Bioserenity

Bioserenity is a French health technology company developing connected medical devices and AI-driven diagnostic tools, notably the Cardiologs ECG analysis platform, to improve remote patient monitoring and cardiac care.

Bioserenity is a French health technology company that develops connected medical devices and artificial intelligence-based diagnostic tools. The company focuses on remote patient monitoring and the analysis of physiological signals, particularly electrocardiograms (ECGs), to assist healthcare professionals in detecting and managing cardiac conditions. Its work sits at the intersection of medical device engineering, signal processing, and machine learning, aiming to make diagnostic-grade monitoring more accessible outside traditional hospital settings.

Founded in 2014 in Paris, Bioserenity emerged from a collaboration between engineers and clinicians who sought to address the limitations of conventional cardiac monitoring, such as short recording windows and the need for in-person visits. The company's flagship product, Cardiologs, is a cloud-based platform that uses deep learning algorithms to analyze continuous ECG data recorded by wearable devices. The platform is designed to identify arrhythmias, including atrial fibrillation, with a level of accuracy comparable to that of trained cardiologists, and it has received regulatory clearance in multiple jurisdictions.

History and Founding

Bioserenity was co-founded by Raphaël Souchier, Julien Wintz, and Antoine Fraysse, who combined expertise in biomedical engineering, software development, and clinical research. The company initially operated as a spin-off from research conducted at the École des Mines de Paris and the Institut de Recherche et Coordination Acoustique/Musique (IRCAM), where early work focused on advanced signal analysis. In 2015, Bioserenity launched its first wearable prototype, a patch-based ECG recorder that could stream data to a smartphone application.

The company raised its first significant funding round in 2016, securing €5 million from investors including BPI France and Idinvest Partners. This capital supported the development of the Cardiologs algorithm and the initiation of clinical validation studies. By 2018, Bioserenity had obtained CE marking for its ECG analysis software in Europe, and in 2019, the U.S. Food and Drug Administration (FDA) granted 510(k) clearance for the Cardiologs platform, allowing its use in American healthcare settings.

Technology and Products

Bioserenity's core technology is the Cardiologs ECG analysis engine, which employs a neural network architecture trained on a large dataset of annotated ECG recordings. The system processes single-lead and multi-lead ECG signals, detecting patterns associated with normal sinus rhythm, atrial fibrillation, atrial flutter, and other conduction abnormalities. The algorithm outputs a structured report that includes beat classification, rhythm analysis, and flagged anomalies, which clinicians can review through a web-based dashboard.

The company also develops the Bioserenity Patch, a wearable sensor that records ECG data for up to 14 days continuously. The patch is waterproof and designed for patient comfort, with adhesive electrodes that minimize skin irritation. Data from the patch is transmitted via Bluetooth to a companion mobile app, which then uploads encrypted information to the Cardiologs cloud service. This workflow enables long-term monitoring without requiring patients to maintain a diary or visit a clinic for data retrieval.

In addition to cardiac monitoring, Bioserenity has explored applications in neurology, particularly for the detection of epileptic seizures using electroencephalogram (EEG) signals. However, as of 2024, the EEG product line remains in research and development stages, with no commercial release announced.

Regulatory and Clinical Validation

The Cardiologs platform has undergone several clinical studies to validate its diagnostic performance. A notable multicenter trial published in 2020 reported that the algorithm achieved a sensitivity of 97.5% and specificity of 98.2% for detecting atrial fibrillation compared with expert cardiologist review. These results contributed to the FDA clearance and to recommendations from professional cardiology societies that mention AI-assisted ECG analysis as a supportive tool for screening.

Bioserenity has also pursued regulatory approvals in other markets. In 2021, the company received clearance from Japan's Pharmaceuticals and Medical Devices Agency (PMDA) for the Cardiologs software, and it has established partnerships with distributors in Southeast Asia and Latin America. The company maintains an ISO 13485 quality management system certification for its medical device development processes.

Business and Partnerships

Bioserenity operates as a business-to-business company, selling its platform to hospitals, cardiology clinics, and telemedicine providers. Its revenue model combines software subscription fees with hardware sales of the patch devices. In 2022, the company reported annual recurring revenue of €8 million, a figure that grew to €12 million by 2023, reflecting increased adoption in remote cardiac care programs.

The company has formed strategic alliances with major health systems, including a partnership with the Assistance Publique – Hôpitaux de Paris (AP-HP) to pilot remote monitoring for post-operative cardiac patients. Bioserenity also collaborates with academic research groups at Sorbonne University and Stanford University to refine its algorithms and explore new clinical use cases. In 2023, the company announced a collaboration with Samsung Electronics to integrate Cardiologs analysis into Samsung's health platform, enabling users of Galaxy smartwatches to receive AI-driven ECG interpretations directly on their devices.

Impact and Future Directions

The integration of AI into cardiac diagnostics has the potential to reduce the burden on specialist services and improve early detection of conditions like atrial fibrillation, which is a leading cause of stroke. Bioserenity's approach exemplifies the broader trend of digital health tools that shift monitoring from episodic, clinic-based encounters to continuous, patient-centered data collection. The company's success has also influenced the development of similar platforms by competitors, such as AliveCor and iRhythm Technologies.

Looking ahead, Bioserenity aims to expand its algorithm library to cover additional cardiac conditions, including heart failure and myocardial ischemia. The company is also investing in federated learning techniques to train models on distributed datasets without compromising patient privacy, a move that could facilitate multi-institutional research. As of 2024, Bioserenity employs approximately 80 people across its Paris headquarters and a satellite office in Boston, Massachusetts, and it continues to pursue funding for international expansion.