Vomaris Inc. introduced its U.S. FDA-cleared Powerheal bioelectric bandage for over-the-counter use following studies showing a shocking 99.99% reduction in bacteria present in wounds covered with the bandage even without the use of antibiotics. The bandage’s electrical energy also stimulates cell movement, cutting healing time in half, a study found.
The U.S. Department of Justice announced that Keith Berman, formerly the CEO of Los Angeles-based Decision Diagnostics Corp., has received a prison sentence of seven years for misrepresenting the company’s developmental test for the SARS-CoV-2 virus during the height of the COVID-19 pandemic.
In the inpatient draft for fiscal 2025, the U.S. Centers for Medicare & Medicaid Services has proposed an accountable care model for beneficiaries on fee-for-service care, one which is designed to provide the coordination of care ordinarily seen only in accountable care organizations.
Laboratory Corp. of America Holdings introduced a glial fibrillary acidic protein blood-based test available commercially in the U.S. for the early detection of neurodegenerative diseases and brain injuries. The test, which the company said was the first of its kind, is designed to assess the presence and progression of Alzheimer’s disease, multiple sclerosis, glioblastoma and traumatic brain injury.
The University of Florida Health Proton Therapy Institute’s director of Physics, Perry Johnson, has filed for protection of a method for patient posture and alignment using mixed reality (MixR) visualization.
The U.S. Centers for Medicare & Medicaid Services has proposed a few significant changes to the new technology add-on program for the fiscal year 2025 inpatient prospective payment system, including a boost in NTAP rates for gene therapy services.
Prenosis Inc. gained U.S. FDA de novo marketing authorization for an artificial intelligence-powered rapid diagnostic tool for sepsis, one of the most challenging and deadly conditions in hospitals and reported a distribution agreement with Roche Holding AG. Another pairing also made progress in developing a sepsis in vitro diagnostic this week, as Bosch Healthcare Solutions GmbH and Randox Laboratories Inc. joined forces and committed €150 million (US$159.63 million) to the effort.
The Hatch-Waxman Act provides a safe harbor that allows importation of an FDA-regulated article that would otherwise be deemed a case of patent infringement so long as the importation is for purposes reasonably related to obtaining regulatory approval. Edwards Lifesciences Corp. sued Meril Life Sciences Pvt Ltd. for importation of heart valves in a manner that Edwards argued was infringement under Hatch-Waxman, but while the Federal Circuit ruled 2-1 against Edwards, the dissenting opinion recommended an appeal to a full 12-judge panel that could reverse this outcome.
Finding an effective medication for patients with major depressive disorder is notoriously difficult, with 70% of patients failing to respond to the first drug prescribed and 30% not responding to the first four medications. Complicating matters, genetic mutations can increase psychotropic drug-related adverse events, including hospitalizations. A recent study indicates Myriad Genetics Inc.’s Genesight test can help minimize the risk of these negative events, with a reduction of nearly 40% in psychiatric-related hospitalizations and prescription of medications with significant gene-drug interactions.
Exact Sciences Corp., Seekin Inc. and Serum Detect Inc. presented encouraging results for the field of multicancer early detection at the American Association for Cancer Research annual meeting in San Diego April 6-10, but delays in coverage may slow further progress.