VISION
Wellvii’s vision is to enable the delivery of healthcare at any address through it’s all in one comprehensive, clinically accurate, connected healthcare solution that measures 9 vital signs from the finger, including the clinically accurate non-invasive blood pressure (NIBP) from the finger without calibration. By enabling healthcare in the home, the Wellvii platform empowers patients and caregivers with the health stats needed to drive better clinical outcomes and create a healthier patient population.
Quality Management System
The backbone of the company’s quality system is our ISO 13485:2016 certification. The standard operating procedures and documentation are reviewed during the company’s annual audit by TUV SUD America. By following the stringent guidelines of the ISO 13485 standard, Wellvii maintains compliance with the FDA and EU MDD medical device design, manufacture, and distribution guidelines through 2028 (after which the company will be MDR compliant).
Cybersecurity and HIPPA / GDPR
Wellvii is committed to cybersecurity and ensuring the protection of patient information and privacy through HIPAA HiTrust certification planned for in 2024. Wellvii works with qualified cybersecurity firms to perform security gap assessments, penetration testing, and vulnerability analysis of the Wellvii IT architecture.
Leadership Team
Board of Advisors
Dr. Stephen K. Klasko, MBA
Former CEO, Jefferson Health
Uwe Diegel
Former CEO, iHealth Europe
Prof. Dr. Andreas Pfützner CEO
PSHI (Mainz, Deutschland)
Our Partners
Avnet is a key strategic investor and board member since 2019, and provider of engineering, technology, and part procurement services.
Wellvii utilizes Care Daily’s AI Cloud platform to drive predictive analytics of vital sign and remote monitoring data.
Press Release
Wellvii and Care Daily Partner for Health at Home
ARC Devices Obtains $5 Million in Funding, Fueling Accelerated Launch of Breakthrough Products (accesswire.com)
Wellvii and Simzo Partner for Wellvii Temp Non-Contact Thermometer
Wellvii Inc has achieved FDA Clearance of the VitalDetect for blood pressure from the finger to replace the arm cuff. The VitalDetect measures 9 vital signs in 2 minutes.