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.
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.
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.
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.
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.
The FTC’s request for a nearly 25% increase in funding for fiscal 2025 was splashed with cold water May 15 in a U.S. House Appropriations subcommittee hearing. That’s “a dramatic increase in funding for an agency whose work continues to raise concerns among many members of Congress and the public,” Rep. David Joyce (R-Ohio), chair of the Subcommittee on Financial Services and General Government, said as he opened the hearing.
The Biosecure Act passed its first milestone in the U.S. House May 15 when the Oversight Committee voted 40-1 to favorably report the bill to the full House for a vote. Under the act, H.R. 8333, federal agencies would be prohibited from procuring biotechnology equipment or services from a “biotechnology company of concern” and from contracting, either directly or through a subcontract, with anyone that would use such equipment or services to perform the contract.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acclaro Medical, FX Shoulder Solutions, Karius, Notal Vision, Sonio.