Kardium Inc. landed $104 million in new financing for its Globe mapping and ablation system for atrial fibrillation, positioning it to enter the rapidly changing field in the U.S. The funds will allow the company to finish its PULSAR trial, secure FDA approval and launch its pulsed field ablation system commercially, Kardium Chief Financial Officer Koert VandenEnden told BioWorld. Read More
Amber Implants BV reported promising results from the first-in-human trial of patients fitted with its Vcfix spinal system which treats vertebral compression fractures. Data showed that patients experienced significant pain relief and regained the ability to walk without discomfort. Read More
As renal denervation (RDN) makes a comeback for treatment-resistant hypertension, Deepqure Inc. is advancing its RDN medical device dubbed Hyperqure with the U.S. FDA granting clearance for a U.S.-based study. Read More
Dublin-based Medtronic plc. has issued an urgent device correction letter to customers using the company’s Stealthstation robotic surgical system due to a software error that may provide inaccurate information about the location of the system’s surgical tip in the cranial anatomy. Read More
The U.S. appeals court for the District of Columbia has reversed a lower court’s ruling that the device industry cannot appeal a Library of Congress rule that allows third-party access to the software used to govern the operations of medical devices. While the latest outcome in this controversy is a win for device makers, the trajectory of this case is anything but certain as the next step may be an en banc hearing at the circuit court or an appeal to the U.S. Supreme Court. Read More
New hires and promotions in the med-tech industry, including: Axosim, Biosig, C2Sense, Cutera, Delphinus, Envoy Medical, GE Healthcare, Orthofix Medical. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Softwave, SS Innovations. Read More
