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.
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.
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.
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.
For the U.S. FDA’s Peripheral and Central Nervous System Drugs Advisory Committee, the medical need and the effectiveness of Eli Lilly and Co.’s Alzheimer’s candidate, donanemab, outweighs the safety concerns and lack of data for underrepresented groups and special needs patients. The panel voted unanimously, 11-0, June 10 that the available data show donanemab is effective in treating Alzheimer’s in the population enrolled in Lilly’s clinical trials and that the benefits of the amyloid-targeting monoclonal antibody outweigh the risks in the study population of patients with mild cognitive impairment and mild dementia.
Abbott Laboratories received U.S. FDA clearance for its Lingo and Libre Rio over-the-counter continuous glucose monitoring systems, enabling it to challenge Dexcom Inc. in this rapidly growing market. Dexcom received FDA clearance for its OTC Stela continuous glucose monitor in March.
Geron Corp., a company founded more than three decades ago, is finally celebrating its first U.S. FDA approval. The agency cleared imetelstat, branded Rytelo, for use in transfusion-dependent anemia in adults with low- to intermediate-risk myelodysplastic syndromes, specifically those requiring four or more red blood cell units over eight weeks who have failed or no longer respond to erythropoiesis-stimulating agents (ESA) or who are not eligible for ESA treatment.
The U.S. FDA clamped a full clinical hold Biomea Fusion Inc.‘s phase I/II study of BMF-219 for treating type 1 diabetes and type 2 diabetes. The hold sank the stock on June 7 as the company looked to find answers so it could sit down with the agency to discuss next steps.
Moon Surgical SAS recently received U.S. FDA clearance for the commercial version of its Maestro surgical robotic system for laparoscopic procedures. The greenlight is “pretty massive” for the company as it will allow the robotic platform to be rolled out in the U.S., to help enhance the surgeon’s performance while carrying out procedures, Anne Osdoit, CEO of Moon Surgical, told BioWorld.
Washington-based Vanda Pharmaceuticals Inc. has faced a challenging few years involving a federal lawsuit against the U.S. FDA, patent infringement litigation, increasing generic competition and dwindling sales, as well as a complete response letter nixing plans to expand its melatonin receptor agonist Hetlioz (tasimelteon) into insomnia, yet it has recently received a higher, unsolicited acquisition offer of $466 million from a second company, Cycle Pharmaceuticals Ltd.
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