Ethicon wins FDA nod for Enseal X1 tissue sealer

Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon  said today it won FDA 510(k) clearance for its Enseal X1 large jaw tissue sealer designed for vessel sealing and precise heat management. The Somerville, N.J.-based company said the newly cleared Enseal X1 is an advanced bipolar device designed for use in open procedures, such as colectomies and hysterectomies. “Ethicon remains committed to addressing the critical needs of patients, ensuring they have access to the most effective treatment through continued innovation and product enhancement. By providing access to leading-edge technology in advanced bipolar energy, we are giving hospitals the ability to work with a single advanced energy provider and surgeons increased choice and the flexibility to meet a diverse set of clinical needs for their patients and procedures,”  energy global strategic marketing veep Grace Chung said in a press release. In August, Ethicon announced a strategic collaborative deal with healthcare tech platform developer Touch Surgery to develop a collaborative simulated surgical training application. The companies hope to develop a free mobile application that can “reach medical professionals in even remote regions of the world” to improve patient outcomes. The application will bring together Ethicon’s history in surgical procedures and products and Touch Surgery’s tech platform which includes 3D simulations to provide training content for surgeons and students. Ear...
Source: Mass Device - Category: Medical Equipment Authors: Tags: 510(k) Food & Drug Administration (FDA) Regulatory/Compliance Surgical Ethicon Source Type: news