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Kihealth Completes Pre-Submission Meeting with FDA for Beta First Test
eTradeWire News/10786216
ST. AUGUSTINE, Fla. - eTradeWire -- St. Augustine, FL — 10.31.24 — Kihealth, a leader in precision health technology, is excited to announce that it has successfully completed its pre-submission meeting with the U.S. Food and Drug Administration (FDA) regarding its innovative Beta First test. This milestone marks a significant step forward in the company's mission to revolutionize metabolic health assessment.
The Beta First test leverages cutting-edge technology to provide accurate diagnostics for beta cell function, aiming to enhance early detection and treatment of diabetes. The pre-submission meeting with the FDA was an opportunity for Kihealth to engage with regulatory experts, gain valuable feedback, and clarify the pathway for the test's submission.
"We are thrilled to have completed this important milestone with the FDA," said Jenna Anderson, CEO at Kihealth. "The insights gained from this meeting will be instrumental as we move forward with our efforts to bring the Beta First test to market. Our commitment to improving patient outcomes through innovative diagnostic solutions remains our top priority."
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Kihealth anticipates that the Beta First test will not only assist healthcare providers in making more informed treatment decisions but also empower patients by providing them with critical information about their metabolic health. This aligns with Kihealth's dedication to preventative care and personalized medicine.
The company plans to submit its DeNovo application to the FDA in the coming months, with the goal of making the Beta First test available to healthcare professionals and patients as soon as possible.
For more information about Kihealth and its pioneering diagnostic solutions, please contact the company at info@kihealth.com.
About Kihealth
Kihealth is dedicated to advancing precision health through innovative technology and diagnostics. By focusing on metabolic health and diabetes management, Kihealth aims to empower both healthcare providers and patients with the tools needed for improved health outcomes.
Media Contact
info@Kihealth.com
www.kihealth.com
The Beta First test leverages cutting-edge technology to provide accurate diagnostics for beta cell function, aiming to enhance early detection and treatment of diabetes. The pre-submission meeting with the FDA was an opportunity for Kihealth to engage with regulatory experts, gain valuable feedback, and clarify the pathway for the test's submission.
"We are thrilled to have completed this important milestone with the FDA," said Jenna Anderson, CEO at Kihealth. "The insights gained from this meeting will be instrumental as we move forward with our efforts to bring the Beta First test to market. Our commitment to improving patient outcomes through innovative diagnostic solutions remains our top priority."
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Kihealth anticipates that the Beta First test will not only assist healthcare providers in making more informed treatment decisions but also empower patients by providing them with critical information about their metabolic health. This aligns with Kihealth's dedication to preventative care and personalized medicine.
The company plans to submit its DeNovo application to the FDA in the coming months, with the goal of making the Beta First test available to healthcare professionals and patients as soon as possible.
For more information about Kihealth and its pioneering diagnostic solutions, please contact the company at info@kihealth.com.
About Kihealth
Kihealth is dedicated to advancing precision health through innovative technology and diagnostics. By focusing on metabolic health and diabetes management, Kihealth aims to empower both healthcare providers and patients with the tools needed for improved health outcomes.
Media Contact
info@Kihealth.com
www.kihealth.com
Source: Kihealth inc.
Filed Under: Health
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