CB Scientific Inc. (CBSC) Formally Launches Next Generation MyCardia AT Cardiac Monitor
CB Scientific Inc. (CBSC) has officially launched its next generation MyCardia AT cardiac monitor in partnership with contract manufacturer Datrix, This FDA-cleared device is designed for the company's international distribution network in SE Asia, Hong Kong, and Macau.
The MyCardia AT offers an improved patient monitoring experience with its lightweight, easy-to-wear design and flexible options to transmit event recordings via iOS or Android smartphones using the MyCardia app. The device helps physicians detect cardiac arrhythmias in patients with intermittent symptoms during a 30-day monitoring period, addressing a critical health concern as ischemic heart disease deaths have increased from 2.7 million to 9.1 million since 2000.
CBSC is strategically enhancing its cardiac monitoring portfolio by integrating the device with its existing AWS Cloud-based MyCardia portal and smartphone applications. Distributors in Malaysia, Singapore, Thailand, Indonesia, Hong Kong, and Macau will begin registering the device with regulatory agencies, with plans to expand to China and Canada pending regulatory approvals.
CB Scientific Inc. (CBSC) ha ufficialmente lanciato la sua nuova generazione di monitor cardiaco MyCardia AT in collaborazione con il produttore a contratto Datrix. Questo dispositivo, approvato dalla FDA, è progettato per la rete di distribuzione internazionale dell'azienda nel sud-est asiatico, a Hong Kong e a Macao.
Il MyCardia AT offre un'esperienza di monitoraggio del paziente migliorata grazie al suo design leggero e facile da indossare, con opzioni flessibili per trasmettere le registrazioni degli eventi tramite smartphone iOS o Android utilizzando l'app MyCardia. Il dispositivo aiuta i medici a rilevare le aritmie cardiache nei pazienti con sintomi intermittenti durante un periodo di monitoraggio di 30 giorni, affrontando una preoccupazione sanitaria critica poiché i decessi per malattia ischemica del cuore sono aumentati da 2,7 milioni a 9,1 milioni dal 2000.
CBSC sta migliorando strategicamente il suo portafoglio di monitoraggio cardiaco integrando il dispositivo con il suo portale MyCardia basato su AWS Cloud e le applicazioni per smartphone esistenti. I distributori in Malesia, Singapore, Thailandia, Indonesia, Hong Kong e Macao inizieranno a registrare il dispositivo presso le agenzie regolatorie, con piani di espansione in Cina e Canada in attesa di approvazioni normative.
CB Scientific Inc. (CBSC) ha lanzado oficialmente su próxima generación de monitor cardíaco MyCardia AT en asociación con el fabricante por contrato Datrix. Este dispositivo, aprobado por la FDA, está diseñado para la red de distribución internacional de la empresa en el sudeste asiático, Hong Kong y Macao.
El MyCardia AT ofrece una experiencia mejorada de monitoreo del paciente con su diseño ligero y fácil de usar, así como opciones flexibles para transmitir grabaciones de eventos a través de smartphones iOS o Android utilizando la aplicación MyCardia. El dispositivo ayuda a los médicos a detectar arritmias cardíacas en pacientes con síntomas intermitentes durante un período de monitoreo de 30 días, abordando una preocupación de salud crítica, ya que las muertes por enfermedad cardíaca isquémica han aumentado de 2.7 millones a 9.1 millones desde el 2000.
CBSC está mejorando estratégicamente su cartera de monitoreo cardíaco al integrar el dispositivo con su portal MyCardia basado en la nube de AWS y las aplicaciones para smartphones existentes. Los distribuidores en Malasia, Singapur, Tailandia, Indonesia, Hong Kong y Macao comenzarán a registrar el dispositivo ante las agencias regulatorias, con planes de expansión a China y Canadá pendientes de aprobaciones regulatorias.
CB Scientific Inc. (CBSC)는 계약 제조업체 Datrix와 협력하여 차세대 MyCardia AT 심장 모니터를 공식 출시했습니다. 이 FDA 승인 장치는 동남아시아, 홍콩 및 마카오의 국제 유통 네트워크를 위해 설계되었습니다.
MyCardia AT는 가볍고 착용하기 쉬운 디자인과 iOS 또는 Android 스마트폰을 통해 MyCardia 앱을 사용하여 이벤트 기록을 전송할 수 있는 유연한 옵션으로 환자 모니터링 경험을 개선합니다. 이 장치는 의사가 30일 모니터링 기간 동안 간헐적인 증상을 보이는 환자의 심장 부정맥을 감지하는 데 도움을 주며, 2000년 이후 허혈성 심장병으로 인한 사망자가 270만 명에서 910만 명으로 증가한 중요한 건강 문제를 다룹니다.
CBSC는 AWS 클라우드 기반 MyCardia 포털 및 기존 스마트폰 애플리케이션과 장치를 통합하여 심장 모니터링 포트폴리오를 전략적으로 강화하고 있습니다. 말레이시아, 싱가포르, 태국, 인도네시아, 홍콩 및 마카오의 유통업체들은 규제 기관에 장치를 등록하기 시작할 것이며, 중국 및 캐나다로의 확장 계획은 규제 승인을 기다리고 있습니다.
CB Scientific Inc. (CBSC) a officiellement lancé sa prochaine génération de moniteur cardiaque MyCardia AT en partenariat avec le fabricant sous contrat Datrix. Cet appareil, approuvé par la FDA, est conçu pour le réseau de distribution international de l'entreprise en Asie du Sud-Est, à Hong Kong et à Macao.
Le MyCardia AT offre une expérience de surveillance des patients améliorée grâce à son design léger et facile à porter, ainsi qu'à des options flexibles pour transmettre les enregistrements d'événements via des smartphones iOS ou Android en utilisant l'application MyCardia. L'appareil aide les médecins à détecter les arythmies cardiaques chez les patients présentant des symptômes intermittents pendant une période de surveillance de 30 jours, abordant un problème de santé critique, car les décès dus à des maladies cardiaques ischémiques ont augmenté de 2,7 millions à 9,1 millions depuis 2000.
CBSC renforce stratégiquement son portefeuille de surveillance cardiaque en intégrant l'appareil à son portail MyCardia basé sur le cloud AWS et à ses applications pour smartphones existantes. Les distributeurs en Malaisie, à Singapour, en Thaïlande, en Indonésie, à Hong Kong et à Macao commenceront à enregistrer l'appareil auprès des agences réglementaires, avec des plans d'expansion vers la Chine et le Canada en attente d'approbations réglementaires.
CB Scientific Inc. (CBSC) hat offiziell die nächste Generation des MyCardia AT Herzmonitors in Partnerschaft mit dem Auftragshersteller Datrix auf den Markt gebracht. Dieses von der FDA zugelassene Gerät ist für das internationale Vertriebsnetz des Unternehmens in Südostasien, Hongkong und Macao konzipiert.
Der MyCardia AT bietet ein verbessertes Patientenmonitoring-Erlebnis mit seinem leichten, tragbaren Design und flexiblen Optionen zur Übertragung von Ereignisaufzeichnungen über iOS- oder Android-Smartphones mit der MyCardia-App. Das Gerät hilft Ärzten, Herzrhythmusstörungen bei Patienten mit intermittierenden Symptomen während eines 30-tägigen Überwachungszeitraums zu erkennen und adressiert ein kritisches Gesundheitsproblem, da die Todesfälle durch ischämische Herzkrankheit seit 2000 von 2,7 Millionen auf 9,1 Millionen gestiegen sind.
CBSC verbessert strategisch sein Portfolio für Herzmonitoring, indem das Gerät in das bestehende AWS-Cloud-basierte MyCardia-Portal und die Smartphone-Anwendungen integriert wird. Distributoren in Malaysia, Singapur, Thailand, Indonesien, Hongkong und Macao werden beginnen, das Gerät bei den Regulierungsbehörden zu registrieren, mit Plänen zur Expansion nach China und Kanada, die von regulatorischen Genehmigungen abhängen.
- FDA-cleared MyCardia AT cardiac monitor launched for international markets
- Device integrates with existing AWS Cloud-based MyCardia portal and smartphone apps
- Established distribution network in SE Asia, Hong Kong, and Macau
- Expansion plans for China and Canada markets in progress
- Addresses growing cardiac disease market (ischemic heart disease deaths increased from 2.7M to 9.1M since 2000)
- Pending regulatory approvals required before sales can begin in target markets
- Additional regulatory hurdles with China's NMPA still ahead
- No immediate revenue impact until regulatory approvals are secured
LAS VEGAS, NV / ACCESS Newswire / February 25, 2025 / CB Scientific, Inc. (OTC PINK:CBSC) ("CBSC" or the "Company"), a designer, manufacturer and distributor of non-invasive ambulatory cardiac monitoring products, announced today that the Company, in partnership with its contract manufacturer Datrix, LLC, is launching its next generation MyCardia AT cardiac event monitor targeted for use with our international distribution network in SE Asia, Hong Kong, and Macau. The newly branded MyCardia AT device is FDA-cleared and is designed to provide an improved patient remote cardiac monitoring experience with its lightweight, easy-to-wear design, including flexible and convenient options to transmit event recordings over an iOS or Android smartphone and utilizing our MyCardia Apple, Google or WeChat app.
The MyCardia AT cardiac event monitor helps physicians detect, identify, and diagnose potential cardiac arrhythmias in patients with intermittent transient symptoms closer to the time that they occur up to a 30-day monitoring period. Early detection and treatment of cardiac rhythm disorders helps to significantly reduce the burden of cardiac disease which can damage the heart and may even lead to an increased risk of stroke and death. According to the World Health Organization, since 2000 the largest increase in deaths is from ischemic heart disease which multiplied from 2.7 million to 9.1 million, and in 2021 accounted for
The Company is strategically enhancing its remote cardiac monitoring portfolio with the launch of the MyCardia AT device. This initiative aims to leverage the strength of our established brand name to drive recognition, streamline our product ecosystem, and reinforce our market presence. The MyCardia AT marketing strategy involves seamlessly integrating with our existing AWS Cloud-based MyCardia portal and the widely adopted MyCardia iOS and Android smartphone applications, with the goal of ensuring a cohesive and optimized user experience on a global scale.
Our established distributors in Malaysia, Singapore, Thailand, Indonesia, Hong Kong, and Macau will now begin registering the MyCardia AT device with their respective regulatory agencies for import approval. Upon completion, the MyCardia AT device will begin shipping at that time and be widely available throughout these respective markets going forward. Additionally next step regulatory submission work will immediately resume for the MyCardia AT towards the approval of our representative Chinese manufacturing partner Shenzhen Pump. The Company will also continue working directly with representatives from the National Medical Products Administration (NMPA) in China towards the completion of clearance to market approval for our device into that market. Regulatory submission will also begin with our Canadian distributor Your Heart Protector Corp. towards clearance to market acceptance throughout Canada.
As additional new developments occur, CB Scientific, Inc. plans to make timely announcements through press releases and regulatory filings to keep its shareholders, industry participants, and the public markets informed.
About CB Scientific, Inc.
CB Scientific, Inc., through its international subsidiaries, provides innovative products and services in the ambulatory non-invasive cardiac monitoring space. Our electrocardiogram (EKG) devices, interactive cloud-based acquisition software, and smartphone apps for both iOS and Android platforms provide improved compliance for patients at risk of abnormal heart rhythms, as well as more accurate information for physicians.
Company Contact Information:
Telephone: (888) 225-0870
Email: General Inquiries: info@cbscientificinc.com
Investor Inquiries: investor@cbscientificinc.com
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This information disclosure may contain forward-looking statements covered within the meaning of the Private Securities Litigation Act of 1995. These forward-looking statements relate to, among other things, plans and timing for the introduction or enhancement of our services and products, statements about future market conditions, supply and demand conditions, and other expectations, intentions, and plans contained in this press release that are not historical fact and involve risks and uncertainties. Our expectations regarding future revenues depend upon our ability to develop and supply products and services that we may not produce today and that meet defined specifications. When used in this press release, the words "plan," "expect," "believe," and similar expressions generally identify forward-looking statements. These statements reflect our current expectations. They are subject to a number of risks and uncertainties, including, but not limited to, changes in technology and changes in pervasive markets. This release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 27E of the Securities Act of 1934. Statements contained in this release that are not historical facts may be deemed to be forward-looking statements. Investors are cautioned that forward-looking statements are inherently uncertain. Actual performance and results may differ materially from that projected or suggested herein due to certain risks and uncertainties, including, without limitation, the ability to obtain financing and regulatory and shareholder approval for anticipated actions.
SOURCE: CB Scientific, Inc.
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