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FOR IMMEDIATE RELEASE: October 17, 2017
TransMed7, LLC Announces 510(k) Submission to the U.S. FDA for its SpeedBird Soft Tissue Biopsy Device Platform
Portola Valley, CA, October 17, 2017; TransMed7, LLC today announced that it has submitted a premarket notification for its innovative SpeedBird soft tissue biopsy device platform with the US Food and Drug Administration (FDA), under Section 510(k) of the Food, Drug and Cosmetic Act. “We are pleased to announce this 510K submission to the FDA, which represents the final countdown to the rapid market launch of our SpeedBird 38, Universal, and SBU 99 soft tissue biopsy devices in the United States, expected in the first quarter of 2018,” said Eugene H. Vetter, TransMed7’s Co-Founder and CEO.
The SpeedBird product platform of hand-held soft tissue biopsy devices has been designed to fulfill the needs of surgeons, radiologists, and other clinicians who desire better minimally invasive procedures through the use of next-generation, cost-effective, single insertion and multiple sample (SIMS) biopsy devices in a choice of sizes and which is designed to consistently and safely obtain higher quality biopsy samples from the breast, liver, kidney, prostate, spleen, lung, lymph nodes, and other soft tissue abnormalities identified by physical exam, X-rays, or ultrasound.
In anticipation of 510(k) clearance, TransMed7 is finalizing production and market introduction strategies for the SpeedBird product platform rollout for both domestic and international sales and distribution. Additionally, TransMed7 is continuing development of its portfolio of next generation products based on innovative variations of its patented “Zero5” working element, which include: Concorde™, a new platform technology for stereotactic and MRI based biopsy procedures; Cardinal, a fine-needle core biopsy device for breast, thyroid, and lymph nodes; and Cygnet, a novel device designed to establish continued access for intervention including aspiration and biopsy of bone marrow. TransMed7 is also currently developing Martinet™, a revolutionary new minimal access device for complete removal of target tissue.
According to Dr. James W. Vetter, TransMed7 Co-Founder and Chairman, “We are delighted to achieve this important milestone as it puts TransMed7 closer to its goal of developing critically needed, minimally-invasive medical technologies and getting them into the hands of clinicians for the benefit of their patients as quickly as possible.”
Caution: The SpeedBird 38, Universal, and SBU 99 soft tissue biopsy devices are investigational devices, which pending FDA clearance, are not as yet available for sale.