, it highlights the need to ‘bridge the gap’ in three key areas including, the workforce crisis, meaningful data and sustainability. Calling on insights from over 3000 healthcare leaders across 14 countries, the report highlights the need to rethink the way in which healthcare is delivered. With a vast healthcare shortage and increasing demands from an aging population the movement toward new care delivery models and AI enabled innovation is inevitable to enable a sustainable future. The report delves into the three key areas in more detail, providing insights into core considerations for each. Some of the key highlights included:

·??????? 77% of leaders report care delays due to staff shortages

·??????? 92% believe automating repetitive tasks is crucial for addressing staff shortage

·??????? 94% of healthcare leaders say their organisation experiences at least one data integration challenge that impacts its ability to provide timely, high-quality care

·??????? 85% say their organisation is currently or planning to invest in generative AI technologies

·??????? 86% of healthcare leaders believe that reducing CO2 emissions and the environmental impact of healthcare should be a top priority for healthcare organisations

4. Vyaire Medical Files for Chapter 11 Protection

Another blow to the ventilator market was announced earlier in the month, with Vyaire Medical filing for Chapter 11 protection. The company claims that it saw a significant decline in demand following the surges seen at the height of the COVID-19 pandemic. The application for Chapter 11 protection will enable the company to explore their options whist seeking a buyer. Vyaire now joins a growing list of vendors exiting the market, claiming profitability issues as the reason for exit.

Sam Wilson has just published Signify Research Ltd.’s most recent report on the ventilator market. His recent insight highlighted the trends seen in the market, including the shakeup in competitive environment.

5. Mindray Achieves UL Solutions Cybersecurity Assurance Program (CAP) certification

The North American arm of Mindray has been able to achieve UL Solutions Cybersecurity Assurance Program (CAP) certification to UL 2900-2-1 for its BeneVision N12, N15, and N17 monitors. It is the first China-based vendor to achieve the status. The UL 2900-2-1 certification process involved the rigorous assessment of products that connect to networks to ensure their safety and security. The certification demonstrated that Mindray exceeds the industry-standard cybersecurity measures. With the certification, Mindray is able to claim that its N12, N15 and N17 patient monitoring solutions will be able to be used safely within the providers own healthcare cybersecurity system.

6.? Fukuda Denshi’s Latest ECG and Data Management Systems Boast Breakthrough Technology

Fukuda Denshi announced the launch of its synthesized 18-lead function FX-9800 Resting ECG, designed for use in emergency rooms (ERs) and postoperative intensive care units (ICUs). FX-9800 will allow clinicians to detect signs of Acute Coronary Syndrome (ACS) that would have been overlooked in standard Resting ECG devices, giving Fukuda Denshi a broader solutions portfolio to offer its end-customers. Also in June, Fukuda Denshi announced the release of its EFS-1000 ECG Management System. EFS-1000 has been developed with scalable architecture, allowing for flexible deployments in a variety of health systems. It integrates with existing third-party ECG management solutions and hospital information systems.

Gareth Jones has just published Signify Research’ most recent update to the Diagnostic Cardiology market report. Gareth assesses the developments both in the traditional ECG market in addition to the fast expanding ambulatory segment. He also discusses some of the major trends impacting the market in his insight.

7. Additional Diagnostic Cardiology Developments in June:

a)???? Tempus Receives U.S. FDA 510(k) Clearance for Tempus ECG-AF, an AI-based Algorithm that Identifies Patients at Increased Risk of AFib

Tempus AI, Inc. has announced it has received 510(k) clearance from FDA for its Tempus ECG-AF device that uses AI to help identify patients who may be at increased risk of atrial fibrillation/flutter (AF). According to Tempus this is the ‘first FDA clearance for an AF indication in the category known as “cardiovascular machine learning-based notification software” and paves the way for physicians to use this innovative algorithm in the care of their patients.’

b)??? Anumana and InfoBionic.Ai Announce Collaboration to Advance AI-powered Remote Cardiac Telemetry Technology for Early Detection of Cardiac Diseases

Anumana and InfoBionic AI have announced that they have entered a joint -collaboration to develop and commercialise the next generation of remote cardiac care solutions. The collaboration will combine Anumana’s breakthrough ECG-AI? technology and InfoBionic.Ai’s MoMe ARC? platform. The development will further enhance the ability for InfoBionic.Ai’s MoMe ARC Platform’s ability to detect cardiac diseases earlier in the remote patient monitoring setting, with the potential to improve patient outcomes.

c)???? AliveCor Announces Dual FDA Clearance of AI Technology That Delivers 35 Cardiac Determinations and First-of-its-Kind Kardia 12L ECG System

AliveCor has announced that it has received 510k approval for its?KAI? 12L AI technology and the Kardia? 12L ECG System. The FDA approval enables AliveCor to claim that it is the world's first AI solution that can detect life-threatening cardiac conditions, including heart attacks, using a reduced lead set. The Kardia 12L ECG System, features the world's first AI-powered handheld 12-lead electrocardiogram (ECG) system with a unique single-cable design. It is capable of detecting 35 cardiac determinations (14 arrhythmias and 21 morphologies), including serious conditions like acute myocardial infarction (MI) and the most common types of cardiac ischemia.

d)??? Medicalgorithmics Receives FDA Approval for Commercialisation of New Arrhythmia Diagnostics Platform in the USA

Medicalgorithmics has also claimed it has gained FDA approval for its DeepRhythm Platform (DRP) is a cloud-based platform which incorporates its new generation of DeepRhythmAI (DRAI) artificial intelligence algorithms, providing high diagnostic efficiency and flexibility, allowing the analysis of data from various types of ECG solutions for arrhythmia diagnostics. The FDA approval follows the company’s CE marking for the solution gained earlier in the year, enabling the company to expand into both the US and European markets.

e)???? Philips Introduces New Cardiac Workstation

Philips has also made the announcement that it has launched its Cardiac Workstation in the EMEA region. Cardiac Workstation provides enhanced clinical decision support and workflow features and can interoperate with multiple enterprise systems and electronic health records (EHRs). Philips claims that the solution utilises sophisticated algorithms to speed collection and processing of ECG data, helping streamline care and prioritise at-risk patients.

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

·???????Diagnostic Cardiology just published!

·???????Patient Monitors available in July.

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

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

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