The Surveillance Heartcare Outcomes Registry trial demonstrated that Caredx Inc.’s Heartcare test identifies acute cellular rejection in heart transplant patients better than donor-derived cell-free DNA (dd-cfDNA) alone, while reducing biopsies and improving clinical outcomes. Heartcare combines two non-invasive tests, dd-cfDNA and Allomap Heart gene-expression profiling. Read More
Medtronic plc said its investigational Omniasecure defibrillation lead met its primary safety and effectiveness endpoints and exceeded prespecified performance goals, in the global Lead Evaluation for Defibrillation and Reliability (LEADR) pivotal trial. Read More
The U.S. FDA has several methods for signaling its enforcement intentions regarding medical devices and drugs, but there are times when warning letters are the vectors for communicating the agency’s current thinking. Read More
Citing the need to protect the public interest, the U.S. Department of Health and Human Services ordered an immediate government-wide funding suspension May 15 of Ecohealth Alliance Inc. while formal debarment proceedings are pending against the New York-based nongovernmental organization. Read More
Denver-based Arcscan Inc. gained Chinese approval of its computer-controlled, ultra-high frequency ultrasound diagnostic imaging solution for myopia called Insight 100, expanding its reach beyond the U.S. and Europe. Read More
Wubin Bai, assistant professor of applied physical sciences at UNC-Chapel Hill, is seeking protection for morphable 3D-folded microelectronic mesostructures, including epicardial bioelectronic probes, made using concepts borrowed from origami. Read More
New hires and promotions in the med-tech industry, including: Full-Life Technologies, Merit Medical Systems, Osteotec, Quest Diagnostics, Spectral AI. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Adagio, Circle Cardiovascular, Cook, Enterasense, Inheart, Lifecore, Oxford Biodynamics, Siemens Healthineers, Varian. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Axonics, BD, Brainomix, Diasorin, Implicty. Read More
The recent cyberattack on Change Healthcare, a part of the Unitedhealth Group, crippled reimbursement claims processing for thousands of providers for several weeks and potentially exposed troves of patient data. Congressional committees are investigating the attack, its scope, and Unitedhealth’s response. Please take a few minutes to fill out this short survey to help BioWorld understand how your company is responding to these threats. You can click through to the questions here. Read More
