There are a pair of approved CAR T drugs, Yescarta (axicabtagene ciloleucel) from Gilead Sciences Inc. and Kymriah (tisagenlecleucel) from Novartis AG, that have been available since 2017 for a few hematological cancers including some lymphomas and leukemias. But little is known about how these engineered chimeric antigen receptor T cells that both target CD19, an antigen prevalent in the cells of many B-cell malignancies, move through the body and proliferate after they are first removed, altered, expanded in number and, finally, returned to a patient's body.
The U.S. Centers for Medicare and Medicaid Services (CMS) has decided against a series of rate cuts for PET imaging in the Medicare physician fee schedule for 2020, a move lauded by physicians who were facing a rate cut of as much as 80% for nuclear medicine and molecular imaging procedures.
Navidea Biopharmaceuticals Inc. disclosed positive results from the first interim analysis of its ongoing NAV3-31 phase IIb study. Analysis shows the data support Navidea's hypothesis that Tc 99m tilmanocept imaging can provide robust, quantitative imaging in healthy controls and in patients with active rheumatoid arthritis (RA).
Magnetic resonance imaging (MRI) machines typically require a dedicated shielded room, as well as an additional room with electronics for analytics. That makes MRI, with a typical costly system that requires whole body immersion and elaborate facilities, not particularly feasible for many health care settings.
PARIS – Incepto Medical SAS, of Paris, raised $6.2 million from three French venture capital funds – Axa Venture Partners, Bpifrance through its Patient Autonome Fund, and Cap Decisif – to develop its artificial intelligence (AI) medical imaging platform. "This funding round is a first step toward accelerating [the] rollout of our [AI] medical imaging solutions on a grand scale throughout France," Incepto CEO Antoine Jomier told BioWorld MedTech.
The U.S. FDA has posted a draft guidance that will overwrite a 2014 draft guidance dealing with MRI compatibility for medical devices, but at least one observer is concerned that the agency posted draft as standards-setting organizations are rewriting their own related device performance standards, a fact that could draw out the time to completion of the draft.
A bipartisan group of 43 members of the U.S. House of Representatives has inked a letter to the U.S. Centers for Medicare and Medicaid Services (CMS), objecting to planned Medicare cuts for myocardial positron emission tomography (PET) imaging. The letter argues that the proposed rate cut of 72% would hamper access to a procedure that is typically provided in physician offices – and puts the onus on the CMS to justify the rate cut.
The field of artificial intelligence (AI) in medical practice is in its infancy, but a group of medical societies has published a paper that proposes the development of a code of ethics for artificial intelligence (AI) in radiology. The paper underscores a number of concerns, including that some developers fail to fully appreciate the potential consequences of seemingly innocent slip-ups in the development and validation of that algorithm.
Looking to help patients requiring imaging of lungs or other internal structures, researchers from the NIH and Siemens Healthineers AG, of Erlangen, Germany, have developed a high-performance, low magnetic-field magnetic resonance imaging (MRI) system that also could prove safer for those with pacemakers or defibrillators.
PERTH, Australia – Telix Pharmaceuticals Ltd. raised AU$40 million as it prepares regulatory packages and commercial strategies in Europe, the U.S. and Australia.