Haemonetics Received 510(k) Clearance From FDA For TEG 6s Hemostasis Analyzer System Global Hemostasis-HN Assay Cartridge
Portfolio Pulse from Benzinga Newsdesk
Haemonetics has received 510(k) clearance from the FDA for its TEG 6s Hemostasis Analyzer System Global Hemostasis-HN Assay Cartridge. This new cartridge enhances the TEG 6s system's capabilities, allowing it to serve fully heparinized patients undergoing adult cardiovascular surgeries/procedures and liver transplantation in both laboratory and point-of-care settings.

April 04, 2024 | 10:32 am
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Haemonetics' FDA clearance for its TEG 6s Hemostasis Analyzer System Global Hemostasis-HN Assay Cartridge is a significant regulatory milestone, expanding its application in critical medical procedures.
FDA clearance is a critical regulatory milestone that often leads to increased adoption and sales of medical devices. This clearance expands the TEG 6s system's applications to critical areas such as cardiovascular surgeries and liver transplants, potentially leading to increased demand and revenue for Haemonetics. Given the specificity of the clearance and its importance in expanding the device's use cases, this news is likely to be viewed positively by investors, potentially leading to a short-term uptick in Haemonetics' stock price.
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