Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Caldwell Industries, CM Life Sciences, Dexcom, Encore, Ensodata, Fresenius Medical Care, Humacyte, Integra Molecular, Predictmedix, Sema4, Shockwave Medical, Sientra, Vivante Health.
Xenco Medical LLC debuted its glasses-free holographic surgical simulation platform, Holomedx, enabling patients and their surgeons to understand the nuances of spinal procedures before they get underway. The company will begin deploying the virtual reality (VR) training tool for nondiagnostic use at select sites during the week of June 14.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Accuray, Avita Medical, Canon Medical, Desktop Health, Medtronic, Neurescue, Nuvo Group.
PARIS – Arkhn SAS has finalized a $5 million seed round to help drive health care institutions towards secure and efficient data management. This financing round has been led jointly by the two French venture capital firms, Kurma Partners SA and Newfund SA, though their respective funds Kurma Diagnostics II and Newfund II.
Imagine an orthopedic implant that not only accelerates bone healing but also captures data to support real-time clinical decisionmaking. That’s the vision of Intelligent Implants Ltd., whose Smartfuse system recently won FDA breakthrough device designation. The first indication is for lumbar spinal fusions.
Dsruptive Subdermals AB has completed a clinical showing body temperatures tracked by its chip implants are comparable to temperature readings from standard clinical thermometers. The Stockholm-based startup is now offering its injectable implants as an open platform for researchers seeking efficient, low-cost tools to monitor changes in body temperature.
Alivecor Inc. has elevated its patent dispute with Apple Inc. to the U.S. International Trade Commission (ITC) in a move that could damage the latter’s foray into digital health. Alivecor is alleging that Apple, of Cupertino, Calif., has infringed on Alivecor patents for electrocardiogram monitoring technology, a development that may foreshadow a continuing legal struggle between the two companies for a large and rapidly growing market.
Edwards Lifesciences Corp. has won the FDA’s nod for its Acumen hypotension prediction index (HPI) software with the Acumen IQ finger cuff. Prior to receiving this 510(k) clearance, the low blood pressure prediction software was only available for patients using an invasive arterial line. The Acumen HPI software uses data gleaned from the Acumen IQ cuff, along with machine learning, to alert clinicians if a patient is at risk of hypotension, drops in pumping pressure that reduce the flow of oxygenated blood and nutrients to the body’s vital organs.