Clinical Care News Round Up - October 2024

There was enough Clinical Care news for at least two newsletters in October! We’ve tried to collate the most relevant below:

• Ceribell IPO raises $207 million
• Zoll Medical completes acquisition of Vyaire’s ventilator business
• 91Life acquires Ambucor from Berkshire Hathaway
• New product launches from Senzime, Withings Health Solutions, Skylabs, and Dozee
• Masimo Radius VSM deployed at Vanderbilt University Medical Center
• First iRhythm Zio ambulatory ECG service patient order exchange over Epic’s Aura platform
• BBraun integrates smart infusion pumps with hospital EHR in the Netherlands
• Integration partnerships announced between Tenovi and Nonin, Mesi and tomedo, Wellvii and Be-Secur, CardioSignal and Heart Center M?lholm
• New AI-ECG regulatory approvals for Medicalgorithmics, AccurKardia, Carelog
• EEG-related regulatory approvals for Natus Medical, Epitel
• BioIntelliSense FDA approval for its BioButton Multi-Patient Wearable and BioDashboard System.
• Regulatory approvals for SmartQare (Thailand) and Byteflies (EU) for mobile continuous monitoring devices

Featuring news from American Society of Anesthesiologists? , European Society of Anaesthesiology and Intensive Care , Ceribell │ AI-Powered Point-of-Care EEG , ZOLL Medical Corporation , Vyaire Medical , 91Life , Senzime , Withings Health Solutions , Sky Labs Inc. , Dozee , 乐普（北京）医疗器械股份有限公司 , Masimo , iRhythm Technologies, Inc. , B. Braun China , Tenovi , Nonin Medical, Inc. , MESI , tomedo? , Wellvii Inc , B-Secur , Story Health , CardioSignal by Precordior , Zenicor Medical Systems AB , Medicalgorithmics S.A. , AccurKardia , Carelog , Natus Neuro , Epitel , BioIntelliSense, Inc , smartQare , Byteflies

M&A, restructuring, funding

• In a comparatively rare MedTech listing on public markets, Ceribell , the developer of an AI-powered point-of-care electroencephalography (EEG) platform for patients in emergency departments (ED) and intensive care units (ICU), announced the closing of its Initial Public Offering on the Nasdaq Global Select Market. The IPO raised approximately $207.3 million.
• Zoll Medical successfully completed the purchase of Vyaire Medical’s Ventilator business lines, including the Bellavista, LTV, 3100 HFOV and Fabian. ZOLL’s expanded offerings signify a strategic enhancement across several specialised ventilator markets. With the introduction of the Bellavista 1000 and Bellavista Neo, ZOLL positions itself strongly in both high-end and neonatal ventilator markets, catering to advanced care requirements. The addition of the LTV ventilator line strengthens ZOLL's capabilities in transport and emergency ventilation, further complementing the company’s existing EMV+ and Z Vent product lines and broadening its scope in critical mobile care. Additionally, the inclusion of the Fabian and 3100 HFOV ventilators, alongside the Bellavista Neo, significantly extends ZOLL’s reach and expertise in neonatal care, underscoring a commitment to supporting patients across a comprehensive range of ventilation needs. Signify Research will provide deeper insight into the competitive landscape in our upcoming Ventilator – World – 2025 report, due to be published in May 2025.
• 91Life , a cardiac monitoring and analysis software platform vendor, acquired Ambucor from Marmon Holdings , Inc., a division of Berkshire Hathaway. Ambucor is a remote cardiac monitoring services vendor, comprising a team of inhouse cardiac device monitoring and read-over specialists, and a proprietary vendor agnostic software platform.

Product launches & upgrades

• Senzime , a Swedish NMT vendor, announced the launch of its next-generation TetraGraph System at ANESTHESIOLOGY 2024 , which took place in the US city of Philadelphia. The new Tetragraph system includes a suite of new algorithms, automated workflows, and upgrades to its user interface. Following this, the company announced the first European hospital order for its new Tetragraph System. The NMT monitoring market has been significantly boosted by clinical recommendations, issued in late 2022, from both the American Society of Anesthesiologists and the European Society of Anaesthesiology and Intensive Care.
• Withings Health Solutions , a division of Withings, announced the launch of its BPM Pro 2, a cellular BP monitor and heart rate monitor. Pending FDA approval, BPM Pro 2 will also have a single-ECG capability. The device also allows for the sharing of patient reported outcomes for additional insight into each measurement, such as symptoms, medication adherence, sleep patterns, and screening questionnaires.
• Skylabs , a South Korean Medtech-start-up, unveiled an all-in-one wearable device that adds oxygen saturation, body temperature, and respiratory rate measurement functions to its existing smart ring, ‘Cart BP’. The new device will also have an improved battery-life over the existing Cart BP ring. Launched at HIMMS24 APAC, Skylabs said that the new product has been designed for in-hospital monitoring and adds to a growing number of in-hospital mobile continuous monitoring solutions on the market (e.g., GE Healthcare’s Portrait Mobile, Masimo’s Radius VSM, or mWear from Mindray).
• Also in the APAC region, Indian vendor Dozee used the occasion of its 9th birthday to announce the release of its new VS in-hospital patient monitoring solution. The device connects wirelessly to Dozee’s Ballistocardiography-based monitoring sensor sheet, which fits under a patient’s mattress and captures Heart Rate, Respiration Rate, Non-Contact Blood Pressure and Heart Rate Variability. VS can also integrate with Dozee and third-party BP cuffs, ECG patches, and Sp02 sensors.
• Lepu Medical announced upgrades to its AIView V10/V12 Cardiac Care Monitor (continuous multiparameter monitor), including the addition of the GCS (Glasgow Coma Scale) function, more remote viewing options for clinicians, and additional alarm management features.

Partnerships, integrations & new contracts

• Nashville, Tennessee-based Vanderbilt University Medical Center announced that it is piloting the use of Masimo’s Radius VSM patient-worn vital signs monitor with Masimo Patient SafetyNet supplemental remote monitoring in its Emergency Department (ED) and non-traditional care spaces. As part of the pilot, Radius VSM has been used on hallway beds, in the emergency medical service offload area, and on patients in the waiting room who are typically only monitored periodically.
• In what could be a significant indicator of the shifts underway in the remote cardiac monitoring market, iRhythm announced the first Zio ambulatory ECG service patient order exchange over Epic’s Aura platform, at Baptist Health System KY & IN.
• In Netherlands, Rotterdam’s Maasstad Hospital announced that it had started connecting 900 B Braun Spaceplus smart infusion pumps to its Electronic Health Record (EHR), meaning the automatic collection of all information about medication and fluids administered to patients. B Braun is part of a group of predominantly European MedTech vendors driving increased interoperability through the service-oriented device connectivity (SDC) standard.
• Tenovi , a remote patient monitoring (RPM) data and automation platform, announced a strategic partnership with Nonin , a developer of pulse oximeters, regional oximeters, and capnographs. Under the partnership, Nonin’s Bluetooth enabled Model 3230 finger pulse oximeter?will be added to the list of devices available on Tenovi’s RPM integration platform.
• Mesi , a Slovenian developer of a modular spot-check vital sign-monitoring solution, announced the integration of its Mesi mTablet with tomedo , one of the leading practice management software for MacOS vendors in Germany, Austria and Switzerland.
• Northern-Ireland-based AI-ECG vendor B-Secur continuous to grow its partnership base. This month, the company announced a collaboration with Wellvii Inc ., the developers of a FDA-cleared finger-based BP device, to integrate its AI-ECH software into Wellvii BP Go, to create an at-home BP/ECG combination device.
• Cardiology-focused Value-Based-Care (VBC) vendor Story Health announced a partnership with Kettering Health, which will give its patients, who opt in to the programme, access to virtual, personalised care through medication management, home heart health monitoring, and clinical care team support. The VBC market is covered in depth by Signify Research’s Digital Health team. This insight by Signify Research’s Hamir Harbham summaries some of the key trends from his latest global report on the VBC market. ?
• In Denmark, CardioSignal , the developer of a mobile-based application for detecting Atrial Fibrillation (AFib), announced a collaboration with one of the country’s leading private hospitals (Heart Center M?lholm) for the home monitoring of post-ablation patients. Under the agreement, patients who have undergone an ablation procedure at M?lholm will have 12 months of complementary access to the CardioSignal smartphone application.
• Staying in Scandinavia, Swedish remote monitoring vendor Zenicor was awarded an ECG with interpretation service contract with the Dalarna Region. Zenicor stated the contract will run for two years, with an opportunity for extension to four years. The upper ceiling of the contract value was stated at just under $1 million.

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Regulatory approvals

• iRhythm announced FDA 510(k) Clearance for design updates previously made to its Zio AT Device. The clearance is the first of two that iRhythm has applied for in relation to ongoing remediation efforts with the FDA, following a warning letter issued by the agency in May 2023.
• Polish AI-ECG vendor Medicalgorithmics announced that its new generation of DeepRhythmAI (DRAI) artificial intelligence algorithms has obtained Health Canada registration for use in Canada. Medicalgorithmics’ cloud-based platform, DeepRhythm Platform (DRP), is also under review by Health Canada.
• Meanwhile, fellow AI-ECG vendor AccurKardia announced that it had received FDA Breakthrough Device Designation (BDD) for its AI-ECG-based Aortic Valve Stenosis (AVS) algorithm. AVS is a structural heart condition that frequently occurs in elderly patients and is typically identified via bedside examination and auscultation, with definitive diagnosis via echocardiography.
• Another AI-ECG-related FDA BDD was awarded to Carelog , for its algorithm that detects diastolic dysfunction, often an underdiagnosed precursor to heart failure with preserved ejection fraction (HFpEF). As with AVS, diastolic dysfunction is typically diagnosed with far more costly technologies such as echocardiography.
• Natus Medical , a US-based EEG vendor, received FDA 510(k) approval for its Grass MR Conditional/CT Cup Electrodes. The new electrodes, US FDA-cleared for 1.5T and 3T MR environments, feature 28% longer leads and have been designed to allow for simple preparation for safe and quick transitions from?electroencephalogram ?(EEG) testing to magnetic resonance imaging (MRI) scans. Also in October, Natus announced that it had submitted an FDA 510(k) premarket notification?for its Natus point-of-care EEG device.
• Fellow US-based EEG vendor Epitel announced the fourth FDA 510(k) approval for its REMI Vigilenz Bedside Notifications, which conducts an automated analysis of EEG data collected by the REMI wireless wearable EEG System in near real-time. Notifications occur when the algorithm recognizes seizure characteristics within a section of EEG.
• Fresh from its recently inked partnership with remote cardiac monitoring vendor iRhythm, BioIntelliSense announced FDA approval for its BioButton Multi-Patient Wearable and BioDashboard System. The new solution offers a reusable inpatient solution for automating vital sign collection across medical surgical units, specialty care areas, emergency departments. It also features data-driven exception management allowing for more personalised trending notifications for each patient.
• Netherlands-based SmartQare announced that its mobile continuous monitoring device, viQtor, had received regulatory approval in Thailand. In April this year, SmartQare established a strategic partnership with Philips, to integrate viQtor into Philips patient monitoring platform.
• Byteflies , a Belgian RPM device and platform vendor, announced it had received CE Certification under the EU’s MDR for its Byteflies Kit Model 2, a mobile monitoring device that can record ECG, EEG, HR, EMG, and EOG signals.

Finally, Signify Research’s Clinical Care team have published the following insights this month:

• Healthcare Innovation Spotlight: Key Product Launches in Fetal Monitoring, Anaesthesia, and Ventilation
• Coverage of the UK Anaesthesia and Critical Care (ACC) Conference
• An infographic on the Anaesthesia Devices Market

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

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

• Infusion Pumps ?available in December.
• High-Acuity Patient Monitors & Consumables? available in January.
• Advanced Life Support Solutions available in February

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