Dallas, TX – July 31, 2024 – OUI Medical, a pioneering medical device startup, is proud to announce that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its groundbreaking P-Scope, a minimally invasive diagnostic device designed for the examination of the abdominal cavity under local anesthesia.
The FDA’s clearance of the P-Scope, under the regulatory number K241502, confirms that the device is substantially equivalent to legally marketed predicate devices and meets all necessary regulatory standards. The P-Scope is set to revolutionize abdominal examinations by providing a cost-effective, safer, and more convenient alternative to traditional laparoscopy and laparotomy, which often require general anesthesia and are associated with higher costs and increased patient discomfort.
Key Features of the P-Scope:
- Minimally Invasive: Designed for use under local anesthesia, making procedures less invasive and more accessible.
- Single-Use: Ensures sterility and eliminates the risk of cross-contamination.
- Cost-Effective: Lowers the acquisition cost and eliminates the need for extensive sterilization processes.
- portable: Ideal for use in outpatient settings and remote locations, expanding access to critical diagnostic procedures.
Dr. Adarsh M Patil, Founder and Chief Executive Officer of OUI Medical, stated, “Receiving FDA 510(k) clearance is a monumental milestone for OUI Medical. The P-Scope embodies our commitment to innovation in medical technology, aiming to enhance patient outcomes and reduce healthcare costs. We are excited to bring this game-changing device to market and transform how abdominal examinations are conducted.”
The P-Scope’s development and FDA clearance were supported by rigorous testing and validation, ensuring the device meets the highest standards of safety and efficacy. The device’s unique design and functionality cater to a wide range of applications, including cancer care, digestive health, women’s health, emergency care, and postoperative care.
OUI Medical Team: The success of the P-Scope is driven by a team of experts, including Dr. Adarsh M Patil, an experienced laparoscopic and bariatric surgeon, and co-founder Hrishikesh Gadagkar, a seasoned engineer in the MedTech industry. The team is complemented by strategic advisors with extensive backgrounds in healthcare innovation, clinical research, and regulatory affairs.
Market Potential: The global endoscopy market is estimated at $40 billion, with the single-specialty scope market accounting for approximately $4 billion annually. The P-Scope addresses a significant gap in this market by offering a less invasive and more cost-effective solution for abdominal examinations. With the growing demand for minimally invasive surgical procedures, the P-Scope is poised for rapid adoption and significant impact.
About OUI Medical: Founded in 2023, OUI Medical is a Dallas-based medical device company dedicated to developing innovative solutions for minimally invasive surgeries. With a focus on improving patient outcomes and reducing healthcare costs, OUI Medical is committed to advancing the field of diagnostic endoscopy.
For more information about OUI Medical and the P-Scope, please visit www.oui-medical.com or contact:
Contact:
Dr. Adarsh M. Patil
OUI Medical Inc.
3000 Pegasus Park Dr, Suite 1330
Dallas, TX 75247
