Femasys Inc. announced receiving 510(k) clearance from the FDA for its FemVue Controlled diagnostic device.
The device integrates features of FemVue and FemChec technologies for fallopian tube evaluation and workflow efficiency improvement.
This clearance marks a significant milestone in Femasys' commitment to practical, clinician-focused innovations.
FDA Clearance Achieved
Femasys received FDA clearance for the innovative FemVue Controlled device.
Integration of Technologies
The device combines features of the original FemVue and FemChec technologies into a single product.
Streamlined Manufacturing
The next-generation device simplifies manufacturing processes and practice workflows.
- The integration of multiple technologies into a single device enhances clinical utility and operational efficiency for healthcare providers.
- The FDA clearance signifies recognition of Femasys' commitment to advancing women's health through innovative diagnostic solutions.
Femasys' FemVue Controlled device represents a leap forward in diagnostic technology, offering a comprehensive solution for fallopian tube evaluation. The company's focus on simplifying care delivery and enhancing scalability underscores its dedication to improving women's healthcare globally.