Roivios announced today that it received FDA breakthrough device designation for its JuxtaFlow renal assist device (RAD). The Bahamas-based medical device company designed JuxtaFlow to improve treatments for patients facing kidney disease during … [Read More...] about Roivios wins FDA breakthrough nod for renal assist device
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Roivios wins FDA breakthrough nod for renal assist device
By Sean Whooley
Roivios announced today that it received FDA breakthrough device designation for its JuxtaFlow renal assist device (RAD). The Bahamas-based medical device company designed JuxtaFlow to improve treatments for patients facing kidney disease during … [Read More...] about Roivios wins FDA breakthrough nod for renal assist device
Fresenius Medical Care recalls more than 2 million catheter components
By Sean Whooley
The FDA says a recall of Fresenius Medical Care catheter extension sets and luer lock adapters is Class I, the most serious kind. Fresenius Medical Care initiated the recall of a number of its Stay-Safe luer lock adapters and catheter extensions … [Read More...] about Fresenius Medical Care recalls more than 2 million catheter components
Thermedical completes feasibility study to use SERF with PFA
By Sean Whooley
Thermedical announced today that it completed a feasibility study using pulsed field ablation in combination with its SERF ablation system. Weston, Massachusetts–based Thermedical designed its SERF system and Durablate catheter to work with PFA to … [Read More...] about Thermedical completes feasibility study to use SERF with PFA
FDA clears computer-assisted thrombectomy system from Penumbra
By Sean Whooley
Penumbra (NYSE:PEN) announced today that it received FDA clearance for and began the launch of its Lightning Flash 2.0 CAVT system. Lightning Flash 2.0 represents the next generation of the company's computer-assisted vacuum thrombectomy (CAVT) … [Read More...] about FDA clears computer-assisted thrombectomy system from Penumbra
Zeus names first chief technology officer
Zeus today announced it named Suresh Sainath as its new chief technology officer, effective immediately. The chief technology officer position is newly created, and Sainath will lead the Orangeburg, S.C.-based polymer extrusion and catheter … [Read More...] about Zeus names first chief technology officer
Concept Medical enrolls first patient in drug-coated balloon study
By Sean Whooley
Concept Medical announced today that it commenced the FDA investigational device exemption (IDE) study of its MagicTouch system. MagicTouch, a sirolimus drug-coated balloon (DCB), treats in-stent restenosis (ISR) in coronary artery disease (CAD). … [Read More...] about Concept Medical enrolls first patient in drug-coated balloon study
The top catheter-based innovation news stories of 2024 — so far
Catheter innovations have had a remarkable year so far, with many receiving regulatory approval as they prepare to enter the market. The pulsed field ablation market heated up in 2023 and continues to make waves this year with more companies … [Read More...] about The top catheter-based innovation news stories of 2024 — so far