The FDA has rejected Artrya Ltd.’s 510(k) application for its Salix coronary anatomy (SCA) software that analyzes heart computed tomography scans via artificial intelligence (AI) to better diagnose coronary artery disease. “The FDA has advised that the Artrya Salix product is not equivalent to the predicate device,” Artrya CEO John Barrington told BioWorld.
Sarepta Therapeutics Inc. aims to resolve “very quickly” the clinical hold placed by the U.S. FDA on SRP-5051 (vesleteplirsen) for Duchenne muscular dystrophy (DMD), said Louise Rodino-Klapac, chief scientific officer.
The U.S. Department of Justice (DOJ) reported an indictment of a physician in Paducah, Kentucky for causing the filing of false claims to the Medicare program with the help of telehealth. The physician is liable for only $560,000 in penalties, but the announcement again underscores the department’s crackdown on telehealth fraud, regardless of the dollar value of the fraud.
Davita Inc., lost a U.S. Supreme Court ruling regarding limits to the private payer coverage for outpatient dialysis services despite, a development that took a double-digit bite out of Davita’s shares. However, shares of competitor Fresenius also took a hit, suggesting that the market sees the decision as a major setback for both companies.
Medtronic plc has received U.S. FDA 510(k) clearance and breakthrough device designation for its Ligapass 2.0 ligament augmentation system in spine surgery. The surgical treatment is designed to reduce the reoperation rate for proximal junctional kyphosis (PJK), a complication of adult spinal deformity surgery which disrupts spinal ligaments. Ligament augmentation provides strength to the upper instrumented vertebra and adjacent segments while also reducing junctional stress at those levels.
It’s been a decade since the America Invents Act (AIA) transformed the U.S. patent landscape from a first-to-invent to a first-inventor-to-file system and added new contours with the creation of the Patent Trial and Appeal Board (PTAB) to hear post-grant patent challenges outside of court. While the AIA’s inter partes review process and other post-grant procedures have helped weed out weak patents, they’ve also increased the uncertainty and unpredictability of many patents. Now, 10 years on, Congress is assessing how the PTAB has developed in real life and considering what course corrections may be needed.
The U.S. FDA reported a class I recall for a single lot of the Safestar 55 breathing filter system by Draeger Inc., due to partial obstruction of the filter, which can lead to hypoxia. The affected units were part of a lot that was to be destroyed, but were instead inadvertently distributed even though they were identified as unusable after a manual inspection process at Draeger.
The U.S. FDA gave Envoy Medical Corp. the thumbs up to conduct an early feasibility study of its Acclaim cochlear implant. The fully implanted system, which earned a breakthrough device designation from the FDA, aims to be the first cochlear implant to address hearing loss without the use of any external components.
Novartis AG is not going quietly into the night after the U.S. Court of Appeals for the Federal Circuit reversed itself, invalidating a method patent covering a dosing regimen for the company’s blockbuster multiple sclerosis drug, Gilenya (fingolimod). After the split opinion came down June 21 from the three-judge panel, Novartis said it planned to file a petition seeking further review of the decision by the full court.
The U.S. Centers for Medicare & Medicaid Services (CMS) had covered transcarotid artery revascularization for patients at high risk of poor outcomes during carotid artery endarterectomy to correct for stenosis, but the agency recently expanded that patient population to those at standard surgical risk. The news was lauded by the Society for Vascular Surgery (SVS) as a solid development for patients, given that this procedure’s complication rates are in many instances lower than seen in conventional endarterectomy.
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