Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Carrot, Quidel, Ortho Clinical Diagnostics, Uvision360.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aditxt, Bardy Diagnostics, Dariohealth, Hillrom, Histosonics, Tada Medical.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Cognetivity Neurosciences, Geneoscopy, Inotec AMD, Perspectum.
Xilis Inc. closed $70 million in series A financing on July 8 to reduce drug development costs leveraging its technology, with the goal of advancing precision medicine through targeted drug discovery and development. The financing was led by Mubadala Capital with participation from new investors that include GV, formerly Google Ventures, and others.
The FDA granted breakthrough device designation for the Hyalex Cartilage System, a biomimetic materials platform designed to restore function and repair cartilage defects in the knee. The system, developed by Hyalex Orthopaedics Inc., combines two polymers that improve adhesion on one side and create a low-friction surface that protects the cartilage counterface on the other.
A large health system in Minnesota recently became the first in the world to have completed a structural heart procedure, or any other surgical procedure for that matter, using any kind of 4D hologram technology. The technology was developed by venture capital-backed startup Echopixel Inc., and it is intended to improve both surgical precision and outcomes in minimally invasive procedures.
The World Health Organization (WHO) reported a new set of guidelines regarding screening and treatment of cervical cancer, endorsing DNA testing for human papillomavirus (HPV) as the recommended test method.
The U.S. Department of Justice (DoJ) has settled with two divisions of Abbott Laboratories of Abbott Park, Ill., over violations of the False Claims Act (FCA) in connection with devices alleged to have been defective. While neither claim recites a specific allegation against corporate executives with St. Jude Medical and Alere, the more conspicuous aspect of these agreements is that they are both directed toward activities that ceased in 2016, making clear that federal attorneys have long memories where problematic devices are concerned.
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