Ra Medical Systems Inc. launched a simple device that holds sutures more securely in place for closure of percutaneous wound sites during cardiac electrophysiology, structural heart and vascular surgical procedures.
The U.S. Supreme Court has declined to grant cert for a petition filed by Johnson & Johnson on behalf of its Ethicon subsidiary to review a case in California that will cost the company more than $300 million. The outcome highlights the differential hazards of advertising and promotion in various U.S. states, with California state law allowing fines of up to $2,500 for each violation of state law, an amount that can quickly tally into the hundreds of millions.
The U.S. CMS has unveiled a proposed national coverage determination for powered seat elevation systems for Group 3 power wheelchairs, one of the more expensive items in the category of mobility durable medical equipment (DME). However, the agency indicated that it will soon examine coverage of powered seat elevation systems for Group 2 power wheelchairs, the combination of which suggests that manufacturers in the DME space are looking at a market that seems poised to explode.
A cancer therapy test unveiled by Exact Sciences Corp. will be able to provide a complete molecular picture of a patient’s tumor allowing for them to receive the most effective treatment as quickly as possible. Exact’s Oncoextra therapy selection test, recently launched in the U.S., enhances the ability of doctors to characterize and understand solid tumors.
GE Healthcare Technologies Inc. reported a recall of several systems in its nuclear medicine line of high-end imaging systems for two potential issues that could lead to the collapse of a detector weighing more than half a ton onto the patient. According to the U.S. FDA listing for the recall, no injuries or fatalities have been reported in connection with these issues, but the announcement resurrects an episode from 2013 in which a patient in New York lost his life when a nuclear imaging camera collapsed during an imaging procedure.
Esophageal cancer is often referred to as the “silent killer” because few people show any symptoms until after the cancer has spread. If localized, five-year survival rate is 46%, but that drops to just 5% when malignancy has reached distant parts of the body.
Merit Medical Systems Inc. received a U.S. FDA breakthrough device designation for its Scout MD surgical guidance system, which enables physicians to pinpoint tumor location in soft tissue. The system uses up tiny reflectors to provide multidimensional location data that can improve the ability to remove the entire tumor with minimal trauma to the surrounding tissue, which can be a challenge in surgeries such as lumpectomies.
Neurodiagnostics LLC (dba Synaps Dx) and Linus Health Inc. reported significant advances for their dementia diagnostics Feb. 16, adding to the liquid biopsies and radiologic studies currently used and potentially expanding access to beneficial treatments for Alzheimer’s disease (AD) and other dementias.
The U.S. FDA granted 510(k) clearance to Hyperfine Inc. for improved artificial intelligence (AI)-powered software for its Swoop portable magnetic resonance imaging (MRI) device. The company launched the new software this week.
The patent wars over the design of transcatheter aortic valve replacement (TAVR) devices seemed to disappear roughly nine years ago, but there is at least one more episode for Dublin-based Medtronic plc before the company could lay the issue to rest. A jury declared that Medtronic is liable for more than $100 million in damages over alleged infringement of a patent held by Broomfield, Colo.-based Colibri Heart Valve LLC, but the contested patent has expired, and Medtronic said it intends to pursue the matter further.
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