Potrero Medical today announced that it has appointed Steve Okland as chief commercial officer. Prior to joining the sensory integrated foley catheter company, Okland has served on the leadership teams at Second Sight Medical and DryShield. He has also held sales and marketing leadership roles at Miramar Labs, Medivance, Spectranetics and Boston … [Read more...] about Potrero Medical appoints medtech vet Steve Okland as chief commercial officer
Catheters
FDA clears expanded indications for BD’s Rotarex atherectomy system
BD this week announced that it has received FDA 510(k) clearance for expanded indications for its Rotarex atherectomy system. Franklin Lakes, N.J.-based BD designed the Rotarex as a rotational excision device that removes and aspirates varying lesion morphologies in the peripheral arteries. "The Rotarex atherectomy system is quick and … [Read more...] about FDA clears expanded indications for BD’s Rotarex atherectomy system
Raumedic plans U.S. headquarters expansion
Raumedic today said it intends to expand its clean room manufacturing facilities at its U.S. headquarters in Mills River, North Carolina. The new clean room is expected to be completed by February 2022 and used for new product lines. The Helmbrechts, Germany-based medical device component developer and manufacturer built its existing … [Read more...] about Raumedic plans U.S. headquarters expansion
Medtronic wins CE mark approval for radial artery access portfolio
Medtronic today said it has received CE mark approval for its radial artery access portfolio. The radial artery access devices include the Rist 079 radial access guide catheter and the Rist radial access selective catheter. Medtronic designed the Rist 079 guide catheter to access the neuro vasculature through the radial artery instead of … [Read more...] about Medtronic wins CE mark approval for radial artery access portfolio
FDA approves Abbott’s next-gen Epic Plus heart valves
Abbott (NYSE:ABT) announced today that it received FDA approval for its Epic Plus and Epic Plus Supra stented tissue valves. The approval offers improved therapy options for people with aortic or mitral valve disease through the next-generation devices that build off of Abbott’s Epic surgical valve platform, according to a news release. Get the … [Read more...] about FDA approves Abbott’s next-gen Epic Plus heart valves
Nuwellis wins CE mark for 24-hour blood circuit set for use with Aquadex SmartFlow
Nuwellis (NSDQ:NUWE) announced today that it received CE mark approval for its 24-hour blood circuit set for use with the Aquadex SmartFlow. Eden Prairie, Minnesota-based Nuwellis — formerly CHF Solutions — can now market the 24-hour blood circuit set (UF 500-24 Hour) in the European Union and other locations that recognize the CE mark. Get the … [Read more...] about Nuwellis wins CE mark for 24-hour blood circuit set for use with Aquadex SmartFlow
Boston Scientific to acquire Devoro Medical and its Wolf thrombectomy platform
Boston Scientific today announced that it has entered an agreement to acquire Devoro Medical for more than $269 million. Marlborough, Massachusetts-based Boston Scientific has been a strategic investor in Devoro Medical since 2019, according to the company. It has an equity stake of approximately 16%. The transaction will consist of an upfront … [Read more...] about Boston Scientific to acquire Devoro Medical and its Wolf thrombectomy platform
Medtronic’s Pipeline Flex problems expand
The FDA today issued a notice confirming a Class I recall of the Pipeline Flex embolization device from Medtronic (NYSE:MDT). Several models of the Pipeline Flex embolization device and Pipeline Flex embolization device with Shield Technology were affected, with 8,825 devices recalled in the U.S., having been distributed between April 18, 2019, … [Read more...] about Medtronic’s Pipeline Flex problems expand
InTRAvent wins FDA 510(k) clearance for Solopass bedside neuro-navigation device
InTRAvent has announced FDA 510(k) clearance of its Solopass system for assisting frontal placement of intraventricular catheters deep within the brain. The Hershey, Pennsylvania-based company said yesterday that it designed the device with 2D and 3D ultrasound imaging, artificial intelligence and trajectory guidance for intraprocedural … [Read more...] about InTRAvent wins FDA 510(k) clearance for Solopass bedside neuro-navigation device
Nectero Medical completes $19.5M Series C funding round led by Boston Scientific
Nectero Medical announced today that it closed a $19.5 million Series C funding round led by new investor Boston Scientific (NYSE:BSX). Tempe, Arizona-based Nectero Medical said in a news release that proceeds will be put toward its in vivo and clinical trials for the development of a treatment platform designed to stabilize small- to mid-sized … [Read more...] about Nectero Medical completes $19.5M Series C funding round led by Boston Scientific