| JNPMEDI, Accelerates Global Expansion of A-Stream with FDA Team
| Maven Clinical Cloud Enhances Data Management and Regulatory Response
(Left) JongCheol Han, CEO of MICROT, (Right) KwunHo Jeong, CEO of JNPMEDI
JNPMEDI (CEO KwunHo Jeong) announced on the 6th that it has signed a Memorandum of Understanding (MOU) with MICROT (CEO JongCheol Han) to secure FDA 510(k) approval for the ultra-small glaucoma implant, A-Stream. A-Stream is a medical-grade silicone device measuring 6mm in length and 100μm in inner diameter, offering excellent intraocular pressure reduction, high biocompatibility, and safety.
Through this agreement, JNPMEDI will provide dedicated support for the FDA 510(k) approval process and use its Maven Clinical Cloud to efficiently manage and analyze clinical trial data. Maven Clinical Cloud is expected to play a crucial role in meeting FDA regulatory requirements by ensuring accurate and consistent data management throughout the trial.
FDA 510(k) approval is a complex process where a new medical device must prove to be substantially equivalent in safety and efficacy to an existing device. JNPMEDI will lead the entire approval procedure, including clinical trial design, regulatory documentation, and coordination with the FDA.
KwunHo Jeong, CEO of JNPMEDI stated, "We will optimize data management and analysis through Maven Clinical Cloud to accelerate A-Stream's global market entry. Leveraging our FDA approval expertise, we will actively support A-Stream in becoming a global medical device."
JongCheol Han, CEO of MICROT added, "A-Stream is an innovative product that offers a safer and more effective treatment option for glaucoma patients. JNPMEDI's approval experience and technical support will be invaluable in accelerating A-Stream's global commercialization."
A-Stream offers more effective and safer intraocular pressure control compared to existing glaucoma treatments, with the added benefit of shortened recovery time due to its ultra-small design. Once FDA 510(k) approval is secured, A-Stream is expected to become an innovative treatment option for glaucoma patients worldwide.
| JNPMEDI, Accelerates Global Expansion of A-Stream with FDA Team
| Maven Clinical Cloud Enhances Data Management and Regulatory Response
(Left) JongCheol Han, CEO of MICROT, (Right) KwunHo Jeong, CEO of JNPMEDI
JNPMEDI (CEO KwunHo Jeong) announced on the 6th that it has signed a Memorandum of Understanding (MOU) with MICROT (CEO JongCheol Han) to secure FDA 510(k) approval for the ultra-small glaucoma implant, A-Stream. A-Stream is a medical-grade silicone device measuring 6mm in length and 100μm in inner diameter, offering excellent intraocular pressure reduction, high biocompatibility, and safety.
Through this agreement, JNPMEDI will provide dedicated support for the FDA 510(k) approval process and use its Maven Clinical Cloud to efficiently manage and analyze clinical trial data. Maven Clinical Cloud is expected to play a crucial role in meeting FDA regulatory requirements by ensuring accurate and consistent data management throughout the trial.
FDA 510(k) approval is a complex process where a new medical device must prove to be substantially equivalent in safety and efficacy to an existing device. JNPMEDI will lead the entire approval procedure, including clinical trial design, regulatory documentation, and coordination with the FDA.
KwunHo Jeong, CEO of JNPMEDI stated, "We will optimize data management and analysis through Maven Clinical Cloud to accelerate A-Stream's global market entry. Leveraging our FDA approval expertise, we will actively support A-Stream in becoming a global medical device."
JongCheol Han, CEO of MICROT added, "A-Stream is an innovative product that offers a safer and more effective treatment option for glaucoma patients. JNPMEDI's approval experience and technical support will be invaluable in accelerating A-Stream's global commercialization."
A-Stream offers more effective and safer intraocular pressure control compared to existing glaucoma treatments, with the added benefit of shortened recovery time due to its ultra-small design. Once FDA 510(k) approval is secured, A-Stream is expected to become an innovative treatment option for glaucoma patients worldwide.