VOLUNTIS ANNOUNCES MARKET AUTHORIZATION FOR OLEENA, FIRST DIGITAL THERAPEUTIC IN ONCOLOGY
[caption id="attachment_9277" align="aligncenter" width="747"] Press Release[/caption]
Voluntis (Euronext Paris, Ticker: VTX - ISIN: FR0004183960), a leader in digital therapeutics, today announced it has successfully completed a U.S. Food and Drug Administration (FDA) regulatory review of its Oleena? software for oncology-related symptoms management and remote patient monitoring. Oleena? is determined as Class II medical device falling under enforcement discretion per FDA Guidance.
With an estimated 1.7 million new cases of cancer diagnosed every year in the United States, cancer management is one of the country?s leading health expenditure. Patients with cancer often experience distressing symptoms that impair daily functioning and quality of life. When manageable symptoms are left untreated or undertreated, they can lead to treatment interruptions, unscheduled ER visits and hospitalizations. New approaches based on the combination of self-management and remote monitoring have the potential to enhance the quality of care in oncology, improve clinical outcomes and reduce costs for health systems.
Oleena? is a unique solution in cancer care:
- Innovative digital approach with embedded clinical algorithms
- Patient self-management of cancer symptoms with actionable recommendations
- Combined with remote patient monitoring and care team supervision