In a significant development for Tenon Medical, a company at the forefront of revolutionizing care for patients afflicted with specific sacroiliac joint disorders, the US Food and Drug Administration (FDA) has successfully concluded a comprehensive Quality System Inspection Technique (QSIT) Level 2 Inspection at Tenon Medical headquarters. This milestone announcement has ignited a notable surge in Tenon Medical’s stock prices today.
At the time of this publication, Tenon Medical Inc stock (TNON) has witnessed a surge.
Tenon Medical Inc
Current Price: $1.18
Change : +0.33
Change (%): (38.68%)
Volume: 31.0M
Source: Tomorrow Events Market Data
The QSIT inspection, a rigorous evaluation aimed at gauging a medical device manufacturer’s adherence to the Quality System Requirements (QSR) and associated regulations, provides essential guidance to FDA investigators, ensuring a thorough and efficient inspection process. The inspection concentrates on critical components of a company’s Quality Management System.
Following the inspection, the FDA issues an FDA Form 483 to the management of the firm if any observed conditions are deemed by the investigator to potentially violate the Food Drug and Cosmetic (FD&C) Act or related Acts. These observations arise when the investigator determines that conditions or practices witnessed indicate that the device may be adulterated or could be prepared, packed, or stored under conditions that might render it harmful to health.
On November 1, 2023, at the conclusion of the inspection, the FDA investigator affirmed that there was no necessity to issue Form 483. The Closing Meeting proceeded without any observations or objectionable conditions identified. A final report detailing the findings will be provided to the company in the coming weeks.
CEO of Tenon Medical, Steve Foster, expressed his satisfaction with the inspection outcome, stating, “This inspection resulted in a Pass for Tenon Medical which is a tribute to the organization’s focus on our quality system. We are proud of our entire team, in particular operations, quality and regulatory groups as their diligence and standardized controls are a testament to the strict operational procedures we put in place at the formation of Tenon.”
The positive outcome of the FDA inspection marks a significant achievement for Tenon Medical, highlighting the company’s unwavering commitment to maintaining the highest standards in quality and regulatory compliance. The surge in stock prices reflects the confidence and optimism among investors regarding Tenon Medical’s continued success in the field of sacroiliac joint disorder care.
