Dermasensor Inc. received U.S. FDA clearance for its non-invasive skin cancer evaluation device that provides quantitative identification of all skin cancer types at the point of care and within seconds. The point-and-click device is designed to facilitate detection of skin cancers by primary care physicians (PCPs) and speed the time to diagnosis and treatment. Read More
Quibim SL recently launched its artificial intelligence (AI)-based software QP-Brain, which is designed to detect early-stage neurodegenerative diseases, after it received U.S. FDA 510(k) clearance, as well as CE and UKCA marks from the EU and U.K. regulators, respectively. QP-Brain quantifies and presents data from patients’ brain images to help clinicians with early diagnosis and treatment strategies for diseases such as Alzheimer’s, multiple sclerosis and dementia. Read More
The U.S. Centers for Medicare & Medicaid Services (CMS) issued the final rule for data interoperability and prior authorization (PA) for health plans, which is designed in part to improve the PA process used by payers. Read More
U.S. physicians who provide radiation services for cancer patients have a long-running feud with the Centers for Medicare & Medicaid Services over a series of payment rate cuts for their services, but these medical societies are now teaming up to address the issue. These medical societies are making the case that payment reform is not only critical for the future of radiation oncology but are also optimistic that congressional interest in the dilemma has quickened sufficiently to suggest that a congressional response may be on tap in 2024. Read More
December med-tech deals totaled $220 million, down 50.25% from $442.2 million raised in November. However, for the full year 2023, med-tech deal value reached $10.63 billion, the top year in BioWorld’s records going back to 2018, and up 33.1% from 2022’s $7.99 billion. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Karkinos, Mediforum, Personalis, Sensydia, Sophia Genetics, Vision Sensing. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bloomlife, Dermasensor. Read More