Clinical Care Monthly Round-up - September 2024
Hello Clinical Care news junkies. Here is the team’s monthly round-up, featuring the most prominent news in the clinical care market for September.?
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If you feel we have missed something out don't hesitate to comment below!?
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Currently featuring news from Masimo , Comen , 飞利浦 , Senzime , 深圳迈瑞 , iRhythm Technologies, Inc. , BioIntelliSense, Inc , Astellas Pharma , Eko Health B-Secur , MEZOO , Roche Diagnostics Asia Pacific Respiree , 苹果 , Withings , Nihon Kohden America , European Society of Cardiology , The Emergency Services Show
?#signifyresearch?#clinicalcare #news??
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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. Masimo founder & CEO Joe Kiani resigns following bitter boardroom struggle??
One of the biggest stories in the clinical care market in September was the resignation of Masimo founder and CEO Joe Kiani, following the culmination of a bruising boardroom battle with activist investor Politan Capital Management. In a board meeting on the 19th of September, Masimo’s shareholders elected Politan candidates Darlene Solomon and Bill Jellison to the board rather than Kiani and Masimo nominee Christopher Chavez. Michelle Brennan, a current board member, was appointed interim CEO in the wake of Kiani's departure.?
The genesis of Politan’s proxy fight can be traced back to Masimo’s $1 billion acquisition of consumer electronics business Sound United in 2022, in which it saw an opportunity to expand the footprint of its medical-sensor technologies into Sound United’s customer-base. However, a precipitous fall in Masimo’s stock price and market capitalisation in the wake of the acquisition triggered Politan into action. Clearly, Masimo’s announcement that it planned to separate its consumer audio and health products business in March of this year was not enough to allay all the concerns raised by Politan Capital during its boardroom campaign. Concerns, it must be stressed, denied by Kiani and his supporters throughout the saga.?
Ironically, September also saw Masimo strike two deals with both Google and Qualcomm to develop reference platforms for original equipment manufacturers (OEMs) creating smart watches based on Google’s Wear OS platform. According to Masimo, OEMs choosing to adopt the new reference platform will be freed to up focus on designing and building the physical exterior and user interface, while the devices’ interiors, including Snapdragon wearable platforms and Masimo biosensors, will be designed, provided, and tested by Masimo.?
The ousting of Kiani as CEO has also led speculation of a possible thawing of relations with Apple, following a long-running and costly legal dispute between the two companies over the use of Masimo’s pulse oximetry technology in its?Series 9 and Ultra 2 smart watches. Whether there is any merit in this remains to be seen but given the rapidly evolving nature of the wearables market, it is unlikely we have heard the last of this.??
2. Comen launches new suite of Clinical Care solutions?
September saw Chinese Clinical Care Shenzhen Comen Medical Instruments Co., Ltd., announce the launch of a new range of Continuous Multiparameter, Fetal and Maternal, and Spot-Check Vital Signs monitors. Comen’s new Multiparameter monitors (ND 10, ND 12, ND 15) feature End-tidal carbon dioxide (ETCO2) and Cardiac Output parameters. According to Comen, their new ND range can detect more types of arrythmia (38) than any other Patient Monitor currently on the market. They also offer up to 72 hours of full disclosure review (compared to an industry standard of 48). Comen’s new NC6 and NC7 Vital Signs monitors allow for continual monitoring in general wards, have a range of customised workflow options for specific patient needs, and integration with hospital information systems and central monitoring systems to improve clinical workflow efficiencies. Finally, the company introduced two new fetal monitors, the CF5 and CF8. These devices emphasise patient and clinician flexibility, enhanced connectivity, and precision. Notable features include waterproof transducers and offline data storage, which underscore the growing importance of mobility and flexibility during the monitoring process during birth. Interestingly the new devices will have triplet capability. Many of the features listed above align with broader industry trends seen in our latest Clinical Care reports, Patient Monitors – World – 2024, and Fetal Monitors—World—2024.?
3. Philips launches new Patient Monitor Series??
Not to be outdone, Patient Monitors market leader Philips also announced the release of its new IntelliVue 6000 Series of Continuous Multiparameter monitors during September. In keeping with recent developments in the Patient Monitors market, the IntelliVue 6000 Series can be adapted to both low and high-acuity settings, giving providers greater flexibility with their resource allocation decisions. The new monitors are also compatible with Philips Microstream Co2 Nanopod and temperate prediction modules and can connect to the Measurement Rack 6000, allowing for integration with advanced monitoring modules including BIS and NMT.??
4. NMT Monitoring vendor Senzime secures new US contract?
In the neuromuscular monitoring (NMT) market, Swedish vendor Senzime announced that it had secured an initial purchasing contract with a hospital of a top 5 US-based Integrated Delivery Network (IDN) with strong presence on the US East Coast. The contract includes install and use of Senzime’s TetraGraph neuromuscular system in all its operating rooms. The company’s TetraGraph solution helps anaesthesiologists accurately determine the correct dose of paralytic drugs and their antagonists, and determines when patients have safely recovered post-surgery. Each year, approximately 100 million patients receive paralytic drugs during surgery, requiring precise monitoring to prevent severe postoperative complications. The recent 2023 US and European clinical guidelines recommend quantitative train-of-four neuromuscular monitoring for all patients receiving these neuromuscular blocking drugs. Signify Research has just commenced research on its High-End Patient Monitors & Consumables – World – 2024 report, which will assess the device and consumables markets for high-end monitoring parameters, including depth of sedation, NMT, Nociception, EEG, rSo2, and Advanced Hemodynamic Monitoring. If this is an area of interest to you, please reach out to Signify Research’s Senior Market Analyst Gareth Jones for more information.????
5. Mindray launches new Anaesthesia device??
Mindray unveiled its latest innovation, the A3 Anaesthesia Device, designed to meet the increasing demand for Non-Operating Room Anaesthesia (NORA). The device was showcased at the 'Association of Anaesthetists Annual Congress’ last week. The growth of Non-Operating Room Anaesthesia (NORA) is becoming an increasingly important trend in the anaesthesia device market. As hospitals perform more specialist procedures outside traditional operating rooms, NORA allows for lower-cost interventions without occupying OR space. While this trend may not significantly expand the overall market size, it is driving demand for mid-range and low-end devices, especially in emerging regions like India.?
6. iRhythm agrees licencing agreement with BioIntelliSense, gets regulatory nod in Japan??
September was another busy month for ambulatory cardiac monitoring vendor iRhythm. At the beginning of the month it announced that it had entered into a licensing agreement with BioIntelliSense to commercialise the latter’s patented pulse oximetry, accelerometry and trending non-invasive blood pressure technologies. One of the opportunities identified by iRhythm pursuant to the agreement is the potential to expand into the Sleep Apnea monitoring market. Signify Research highlighted two product launches in its last Clinical Care round-up that support the growing convergence of the Remote Cardiac and Sleep Apnea monitoring markets. The agreement also presents potential opportunities for iRhythm to leverage BioIntelliSense’ growing footprint in the US hospital-at-home (H@H) market, where Continuous ECG monitoring is being increasingly demanded from healthcare providers to supplement continuous vital sign monitoring. Following this, iRhythm also announced Japanese Regulatory Approval of the Zio ECG Monitoring System, and now intends to work towards a reimbursement decision for the Zio ECG monitoring system with the Japanese Ministry of Health, Labour, and Welfare (MHLW). With both Philips (BioTel) and iRhythm now established in the country, these are exciting times for the Japanese ambulatory cardiac monitoring market.??
7. Astellas Announces FDA Listing of DIGITIVA heart failure management solution??
In another example of the convergence of the diagnostic cardiology, digital health, and life sciences markets, Japanese life sciences company Astellas Pharma Inc. announced that its digital health solution for heart failure, DIGITIVA, has been listed with the US Food and Drug Administration (FDA). DIGITIVA, which has been classified as a Class I Software as a Medical Device (SaMD), is comprised of three components: Eko Health’s Core 500 Digital Stethoscope/3-lead ECG device, a patient app built on digital health company Welldoc’s AI-based platform, and a dedicated clinical review team. The DIGITIVA clinical review team triages patient data, including previously elusive biomarkers specific to heart failure, and notifies the patient’s treating physician when certain signals are present that may indicate the patient would benefit from intervention. Signify Research had previously covered this partnership in its report, AI in Diagnostic Cardiology ECG – World – 2023, a topical report looking at the major developments around AI for ECG interpretation.??
8. B-Secur receives FDA approval for AI-based HeartKey Rhythm Solution?
In another exciting development in the diagnostic cardiology market, Northern Ireland-based B-Secur, announced that its HeartKey Rhythm suite of ECG algorithms had received FDA approval. B-Secur’s HeartKey Rhythm differs to many other AI-ECG algorithms currently on the market in that its’ purpose is not diagnostic, but to improve signal quality of third-party ambulatory and consumer ECG devices. Given the plethora of devices currently on the market and in development, solutions such as B-Secur’s HeartJKey Rhythm will be critical if the additional ECG data generated can be put to meaningful use.??
9. Mezoo receives FDA approval for HiCardi+ H100 wearable ECG solution??
South Korean remote cardiac monitoring vendor Mezoo announced that it had received FDA approval for its?wearable ECG monitoring solution, HiCardi+ H100. The company claims this makes it the first South Korean vendor to receive FDA certification for a system incorporating real-time analysis algorithms within a wearable device. The news highlights the increasing importance of South Korean vendors in the remote cardiac monitoring market. Fellow South Korean vendor Wellysis, a spin-off from Samsung, had previously received FDA approval for its long-term ECG patch (S-Patch) in February 2024.??
10. Roche Diagnostics and Respiree partner to streamline in-hospital patient monitoring across APAC?
Also in the APAC region, life sciences company Roche Diagnostics has announced a collaboration with Singapore-based Respiree, the developer of a cardio-pulmonary wearable sensor and software platform that measures multiple biometrics, including pulse rate, oxygen saturation, respiratory rate, temperature, tidal depth, and inhalation-to-exhalation ratios. According to the two companies, by combining Respiree and Roche’s cobas pulse blood glucose monitoring solution, healthcare professionals will be able to register patients to Respiree's connected devices in real-time, monitor historical data and potential deterioration directly at the patient's bedside, without needing to return to workstations or medical carts. They will also be able to simultaneously measure vital signs and blood sugar and annotate clinical notes on the Respiree solution in the cobas pulse system.?
11. Apple introduces Sleep Apnea notifications to Apple Watch??
In another example of the increasing focus on sleep apnea monitoring, Apple unveiled a suite of new features for its Apple Watch and AirPods Pro 2, including Sleep Apnea notifications, based on a new Breathing Disturbances metric develop by the company. The sleep apnea notifications are expected to receive marketing authorisation from the Food and Drug Administration (FDA) and other global health authorities soon. It is expected it will be available this month in more than 150 countries and regions, including the US, the EU, and Japan. The Breathing Disturbances metric uses the Apple Watches built-in accelerometer to detect small movements at the wrist associated with interruptions to normal respiratory patterns during sleep. Every 30 days, Apple Watch will analyse breathing disturbance data and notify users if it shows consistent signs of moderate to severe sleep apnea so they can speak to their doctor about next steps, including potential diagnosis and treatment.?
12. Withings receives FDA approval for new contactless Sleep Apnea diagnostic device?
Another development in the Sleep Apnea monitoring market in September was announced by Withings, which received FDA approval for its Sleep Rx Mat. Sleep Rx requires a one-time set up and fits under any mattress, to provide analysis of sleep, breathing, and cardiovascular activity throughout the night. The device is available in the US by prescription as part of clinical sleep management or remote patient monitoring (RPM) programmes. Sleep Rx uses a pneumatic sensor to measure respiratory rate, body movement, and continuous heart rate, along with tracking sleep cycles, duration, and interruptions. Sound and motion sensors detect snoring and breathing disturbances, key indicators of Sleep Apnea. Each morning, Sleep Rx provides a sleep quality score, giving patients an easy-to-understand assessment of their sleep patterns.?
13. Nihon Kohden acquires intracranial electrode vendor Ad-Tech Medical??
Japanese Patient Monitors vendor Nihon Kohden announced that it will be acquiring 71.4% of the shares of NeuroAdvanced Corp, the parent comp any of Adtech Medical Instrument Corporation. Ad-Tech designs and manufactures intracranial electrodes such as depth electrodes and subdural electrodes, which are used for surgical treatment of drug-resistant epilepsy. The acquisition will complement Nihon Kohden’s portfolio of EEG monitoring devices. The company also expects that the expansion of its consumable portfolio will lead to a stable and consistent revenue base and growth.??
14. Signify Research at ESC Congress and the Emergency Services Show??
At the beginning of the month, Signify Research’s Senior Market Analyst Gareth Jones attended the 2024 European Society of Cardiology Congress in London. Some of the key trends observed in London included the introduction of new clinical guidelines for Atrial Fibrillation, with more emphasis on patient education and the impact of comorbidities, much discussion and presentations on the use of AI for ECG interpretation, and continuing innovation in the ambulatory cardiology market. Read Gareth’s ESC 2024 show report here.?????
Towards the end September, Signify Research Director Kelly Patrick and Market Analyst Alfie Edwards attended The Emergency Services Show in Birmingham. The show highlighted the competition traditional Advanced Life Support vendors are facing from a cohort of new market entrants. The exhibits at the show highlighted the growing importance of associated IT software solutions, the need for easy-to-use and flexible solutions, and how value-based-care is influencing purchasing decisions and business models. Signify Research will be publishing a new report on the global Advanced Life Support Solutions market in February 2025. If you have an interest in this important topic, reach out to Alfie without delay!??
Signify Research’s most recent reports include new analysis on the Diagnostic Cardiology, Ventilators, Fetal Monitors, AI in Diagnostic cardiology and Hospital-At-Home markets. We also have several new reports just published or publishing soon:?
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We welcome further conversations on the trends specifically impacting the markets highlighted.?
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