Mediwound Ltd. reported that the Nexobrid expanded treatment access protocol achieved complete debridement in 94.9% of adults and all children treated and removed all eschar within 24 hours. The results put more power behind a partnership with Vericel Corp. that introduced Nexobrid, an enzymatic debridement agent for severe thermal burns, into the U.S. in the fourth quarter of 2023 and increases the likelihood of an indication expansion into pediatrics. Read More
Immunovia AB significantly increased the accuracy of its test for the early detection of pancreatic cancer, achieving an 85% sensitivity and a specificity of 98%. Read More
The U.S. Medicare program’s final rule for fiscal year 2025 inpatient care retains several controversial proposals, but some device makers fared well in their new technology add-on payment (NTAP) applications, including Dublin-based Medtronic plc, which won NTAP payments for two devices. Read More
The U.S. FDA’s device center is working to refine its regulation of artificial intelligence algorithms, but the agency is recommending that industry be more forward-thinking in a blog that urges device makers to fully adopt a life cycle management mindset for these systems. Read More
The med-tech industry has seen a significant boost in fundraising, amassing $16.13 billion in the first seven months of this year, a nearly 38% increase from the $11.73 billion raised during the same period last year. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Carlsmed, Delcath, Exact Science, Invitae, Labcorp, Medical Microinstruments, MMI, Twinstrand, Virtual Incision. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Advanced Sterilization Products, Pentax Medical. Read More
