U.S. federal enforcement authorities rang up some significant settlements under the False Claims Act in the first half of 2024, amounting to a record $1 billion in total settlements, according to a report by the law firm of Gibson, Dunn & Crutcher LLP.
Haemonetics Corp. received CE mark certification for the Savvywire pre-shaped pressure guidewire, a sensor-guided three-in-one guidewire for transcatheter aortic valve implantation. The solution, which is expected to enhance TAVI procedures and improve patient outcomes, is already being used in procedures in European countries.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Advanced Sterilization Products, Pentax Medical.
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.
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.
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.
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.
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