Private equity firm Arcline Investment Management announced that it has acquired a controlling stake in Syneo from Rockwood Equity. Syneo is a vertically-integrated machine, tooling and services company focused on the interventional medtech industry as well as specialty “press-fit” printed circuit board applications. Syneo has thousands of … [Read more...] about Syneo sold to investment firm
Catheters
Philips touts post-stent imaging study results
Royal Philips (NYSE:PHG) announced today that one-year results of its Define PCI study that reported improved outcomes and less recurrent angina. The Define PCI study assessed the level of residual ischemia found in patients following a percutaneous coronary intervention (PCI) using a blinded instant wave-free ratio (iFR) pullback measurement, … [Read more...] about Philips touts post-stent imaging study results
J&J wins FDA approval for ablation catheter
Johnson & Johnson (NYSE:JNJ) recently announced that its Biosense Webster business has secured FDA approval for its Thermocool SmartTouch SF ablation catheter. The Thermocool SmartTouch received approval for the treatment of persistent atrial fibrillation, J&J announced yesterday. The approval came after results from the 381-patient, … [Read more...] about J&J wins FDA approval for ablation catheter
NanoVibronix device gains FDA nod for import to U.S.
NanoVibronix (NSDQ:NAOV) announced that it received FDA enforcement discretion for the U.S. distribution of the UroShield device. According to a news release, the FDA exercised its enforcement discretion, giving Elmsford, N.Y.-based NanoVibronix’s UroShield an intended use code (IUC), clearing the way for the import of the system to the U.S. … [Read more...] about NanoVibronix device gains FDA nod for import to U.S.
Boston Scientific warns on Hurricane RX biliary balloon dilatation catheter
Boston Scientific (NYSE:BSX) said it is recalling specific lots/batches of its Hurricane RX biliary balloon dilation catheters. Marlborough, Mass.-based Boston Scientific, which issued a warning letter from its international location in France, said the removal comes in response to an increase in complaints of the RX tunnel component (black … [Read more...] about Boston Scientific warns on Hurricane RX biliary balloon dilatation catheter
BioProtect closes $25M Series D equity financing round
BioProtect this week announced it closed a $25 million Series D equity financing round. Peregrine Ventures and an unnamed strategic investor completed the financing round that was led by Almeida Ventures and Vincent Tchenguiz, chairperson of Consensus Business Group. KB Investments of South Korea and Triventures also participated in the … [Read more...] about BioProtect closes $25M Series D equity financing round
Acutus Medical 3D imaging and mapping catheter wins FDA clearance
Acutus medical recently won FDA 510(k) clearance of its AcQMap 3D imaging and mapping catheter. The mapping catheter builds on its predecessor and improves handling and deliverability. It combines 48 ultrasound transducers responsible for creating anatomical geometry and 48 engineered electrodes that enable electrical activation patterns to … [Read more...] about Acutus Medical 3D imaging and mapping catheter wins FDA clearance
Prytime Medical launches aortic occlusion catheter
Prytime Medical recently launched its aortic occlusion catheter ER-REBOA Plus Catheter. The resuscitative endovascular balloon occlusion of the aorta (REBOA) catheter is designed for controlling massive non-compressible hemorrhage. “ER-REBOA Plus represents the evolution of REBOA based on experience and input from civilian trauma surgeons,” … [Read more...] about Prytime Medical launches aortic occlusion catheter
FDA clears Avinger image-guided CTO crossing system
Avinger this week announced it received FDA 510(k) clearance for its Ocelaris image-guided chronic total occlusion crossing system. The device will be marketed under the brand name TigerEye and will provide real-time imaging from inside the vessel during CTO-crossing procedures. “We are excited to receive U.S. pre-marketing clearance for … [Read more...] about FDA clears Avinger image-guided CTO crossing system
Johnson & Johnson’s Cerenovus launches new clot removal devices to treat stroke
Johnson & Johnson's Cerenovus recently announced it has launched its new stroke solutions platform that includes three devices for clot removal procedures. The three devices are designed to aid physicians in performing mechanical thrombectomy procedures. The devices include the Cerebase DA Guide Sheath, Cerenovus Large Bore Catheter and … [Read more...] about Johnson & Johnson’s Cerenovus launches new clot removal devices to treat stroke
