Voluntis Announces FDA Clearance of Oleena, First Class II Software-as-a-Medical Device for Pan-Cancer Symptom Management

Recently, VCBeat (WeChat ID: vcbeat) learned from foreign media reports that French medical software development company Voluntis announced that its digital health software, Oleena, has received FDA approval for market launch. This digital tool helps cancer patients achieve self-management.

Voluntis, founded in 2001 and headquartered in Paris, France, is a medical software development company. The company is dedicated to developing digital health technologies to improve the quality of healthcare services and reduce medical costs. Voluntis was listed on Euronext in May 2018 under the stock ticker symbol VTX.

Voluntis developed Oleena based on its proprietary digital oncology therapeutics platform, Teraxium Oncology. The solution is designed to combine patient self-management with remote medical monitoring, serving cancer patients undergoing radiochemotherapy, tumor immunotherapy, and targeted tumor therapy.

Oleena is the first FDA-approved Class II Software-as-a-Medical Device (SaMD) indicated for multiple cancer indications. The software records patients’ clinical symptoms and disease progression in real time, while providing self-management guidance for common treatment-related side effects such as diarrhea, pain, nausea, and vomiting. Additionally, Oleena transmits recorded data to healthcare institutions, enabling physicians to conduct remote monitoring and clinical assessment. The information provided by the software helps hospitals assess patients’ physical conditions and promptly adjust treatment plans, thereby delivering efficient and timely medical support to patients.

Voluntis’s leadership believes that helping patients achieve self-management can reduce unexpected events such as treatment interruptions, thereby improving overall treatment outcomes. Oleena, a therapy tool based on communication technology, enables patients to control complex symptoms associated with the treatment process, allowing them to play an active role in self-management. Meanwhile, the remote monitoring capabilities of digital health tools will also help alleviate the burden on clinicians.

In addition, Voluntis has developed other digital health tools for remote diabetes monitoring, such as Insulia and Diabeo, to help patients better manage their symptoms and provide users with insulin dosing recommendations.

Pierre Leurent, CEO of Voluntis, stated, “Beyond monitoring patient symptoms, we believe that digital and personalized therapeutic interventions can help patients improve their condition in a timely manner while reducing costs for clinical healthcare services. We are delighted to launch Oleena to cancer patients worldwide; this innovative digital health software for oncology will revolutionize traditional cancer treatment methods.”

Dr. Arvind Dasari, an oncology expert at The University of Texas MD Anderson Cancer Center (UT MD Anderson Cancer Center), stated, “Voluntis’s digital therapeutic solution, powered by the Oleena platform, enables patients to achieve self-management through simple language and intuitive systems, while facilitating proactive intervention in their condition. This is undoubtedly a significant milestone in the field of oncology treatment.”

(Compiled by Xu Xiaoxue)