Agfa HealthCare announces that it has received FDA 510(k) clearance for the XERO Xtend functionalities of the Enterprise Imaging zero-footprint viewer. XERO Xtend adds 3D processing and advanced clinical applications to the XERO Viewer. It is now FDA-cleared for diagnostic viewing on desktop devices.1 The release data for 510K cleared XERO Xtend will be communicated by Agfa HealthCare’s regional sales …

Beckman Coulter Diagnostics introduces its DxONE information management solutions, an integrated system of technologies and capabilities, designed to ease data access and usability. DxONE is designed in response to the increasing challenges faced by laboratory technicians to expedite result times, reduce costs, maneuver personnel shortages and navigate network consolidations. The suite of next-generation technologies applies cloud-computing to provide remote-access functionality …

Roche announced the commercial availability of the AVENIO Millisect System, a tissue dissection instrument that utilizes an automated digitally assisted process to reliably and efficiently isolate clinically relevant cells from formalin-fixed paraffin-embedded (FFPE) tissue slides. The AVENIO Millisect System addresses challenges inherent in today’s tissue dissection practice in the clinical lab workspace where manual dissection lacks consistency and precision, and …

Roxwood Medical Inc. announced it has entered into an exclusive agreement with Abbott for distribution of Roxwood products in the United States. “This partnership with Abbott’s vascular business is a major milestone for Roxwood that allows far more patients to benefit from our catheter portfolio used during complex coronary procedures,” said Mehrdad Farhangnia, chief executive officer, Roxwood Medical. “We have …

Vertera Spine announced the COALESCE™ Lumbar Interbody Fusion Device has received U.S. Food and Drug Administration (FDA) 510(k) clearance for use in anterior, transforaminal, posterior, and lateral lumbar interbody fusion procedures. COALESCE features Vertera Spine’s novel proprietary porous PEEK biomaterial and is the second porous PEEK device to receive FDA clearance behind Vertera Spine’s COHERE® Cervical Interbody Fusion Device. Vertera …

Northwell Health has signed an agreement with the Israel Innovation Authority (IIA) to collaborate on the development, validation and implementation of medical innovations that advance patient care. Representing hundreds of medical technology start-up companies in Israel, the IIA is a government-backed agency that partially funds newly founded companies to help them develop and bring their products to market. Israel is …

Samsung’s BodyTom, the world’s first portable, full-body, 32-slice CT (computed tomography) scanner, just got even better. The BodyTom Elite® is the newly upgraded BodyTom, which received FDA 510(k) clearance on June 14, 2017. Incorporating a fresh new visual design, upgraded software, hardware and workstation the BodyTom Elite will make its mark as the go-to premium advanced full-body mobile CT scanner. …

Siemens Healthineers has entered into a definitive agreement to acquire Epocal Inc., a subsidiary of Alere Inc. Epocal Inc. develops and provides point-of-care blood diagnostic systems for healthcare enterprises, including the epoc® Blood Analysis System, a handheld, wireless testing solution. Financial details of the transaction are not being disclosed. The transaction is subject to the completion of Abbott’s acquisition of …

Siemens Healthineers has entered into a definitive agreement to acquire Epocal Inc., a subsidiary of Alere Inc. Epocal Inc. develops and provides point-of-care blood diagnostic systems for healthcare enterprises, including the epoc® Blood Analysis System, a handheld, wireless testing solution. Financial details of the transaction are not being disclosed. The transaction is subject to the completion of Abbott’s acquisition of …

To drive quality and improve health outcomes for its Medicaid and Medicare Advantage members, WellCare of Kentucky, a subsidiary of WellCare Health Plans, Inc. formed a new value-based care partnership with St. Elizabeth Healthcare, the largest health system in northern Kentucky. Health care organizations now emphasize payments based on quality of care, rather than just paying according to how many …