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Home » Newsletters » BioWorld MedTech

BioWorld MedTech

June 14, 2023

View Archived Issues
Surmodics Inc.’s Pounce

FDA 510(k) clears the way for Surmodics to Pounce on expanded thrombectomy opportunity

Surmodics Inc. is poised to jump on the market for below the knee thrombectomy now that its Pounce platform with a low-profile (LP) model has FDA 510(k) clearance. The system can now effectively clear organized clots from vessels as small as 2 mm in diameter. The Pounce LP expands the Eden Prairie, Minn.-based company’s “grab-go-flow” platform. In its first iteration, Pounce enabled removal of thrombi and emboli in peripheral arteries 3.5 mm to 6 mm in diameter. Read More

US House committee recommends FDA move on rulemaking for LDT regulation

The June 14 hearing of the House Appropriations Committee was focused largely on spending levels for the Department of Agriculture, but there was also some concern over the proposed spending levels for the FDA. One of the more conspicuous features of the legislative report is the recommendation that the FDA finalize guidance or rulemaking for risk-based regulation of lab-developed tests (LDTs), a clear departure from the stance taken by Congress for a number of years. Read More
Boston Scientific's Ranger drug-coated balloon

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

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. Read More
Seracam, Serac's portable gamma imaging system

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. Read More
AI silhouette

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

Negotiations over the text of the EU’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 other groups, 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 diminish the utility of AI software in health care. Read More

BioWorld MedTech reader feedback needed

Please take a few minutes to fill out this short survey to help us provide you with the best possible source of news. Customer feedback is critical so that we can make BioWorld MedTech an even more useful and valuable component of your daily workflow. We want to continue to evolve to serve you. The survey should take less than 5 minutes. You can click through to the question here. Read More

Appointments and advancements for June 14, 2023

New hires and promotions in the med-tech industry, including: Agendia, Iylon Precision Oncology, Personalis, Precisemdx. Read More

Financings for June 14, 2023

Med-tech firms raising money in public or private financings, including: Radnet, Tenon Medical. Read More

In the clinic for June 14, 2023

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Avenda. Read More

Other news to note for June 14, 2023

Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Micare Pth, Mio-Guard, Nanovibronix, Ontrac MD, Pacbio, Redpoint Medical, Seegene, Tnacity, Treace, Veradigm, Werfen. Read More

Regulatory actions for June 14, 2023

Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Apyx, Futura, Gencurix. Read More

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