Cardio Flow this week won FDA 510(k) clearance for its FreedomFlow peripheral guidewire and announced the first commercial case using the device in the U.S. St. Paul, Minnesota–based Cardio Flow designed FreedomFlow to provide exceptional support for diagnostic and therapeutic devices in treating plaque blockages in arteries above and below the … [Read more...] about Cardio Flow’s FreedomFlow guidewire wins FDA clearance
Implants
18 of the world’s most innovative medical technologies
Judges this week are voting for the most innovative medical technologies among the nominees for the 2022 Prix Galien International Awards. The Prix Galien International Awards highlight the most innovative technologies in the life sciences industry. The New York-based Galien Foundation presents the international award to eligible nominees that … [Read more...] about 18 of the world’s most innovative medical technologies
First patient in the world implanted with Abiomed Impella BTR heart pump
Abiomed (Nasdaq:ABMD) today announced the first patient in the world was successfully treated with its Impella Bridge-to-Recovery (BTR) as part of an early feasibility study. The first implant was performed by Dr. Duc Thinh Pham and Dr. Jane Wilcox at Northwestern Medicine Bluhm Cardiovascular Institute in Chicago. Impella BTR is a forward … [Read more...] about First patient in the world implanted with Abiomed Impella BTR heart pump
Catheter delivery could enable better brain implants: Synchron’s neuroscience chief explains how
Synchron's catheter delivery could make brain-computer interface technology simpler, safer and more accessible than the leading alternative: open-brain surgery. Officials at Synchron — developer of the catheter-delivered Stentrode brain-computer interface (BCI) implant — believe they're the only BCI company tapping into blood vessels to capture … [Read more...] about Catheter delivery could enable better brain implants: Synchron’s neuroscience chief explains how
Cook Medical wins FDA breakthrough designation for Thoraco+ endovascular system
Cook Medical today announced that its Zenith Thoraco+ endovascular system received FDA breakthrough device designation. Thoraco+ is the company's next-generation endovascular graft that is indicated for the endovascular treatment of patients with thoracoabdominal aortic aneurysms. “We are excited to receive an FDA breakthrough device … [Read more...] about Cook Medical wins FDA breakthrough designation for Thoraco+ endovascular system
FDA approves Edwards Lifesciences’ tissue valve replacement for heart’s mitral position
Edwards Lifesciences (NYSE:EW) announced today that the FDA approved its Mitris Resilia tissue valve replacement system. Irvine, California-based Edwards designed the Mitris Resilia valve with a saddle-shaped sewing cuff that mimics the asymmetric shape of the native mitral valve. It features a low-profile frame for avoiding obstruction of the … [Read more...] about FDA approves Edwards Lifesciences’ tissue valve replacement for heart’s mitral position
4C Medical closes $35M Series C financing round, appoints CEO
4C Medical Technologies today announced that it completed a $35.4 million Series C financing round and appointed Saravana Kumar as president and CEO. The preferred stock financing round was led by MicroPort CardioFlow Medtech. As part of the closing, Kumar was appointed to lead the company after having served as interim president and CEO since … [Read more...] about 4C Medical closes $35M Series C financing round, appoints CEO
Synchron says study shows safety of its brain-computer interface implant
Four ALS patients with a Synchron Stentrode brain implant had no serious adverse events one year after their procedure, which allowed the paralyzed patients to control a computer for online shopping, banking and text communication without using their hands or voice for input. New York-based Synchron said this study demonstrated the safety of its … [Read more...] about Synchron says study shows safety of its brain-computer interface implant
Confluent Medical Technologies closes majority investment from TPG Capital
Confluent Medical Technologies announced that it closed a majority investment from TPG Capital following TPG’s agreement to acquire a majority stake in the company. Last month, Confluent Medical confirmed that TPG Capital signed a definitive agreement to acquire a majority stake in the company, joining existing investor Ampersand Capital … [Read more...] about Confluent Medical Technologies closes majority investment from TPG Capital
AtHeart Medical wins FDA approval for second phase of ASD occluder IDE study
AtHeart Medical recently announced that it received FDA approval to commence the second phase of its Ascent ASD investigational device exemption pivotal trial. Switzerland-based AtHeart Medical is evaluating the safety and efficacy of the reSept atrial septal defects (ASD) occluder in a prospective, single-arm study. The reSept device is … [Read more...] about AtHeart Medical wins FDA approval for second phase of ASD occluder IDE study
