The FDA has classified Cordis‘ recall of its Precise Pro Rx carotid system as Class I, the most serious kind of recall. Cordis in February recalled certain lots of its Precise Pro RX carotid stent systems because of a risk of separation of the atraumatic distal tip of the sheathed delivery system in patients. Get the full story at our sister … [Read more...] about FDA says Cordis carotid artery stent recall is serious
Components
FDA grants IDE approval for Cerus Endovascular’s Contour Neurovascular System clinical study
Cerus Endovascular announced today that it received FDA investigational device exemption for a trial for its Contour Neurovascular System. Fremont, Calif.-based Cerus’ Contour Neurovascular System is designed to treat intracranial aneurysms. It is made of fine mesh braid to target the neck of the aneurysm away from the vulnerable dome. Get the … [Read more...] about FDA grants IDE approval for Cerus Endovascular’s Contour Neurovascular System clinical study
Endologix acquires PQ Bypass
Endologix today announced that it has completed its acquisition of PQ Bypass for an undisclosed amount. PQ Bypass makes the Detour platform that is designed for percutaneous femoral-popliteal bypass, which has been designated as a breakthrough device by the FDA. The Detour system has the company’s Torus stent graft and the PQ crossing device. … [Read more...] about Endologix acquires PQ Bypass
Qosina adds single-use bioprocessing devices
Qosina this week launched its product line for the single-use bioprocess industry. The new product line includes tube-to-tube bard connectors, luer fittings, check valves, tubing pinch clamps, tubing, steam thru connectors and more. “Qosina has been a trusted supplier for over 40 years and has worked with some of the best-known brands,” … [Read more...] about Qosina adds single-use bioprocessing devices
Erbe Elektromedizin to acquire Maxer Endoscopy
Erbe Elektromedizin announced today that it is set to acquire Maxer Endoscopy for an undisclosed amount. Teubingen, Germany–based Erbe Elektromedizin develops, manufactures and distributes surgical instruments and devices in almost all specialist areas. Combined with other Erbe technologies, the surgical instruments are based on … [Read more...] about Erbe Elektromedizin to acquire Maxer Endoscopy
Marposs debuts laser measuring system for tubing
Marposs this week launched its Aeroel Extuline laser measuring system for diameter control and flaw detection of opaque or transparent extruded products. The measuring system is designed for products such as medical tubing, glass pipes, sections, and electric cables. It features an on-line diameter measurement and automatically prevents the … [Read more...] about Marposs debuts laser measuring system for tubing
Investment group acquires Wytech Industries
Wire and tubing manufacturer Wytech Industries has been acquired by private equity firm Vance Street Capital. Rahway, N.J.-based Wytech was founded in 1975 and manufactures specialty core wires and related components for the interventional medical markets. Its customers include the leading medical device OEMs and contract manufacturers focused … [Read more...] about Investment group acquires Wytech Industries
6 ways the right tubing supplier can improve product development
Partnering with a vertically integrated manufacturer can help engineers optimize designs, improve manufacturability and accelerate new product development. Michael Holt, Integer (Image courtesy of Integer) Medtech design engineers face extraordinary opportunities and challenges created by rapidly advancing clinical markets. To … [Read more...] about 6 ways the right tubing supplier can improve product development
Heraeus Medical Components acquires Pulse Systems
Heraeus Medical Components announced this week that it has acquired Pulse Systems, a precision laser processor and manufacturer of nitinol and other metal-based implants and delivery systems. A key reason for the acquisition is the increasing importance of vascular access and delivery systems to enable new therapies, according to Peter Reimer, … [Read more...] about Heraeus Medical Components acquires Pulse Systems
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
