Surmodics is poised to jump on the market for below the knee thrombectomy now that its Pounce platform with a low-profile model has FDA 510(k) clearance. The system can now effectively clear organized clots from vessels as small as 2 mm in diameter.

US House committee provides FDA with flat taxpayer authorities for fiscal 2024

The June 14 hearing of the U.S. House Appropriations Committee was focused largely on spending levels for the Department of Agriculture, but there was some concern over the proposed spending levels for the FDA as well. The committee initially floated a spending level for the FDA of $3.5 billion in direct appropriations for the FDA and a total of $6.6 billion when user fees are added, but some programs at the FDA may suffer from the flat appropriations levels, such as the effort to upgrade the agency’s IT infrastructure.

Boston Sci’s Ranger DCB shows ‘best ever’ 3-year primary patency and 4-year freedom TLR rate

Boston Scientific Corp. said that three-year primary patency and the four-year freedom from target lesion revascularization (TLR) rate for patients treated with the Ranger drug-coated balloon (DCB), in the RANGER II superficial femoral artery (SFA) study, are the best ever reported data for randomized trials using DCBs. The results which were presented at the recent LINC Congress, in Leipzig, Germany, adds continued confidence that the Ranger DCB is a safe and effective device over four years, Michael Jaff, chief medical officer at Boston Scientific, told BioWorld.

Serac begins studies for portable gamma imaging system

Gamma imaging is about to move out of the centralized nuclear medicine department and to the point of care, with the start of a U.S. study of a portable device Seracam, under development by Serac Imaging Systems Ltd. The study, at Ohio State University, will compare the performance of Seracam to its larger, fixed, counterpart in imaging the same patients, on the same day. There also will be feedback from clinicians on the usability of the device, the quality of the display and the ease of interpreting the images.

Medtech Europe, others voice concerns regarding EU’s Artificial Intelligence Act

Negotiations over the text of the European Union’s Artificial Intelligence Act (AI Act) are drawing to a close, but stakeholders are concerned about several key aspects of the legislation, such as how the term “artificial intelligence” is defined. However, Medtech Europe and others, including medical professional societies, are also concerned that the provisions for governance of data would seem to exclude real-world data as a source of evidence, an oversight they say will greatly diminish the utility of AI software in health care.

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