Beneficiaries in the U.S. Medicare program have access to several technologies and procedures for treatment of glaucoma, but Medicare administrative contractors (MACs) seem to be looking sideways at some of these offerings. Both Wisconsin Physician Services and Palmetto GBA have floated draft local coverage proposals that deem procedures such as goniotomy and the combination of canaloplasty and trabeculectomy to be investigational, suggesting that claims for these and other services and devices will not be paid by these MACs.
Another brick in the ambitious Human Cell Atlas initiative has been put into place with the publication of the largest and most comprehensive cell map of the human lung. The open and freely available atlas catalogs the diversity of cells in the lung, including rare and previously undescribed cell types.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Foundation Medicine, Inspire Medical Systems.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Dxvx, Edgecap, Eitan Medical, LTS, Soteria, T2 Biosystems.
The U.S. FDA’s September 2022 guidance for clinical decision support (CDS) software was controversial the moment the agency posted the document, prompting the filing of a citizen’s petition five months later. The CDS Coalition has penned a June 8 letter to FDA commissioner Robert Califf in an effort to draw a reaction from the agency, but the letter was accompanied by a summary of an analysis of CDS software with a machine learning (ML) component that suggests that such products that are in development may have to be reconsidered.
Asep Medical Holdings Inc. reported “ground-breaking” use of artificial intelligence in its SepsetER test to rapidly identify infections at increased risk of severe sepsis. Developed under guidance by Professor Robert E.W. Hancock at the University of British Columbia, analysis of dysfunctional immune responses to identify particular sets of genes could signal when a patient is at risk of acquiring and potentially dying from severe sepsis.
GE Healthcare Technologies Inc. has launched Sonic DL, a deep learning technology designed to significantly accelerate magnetic resonance imaging (MRI) exams, after receiving regulatory clearance from the U.S. FDA.