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Cranfield, UK, 2nd September 2024, Written by Gareth Jones –
Despite being peak holiday season in the many regions, August still proved to be a busy month across the Clinical Care market. Here are some of the major stories, plus our take on them, below.
- Zoll acquires Vyaire’s ventilator business in virtual auction for $37 million
One of the biggest news stories in the Clinical Care market during August was the announcement by Zoll Medical Corporation that it had acquired the ventilator business of Vyaire Medical in a virtual auction, for a reported $37 million. The auction was held as part of Vyaire’s Chapter 11 bankruptcy protection process, initiated in June this year, after it failed to refine debts built up during the Covid-driven boom and subsequent bust of the ventilator market. As part of its Chapter 11 process, Vyaire is also seeking a buyer for its respiratory diagnostics businesses. For Zoll, the acquisition marks a strategic expansion, extending its reach beyond the Transport & Emergency segment and into the Critical Care and Neonatal markets. Signify Research recently published the 2024 version of its Global Ventilator monitoring report providing a deep dive into the competitive developments in this dynamic market.
- Breas Medical undertakes nationwide U.S. correction of over 8,000 ventilators
In more news from the ventilator market, Swedish-based home mechanical ventilator vendor Breas Medical began a nationwide correction of 8,186 of its Vivo 45 LS ventilator devices in early August. The correction was in response to internal testing of the company’s Vivo 45 LS, a small, portable ventilator, which showed the potential for elevated levels of formaldehyde that could cause effects including reversible airway irritation or inflammation. The updates apply to devices manufactured from February 2021 to July 2024 and includes lowering the maximum room air temperature for use of the ventilators from 104 degrees Fahrenheit (40 degrees Celsius) to 86 F (30 C). it also requires all buyers of new devices to shipped up to July 2024 to run the ventilators for 14 days before using them on patients.
- Baxter divests its Vantive Kidney Care Segment to The Carlyle Group for $2.8 billion
In another big corporate action, Baxter International announced it had signed a definitive agreement under which Washington D.C.-based Carlyle Group will acquire Baxter’s Kidney Care segment, to be named Vantive, for $3.8 billion. The move is part of a larger restructuring process, first announced in April 2023, which involved the creation of four business units, and the spin-out of its kidney care business into a separate, publicly traded company. Baxter ultimately concluded that a sale of its kidney care business was in the best long-term interests of all concerned, allowing it to reduce debts and focus on its remaining core business units (Baxter also sold its BioPharma Solutions Business to private equity – Advent International and Warburg Pincus – for $4.25 billion in May 2023). Carlyle’s acquisition of Vantive has been made in partnership with Atmas Health, a specialist medtech-focused investment vehicle created by Carlyle and long-term healthcare executives in September 2022. Interestingly, at around the same time it had been reported that Carlyle had entered into exclusive negotiations to acquire majority stakes in Medtronic’s patient monitoring and respiratory interventions business.
- CMS publishes final notice for New Pathway for Breakthrough Device Reimbursement
In an important development in the regulatory arena, the Centers for Medicare & Medicaid Services (CMS) published a final notice describing the process and procedures for the Transitional Coverage for Emerging Technologies (TCET) pathway. The TCET pathway’s goal is to expedite the regulatory process for new technologies that could potentially benefit the Medicare population. The new TCET pathway aims to offer a more efficient and transparent Medicare coverage review process that allows for enhanced communications between industry and CMS, clear evidence requirements, and defined timelines for final coverage actions. Eligibility for the TCET pathway is limited to devices that are (1) designated by FDA as Breakthrough Devices; (2) determined to be within a Medicare benefit category; (3) not already the subject of an existing Medicare National coverage determination (NCD); and (4) not otherwise excluded from coverage through law or regulation. CMS anticipates accepting up to five TCET candidates per year, and for technologies accepted into and continuing in the TCET pathway, CMS’s goal is to finalize an NCD within six months after FDA market authorization.
- iRhythm launches remote cardiac monitoring services in Austria, the Netherlands, Switzerland, and Spain
On the eve of the 2024 European Cardiology Congress in London, iRhythm has announced the commercial launch of its Zio monitor and Zio long-term continuous (LTCM) ambulatory ECG monitoring service in Austria, the Netherlands, Spain, and Switzerland. The Zio monitor, and accompanying ZEUS (Zio ECG Utilization Software) system, had previously received CE Marking Under Medical Device Regulation (EU MDR) in December 2023. The Zio LTCM service provides up to 14 days of continuous, uninterrupted ECG monitoring. According to iRhythm, its Zio Monitor will begin shipping in the four countries in September, with widespread availability anticipated in 2025.
- American College of Cardiology (ACC) Releases Guide to Remote Patient Management
Reflecting the rise in use of remote monitoring devices to monitor and manage patients with a variety of cardiovascular conditions, the ACC published a new workbook remote patient management (RPM). The workbook provides guidance to the cardiovascular care team on definitions, types, clinical uses, benefits and limitations of RPM. The workbook also aims to help clinical practices determine whether they are ready for RPM utilization and provide considerations about how to set up an RPM program.
- PaceMate Acquires Medtronic Paceart Optima System
Remote cardiac monitoring solutions provider PaceMate acquired Medtronic’s Paceart Optima system, an on-premises cardiac workflow solution. According to Pacemate, the addition of Paceart Optima will ‘significantly’ expand its global footprint buy adding nearly 1,000 clinic locations worldwide. PaceMate, which reached 100,000 managed patients in April this year, is one of a number of vendor agnostic ambulatory cardiology service providers that has emerged in recent years.
- Masimo W1 Medical Watch Receives FDA 510(k) Clearance for Connectivity to the Masimo SafetyNet Telemonitoring System
Adding yet more functionality to its ever growing suite of Patient Monitoring solutions, Masimo announced that its Masimo W1 ® medical watch has received FDA 510(k) clearance for connectivity, allowing it to be integrated with the Masimo SafetyNet telemonitoring solution. Masimo W1 Medical received FDA clearance last year as the first medical watch to provide continuous oxygen saturation (SpO 2) and pulse rate (PR) for over-the-counter and prescription use at home and in hospitals. Integrations between W1 Medical and Masimo SafetyNet have already been undertaken in Europe and the Middle East. The integration of W1 Medical into Masimo SafetyNet adds to existing connections with Masimo’s tetherless fingertip pulse oximeter (Radius PPG), and continuous wireless thermometry (Radius T), in addition to a variety of spot check devices.
- New devices combining sleep and cardiovascular monitoring
As more evidence of the relationship between sleep disorders and cardiovascular health comes to light, monitoring solutions that address both conditions are becoming more common. This month, two vendors made significant announcements in this regard. First, Florida-based ReactDX announced the launch of its NiteWatch, an FDA-approved sleep-monitoring device that measures SpO2, Photoplethysmogram (PPG), pulse rate, airflow, respiratory effort, and heart rate variability (HRV). The collected data enables reporting for total sleep time, sleep stages, central sleep apnea index (CAI), and oxygen desaturation index (ODI). Subsequently, Atlanta-based start-up Huxley Medical announced FDA approval for its chest-worn, sleep apnea diagnostic patch, SANSA. Huxley claims the device, which measures eight physiological channels, is the first and only FDA-approved chest-worn patch that uses AI to detect sleep disordered breathing while simultaneously providing an ECG reference channel. Huxley Medical is a portfolio company of Georgia Tech’s Advanced Technology Development Centre.
- More AI-ECG developments
The AI-ECG ecosystem continues to expand, with news this month that Northern Ireland-based B-Secur and Texas-based FIRMINIQ had signed a strategic partnership to integrated B-Secur’s AI-based ECG algorithms into FIRMINIQ’s connected health solutions. FIRMINIQ specialises in software and app development for wearable and medical devices, RPM programmes, and cloud-to-cloud secure data sharing. Meanwhile, Slovakia-based AI ECG vendor Powerful Medical announced that its AI-powered PMCardio platform has been successfully rolled out at Jolimont Hospital, part of one of the largest hospital groups in Belgium.
- Google unveils Pixel Watch 3 with new health and fitness features
In the fast-moving wearables space, Google announced the release of its latest smartwatch, Pixel Watch 3, at its Made by Google event. In addition to parameters available on previous Pixel Watch versions, including sleep tracking, stress levels and vitals such as oxygen, skin temperature and heart rhythm, the new version includes what Google calls a first-of-its-kind loss of pulse detection. Loss of Pulse Detection on Pixel Watch 3 is an opt-in feature that has the ability to detect loss of pulse and automatically place a call to emergency services if the wearer is unresponsive.
- Natus Medical Incorporated launches AI-based EEG interpretation application, autoSCORE
In an exciting development for the EEG market, Neuro and Sensory technology vendor Natus Medical announced the commercial launch of autoSCORE, an AI-based EEG interpretation application developed by Holberg EEG, a spin-off company from the Haukeland University Hospital in Bergen, Norway. In related news, researchers at Mayo Clinic have recently published research which demonstrates how AI can be used to analyze electroencephalogram (EEG) tests more quickly and precisely, enabling neurologists to find early signs of dementia among data that typically go unexamined.
- ESC 2024
Finally, The European Society of Cardiology (ESC) 2024 Congress takes place in London from the 30th of August to the 2nd of September. Signify Research’s Senior Market Analyst Gareth Jones will be attending on Monday the 2nd of September and looks forward to meeting some of you there to discuss the latest developments in diagnostic cardiology.
Signify Research’s most recent reports include new analysis on the Diagnostic Cardiology, Patient Monitors, 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:
- Anaesthesia Devices available in August.
- High-End Patient Monitors available in December.
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 Gareth Jones
Gareth joined Signify Research in 2021 as Senior Market Analyst in the Digital Health team, where he covered emerging markets including Remote Patient Monitoring (RPM) and Ambulatory Diagnostic Cardiology. In 2023, Gareth joined Signify’s Clinical Care team where, his coverage areas include Diagnostic Cardiology and Patient Monitors.
About Sam Wilson
Sam Wilson joined Signify Research in 2023 as a Market Analyst within the Clinical Care team. He brings experience working as an Economist for the Intellectual Property Office, creating strategy reviews and impact evaluations, used to aid government trade negotiations. Sam holds a first-class bachelor’s degree in economics from Loughborough University, where modules included topical issues such as healthcare. Away from the office Sam enjoys staying active with dog walks, football and cricket, and his interest in volunteering took him on a charity visit to Ethiopia.
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
Signify Research provides healthtech market intelligence powered by data that you can trust. We blend insights collected from in-depth interviews with technology vendors and healthcare professionals with sales data reported to us by leading vendors to provide a complete and balanced view of the market trends. Our coverage areas are Medical Imaging, Clinical Care, Digital Health, Diagnostic and Lifesciences and Healthcare IT.
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