[City, State] – [01-11-2023] – OUI Medical Inc., a leader in innovative medical device development, proudly announces the successful completion of its first-in-human testing for the P-Scope, its flagship product. This milestone marks a significant step toward bringing this revolutionary medical device to market. Concurrently, the company has submitted its application for Breakthrough Device Designation to the U.S. Food and Drug Administration (FDA).
The completion of first-in-human testing represents a critical achievement in OUI Medical’s journey. The P-Scope, designed for examining the abdominal cavity under local anesthesia in an outpatient setting, has demonstrated promising results in terms of safety, efficacy, and patient comfort. This testing phase is pivotal in ensuring that the device meets all regulatory standards for patient safety and efficacy.
Dr. Adarsh M Patil, the founder of OUI Medical, shared his enthusiasm: “The successful completion of our first-in-human trials brings us one step closer to transforming the landscape of abdominal examinations. The insights gained from these tests are invaluable in our quest to ensure the P-Scope is not only innovative but also safe and effective for patients.”
In addition to this significant achievement, OUI Medical has submitted its Breakthrough Device Designation application to the FDA. This submission is an important step in the regulatory process, potentially expediting the review and approval of the P-Scope. The Breakthrough Device Program aims to provide patients and healthcare providers with more timely access to medical devices that provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions.
The P-Scope is poised to offer a more efficient, less invasive, and cost-effective alternative to traditional abdominal examination methods. Its innovative design and advanced technology address the growing need for improved diagnostic tools in healthcare.
OUI Medical Inc. is committed to advancing healthcare outcomes and is excited to share further developments as it progresses through the regulatory process and moves closer to bringing the P-Scope to the medical community and patients globally.
For more information about OUI Medical Inc. and the P-Scope, please visit [Your Website].
About OUI Medical Inc.:
OUI Medical Inc., established in 2021, is dedicated to the development and management of innovative medical devices. The company is focused on improving clinical outcomes and enhancing patient care through cutting-edge technology and safe, high-quality products.
Contact: Dr Adarsh M Patil
Email: ap@oui-medical.com
Phone: +919972446882
