Enochian Biosciences Inc.changed its name toRenovaro Biosciences Inc. and reported a deal to merge part of the company with Gedi Cube Intl Ltd. in an effort to move on from recent controversies. “Renovaro, Latin for ‘renewal,’ represents our company’s mission,” said Mark Dybul, CEO of the company.
Developers of medical technology have many concerns about the U.S. Centers for Medicare & Medicaid Services’ (CMS) handling of coverage and reimbursement, but those controversies have typically revolved around process. A new report sponsored by industry steers a somewhat different tack, however, arguing that while there are issues of process, one key issue is that of funding, a problem that only Congress can remedy.
Venostent Inc. has completed $16 million in series A financing to support a U.S. pivotal trial for bioabsorbable wraps designed to improve outcomes for hemodialysis patients suffering from end-stage renal disease (ESRD). This comes after Venostent was granted an FDA investigational device exemption (IDE) to begin its U.S. Selfwrap-assisted arteriovenous fistula study and breakthrough device designation of its technology awarded last year.
Histoindex Pte Ltd.'s’s artificial intelligence (AI)-enabled tissue imaging technology more accurately measures the change in fibrosis than current pathology tests, the company said.
In a study reported in the online edition of Science on Aug. 10, 2023, a group of synthetic biologists from the University of California (UC) San Diego and clinicians from Australia have engineered synthetic bacteria to detect specific DNA sequences in the genomes of colorectal cancer (CRC) cells and organoids. This living cell sensor capable of detecting cancer in the colons of mice has the potential to steer the way to new biosensors capable of identifying various infections, cancers and other diseases.
Accuray Inc. offered a classic good news-bad news set-up for investors on Wednesday, with a notable FDA 510(k) clearance balanced by a miss on fourth quarter revenue and projections for fiscal year 2024 significantly below consensus expectations. Still, the takeaway is generally positive, with several strong catalysts expected to build momentum for the company in the coming year and much of the underperformance attributable to foreign exchange headwinds that have plagued many med-tech companies.
A team from Siemens Medical Solutions Inc. presented a new artificial intelligence (AI) model that can predict people’s risk of multiple sclerosis (MS), at the 2023 American Association for Clinical Chemistry (AACC) annual scientific meeting in Anaheim, Calif.
Theranica Bio-Electronics Ltd. received expanded CE mark approval for Nerivio, a therapy that can both prevent and treat acute migraine in adults and adolescents. The Netanya, Israel-based company is now partnering with a large, publicly traded, pharmaceutical firm to launch the device later this year, first in Germany and then roll out commercial operations in several other European countries in 2024, Alon Ironi, CEO and co-founder of Theranica, told BioWorld.