Carr Tech Corp's FROG Filter Needle Receives FDA Approval, Revolutionizing Medication Safety

Carr Tech Corp's FROG Filter Needle Receives FDA Approval



Carr Tech Corp, a Maryland-based medical device startup founded by pharmacist turned entrepreneur Sue Carr, has made waves in the healthcare industry with the recent FDA 510(k) Class II approval of its innovative product, the FROG Filter Needle. This groundbreaking all-in-one device aims to enhance safety and efficiency in medication preparation, addressing long-standing challenges in healthcare settings.

This achievement represents more than just an advance for Carr Tech; it signifies a triumph for healthcare professionals who have faced cumbersome drug preparation protocols and for patients seeking safer medication delivery. As Carr herself stated, “I am humbly grateful and happy to announce that we officially received FDA 510(k) Class II approval of FROG. This milestone is not just a win for Carr Tech—it's a win for every healthcare worker.”

Overview of the FROG Filter Needle



The FROG, which stands for Filter Removal of Glass, is the first all-in-one filter needle designed specifically to eliminate multiple steps involved in drawing medication from glass ampoules. Traditionally, healthcare workers needed to utilize separate filter and non-filter needles to avoid the risk of glass particle contamination, a process that was both time-consuming and prone to errors. The FROG's innovative design streamlines this workflow by consolidating these steps, significantly reducing potential procedural risks and enhancing overall patient safety.

Acquiring the 510(k) Class II approval is a challenging feat, illustrating that the FROG has been deemed “substantially equivalent” in safety and effectiveness to existing FDA market-approved devices. This regulatory clearance represents a critical hurdle for startups like Carr Tech, as industry data reveals that less than 12% of medical device startups successfully achieve FDA clearance, with the market entry process averaging substantial cost and time. Bringing a new device to market can exceed $30 million and take years to accomplish.

Sue Carr's Vision and the Team's Support



Sue Carr's journey with Carr Tech began with her experiences in hospital pharmacies, where she witnessed the dire consequences of filter failure in medical emergencies. Recognizing the potential for complications due to contaminated injections, she harnessed her pharmaceutical knowledge to create a user-friendly device that prioritizes safety and efficiency. Carr credits her supportive team and the broader network for their crucial role in achieving this important milestone.

“My heartfelt gratitude goes to the Carr Tech team, our amazing supporters, and especially to the Frederick Innovative Technology Center (FITCI) for being our home base,” Carr expressed during the announcement. FITCI has provided essential mentorship and resources for Carr Tech, which have been instrumental in their journey from idea to FDA approval.

Impact on Healthcare and Future Prospects



The FDA clearance for the FROG Filter Needle marks a pivotal moment not just for Carr Tech but for healthcare facilities nationwide. The company is now set to commence full-scale production and distribution, presenting a safer alternative to existing ampoule handling methods. Plans for global expansion of their manufacturing and distribution strategies are already in place.

“This approval empowers us to propel our mission to revolutionize medication safety,” Carr stated confidently as she addressed the future of Carr Tech Corp. With the FDA’s endorsement, the FROG is poised to be a game-changer in hospitals, surgical centers, and clinics, aiming to eliminate outdated procedures that have long burdened healthcare professionals.

As the healthcare industry continues to evolve, Carr Tech's journey underscores the importance of innovation driven by genuine concern for patient safety and health professional support. With the spotlight now shining brightly on Carr Tech and their pioneering FROG device, the future appears promising as they embark on this significant step forward in medication safety.

For more details about Carr Tech Corp and the innovative FROG device, visit www.carrtechcorp.com.

Topics Health)

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