Lineus Medical Approved by FDA for Selling its First Medical Device

Lineus Medical, a healthcare technology business based in Fayetteville, said Tuesday (June 1) that the US Food and Drug Administration (FDA) had certified its first medical device, SafeBreak Vascular, for sale. According to a press statement, it’s the first Force-Activated Separation Device approved for sale in the United States through the FDA’s De Novo review procedure.

Spencer Jones, the founder, and chief technology officer of Lineus Medical, said, “Achieving FDA De Novo Designation as a Class II device is no doubt the biggest milestone to date for our company. We’re ecstatic about reaching this inflection point and eager to start executing on our product launch plan. It took an incredible amount of perseverance, a lot of investment and a talented team to overcome the challenges we faced along the way.”

MediCore of Nashville, Tenn., distributes SafeBreak Vascular on behalf of Lineus Medical and several other independent sub-distributors in the United States. MediCore distributes other vascular access products to over 1,100 institutions in the United States. Lineus, originally LineGard Med, was created in May 2015 to develop and commercialize SafeBreak Vascular.

When tension higher than 4 pounds of force is applied to a peripheral IV line, the device decreases mechanical difficulties that require IV restarts, according to the press release. IV line tugs and pulls are typical during a patient’s stay in the hospital. Adhesive dressings and securement devices are currently used to keep IV catheters secure. When the IV tubing is subjected to enormous draw forces, these approaches fail because they focus on attaching the line to the patient’s skin.