When Bodily Data Enables Individualised Diagnostics
Since 2011, VivoSensMedical has been developing sensor-based diagnostic solutions for the continuous measurement of core body temperature. Using the innovative method of cyclofertilography, applied through the medical device system known as OvulaRing, the company aims to make cycle diagnostics more reliable and more individualised – supported by structural guidance from leap:up.
In clinical practice, cycle diagnostics often rely on isolated measurements – for example, single blood values, occasional temperature readings, or ultrasound examinations. These methods provide reliable snapshots but capture only a fraction of the underlying hormonal dynamics. Fluctuations within the cycle, individual rhythms or irregular patterns frequently remain undetected. For women with a desire to conceive, irregular cycles or hormonal disorders, this can mean that findings are only of limited diagnostic value.
The Leipzig-based company VivoSensMedical addresses precisely this diagnostic gap: it is not the methods themselves that are unreliable, but rather their temporal limitations. What matters is continuous data collection that can be used in everyday life, making cycle-relevant changes visible over time and providing a more precise foundation for medical assessments.
A Diagnostic System Consisting of Sensor, App and Medical Software
This principle forms the basis of cyclofertilography, a method for continuously analysing core body temperature using the three-part OvulaRing diagnostic system: a sensor ring for continuous data capture, an app for data transfer, and medical software for evaluation. The ring itself – comparable in size to common intravaginal medical products but without any hormonal function – measures core body temperature at short intervals, recording up to 288 data points per day. It is CE-certified and classified as a Class IIa medical device (according to the European Medical Device Regulation, MDR). The associated app is classified as a Class I medical device and acts as the interface for data transmission. The software, a medical product regulated as MDR Class IIb, forms the analytical core of the system. It stores and analyses temperature data and uses a reference database containing more than 65,000 documented cycles from around 10,000 users – according to the company, the largest continuous temperature database of its kind worldwide.
“Based on this foundation, the algorithms developed by VivoSensMedical recognise individual patterns in each user’s cycle and enable real-time assessment of fertility and cycle dynamics – without relying on standardised average models,” explains Sebastian Alexander, CEO of VivoSensMedical. “This approach differs fundamentally from classical diagnostic procedures, which often rely on standardised cycle assumptions and therefore capture individual deviations only to a limited extent. Cyclofertilography with OvulaRing, by contrast, enables analysis based on the actual temporal progression: hormonal rhythms, cycle shifts or irregular patterns become visible not through generalised reference values but through continuously recorded data series. This results in a differentiated picture of cycle-related processes that cannot be achieved through single measurement points or through a theoretical ‘standard cycle’. The entire diagnostic system is approved as a medical device and is already in regular clinical use,” Alexander continues.
A Position Between Established Diagnostic Markets
VivoSensMedical operates between two established fields: classical medical diagnostics and the consumer wearable market. While diagnostic procedures used in medical practice offer high accuracy, they remain isolated and time-limited. Wearables, by contrast, generate continuous data but are rarely clinically validated and only partially suitable for medical decision-making. “OvulaRing occupies an intermediate position: it captures data continuously like a wearable, yet is regulated as a medical device, thereby providing a basis that can be used both in everyday life and in clinical assessment. The technology closes a gap between clinical diagnostics and self-tracked health data. This approach is becoming increasingly relevant as reproductive medicine and women’s health demand methods that reveal individual patterns without requiring invasive or time-consuming clinical appointments,” Alexander notes.
VivoSensMedical was founded in 2011 as a spin-off from the Department of Gynaecology at Universitätsklinikum Leipzig (Leipzig University Hospital), following more than 25 years of research on cycle-dependent core body temperature. The project evolved as a classic translational development: from clinical observation to technical implementation and finally to a market-ready medical product. Serial production and market entry of the OvulaRing system followed as early as 2012.
In parallel, the temperature-based algorithms were further developed, clinical validation studies conducted and patent protection expanded, resulting in an internationally secured technology portfolio. Funding for these development stages was provided through EU programmes, government support and private investment. With increasing use by consumers and clinical partners, demands on quality assurance and production processes also grew. As a result, VivoSensMedical gradually transitioned from a research-driven start-up into a regulated medical technology company whose products can be used both in everyday life and in clinical contexts.
As the company scaled, VivoSensMedical faced the challenge of structuring internal processes to ensure compliance with regulatory requirements and enable future growth. A central focus of the collaboration with leap:up (a Saxony-based consultancy specialising in organisational development and regulatory structuring for technology-driven companies) lay in the regulatory and organisational development of the company. This included aligning the quality management system with the requirements of DIN EN ISO 13485 (the relevant European and international standard for quality management in medical device manufacturing) and structuring development and production processes to ensure both content and documentation comply with medical technology regulations.
In parallel, responsibilities between research, production, regulatory affairs and customer support were clarified in order to support the transition from a development-oriented organisation to a regulated serial-production company. Beyond regulatory issues, leap:up also assisted in identifying and securing suitable funding programmes and in establishing connections to regional and national networks. “This guidance helps us embed our technological, regulatory and organisational developments into a solid framework that now enables further growth,” Alexander explains.
OvulaRing forms the technological foundation of a diagnostic platform that reaches far beyond cycle observation. VivoSensMedical is now working to apply the continuous temperature measurement of cyclofertilography to chronobiological questions, such as analysing individual biorhythms or supporting cycle-oriented therapeutic decisions. Additional indications are being explored, including hormonal imbalance, premenstrual syndrome (PMS), cycle-oriented training or certain autoimmune conditions. “In the longer term, we aim to establish Europe’s first telemedical fertility centre, in which continuous temperature data, clinical assessment and digital support are integrated. Our goal is diagnostics that do not depend on isolated appointments but are grounded in individual data patterns over time and can be used both in everyday life and in medical care,” Alexander concludes.