Curated News
By: NewsRamp Editorial Staff
November 04, 2024
United Health Products, Inc. Provides Update on FDA Approval Process
Discuss on Reddit
LinkedIn
Substack
Telegram
GithubTLDR
- UHP's clinical trial results show superiority for time to hemostasis with CelluSTAT, giving the company an edge in the market.
- UHP's FDA PMA application process involves addressing deficiencies and proposing an extension of the original pivotal study to gather more data.
- CelluSTAT's effectiveness in controlling bleeding can improve patient outcomes, making surgical procedures safer and more successful.
- UHP's update on the FDA PMA application process provides insight into the company's progress and future direction in the medical field.
Impact - Why it Matters
This news matters as it provides insights into the progress of United Health Products, Inc.'s FDA approval process and the potential impact on the availability of their hemostatic product, CelluSTAT, in the human surgical market.
Summary
United Health Products, Inc. provides an update on their FDA Premarket Approval application process, following a videoconference with the FDA to discuss the company’s proposed resolutions to the deficiencies in its PMA application. The meeting addressed topics such as clinical testing, biocompatibility, product sterilization, and shelf life. The company also noted the results of its clinical trial involving 232 patients, showing non-inferiority and superiority for time to hemostasis using CelluSTAT relative to the standard of care.
Source Statement
This curated news summary relied on this press release disributed by NewMediaWire. Read the source press release here, United Health Products, Inc. Provides Update on FDA Approval Process
