The underwriter of an initial public offering by Hancock Jaffe Laboratories (NSDQ:HJLI) this week exercised in full its over-allotment option, taking the gross proceeds from the flotation to nearly $9 million. The IPO, which priced on the last day of May, initially brought in $7.5 million for Irvine, Calif.-based Hancock Jaffe, which makes bioprosthetic implants designed to treat chronic […]
Medtronic wins FDA nod for new lengths of drug-coated balloon
Medtronic (NYSE:MDT) said today that it won FDA approval for 200mm and 250mm lengths of its In.Pact Admiral drug-coated balloon. The newly-approved lengths are designed to treat patients with longer, more complex superficial femoral artery lesions, according to the medtech giant. Get the full story at our sister site, Drug Delivery Business News.
Avinger launches post-market study comparing OCT to IVUS in PAD treatments
Avinger (NSDQ:AVGR) said today it launched a post-market study comparing optical coherence tomography to intravascular ultrasound as used during interventions in the peripheral arteries. The Redwood City, Calif.-based company’s Lumivascular tech, including its Pantheris image-guided atherectomy device and Ocelot image-guided chronic total occlusion crossing catheters, use OCT for real-time intravascular imaging during interventions to treat peripheral […]
FDA panel backs Cardinal Health’s Incraft stent graft
Cardinal Health (NYSE:CAH) said this week that the FDA Circulatory System Devices Panel of its Medical Devices Advisory Committee issued a favorable recommendation on the premarket approval application for the company’s Incraft abdominal aortic aneurysm stent graft system. The panel voted 11 to 4 in favor of the Incraft system, which is designed as an advanced […]
Terumo’s MicroVention wins expanded FDA indications for Sofia cath
Terumo (OTC:TRUMY;TYO:4543) subsidiary MicroVention said today it won FDA clearance for a new clinical indication for its Sofia catheter designed for intracranial access, now cleared for contact aspiration procedures to treat acute ischemic stroke. The company said it won CE Mark approval in the European Union for the aspiration in 2015, and that the device has been used […]
Fresenius Medical Care, Humacyte ink $150m strategic partnership deal
Fresenius Medical Care (NYSE:FMS; ETR:FRE) said today it inked a $150 million strategic partnership deal with Humacyte through which Fresenius will gain exclusive rights to commercialize Humacyte’s Humacyl bioengineered blood vessel technology. Research Triangle Park, N.C.-based Humacyte is exploring the use of its Humacyl human acellular vessel as a conduit for hemodialysis in patients with end-stage renal […]
Corindus wins Japanese PMDA clearance for CorPath GRX platform
Corindus Vascular Robotics (OTC:CVRS) said today it won clearance from Japan’s Pharmaceutical and Medical Device Agency for its CorPath GRX robotic surgical device. The CorPath GRX vascular robotics platform is designed to assist cardiologists in performing percutaneous coronary interventions, including angioplasty and stent placement, Corindus said. “I look forward to offering CorPath GRX to my patients […]
Keystone Heart launches new TriGuard embolic protection study
Keystone Heart said today it launched the second phase of its Reflect trial evaluating the safety and efficacy of its third-generation TriGuard cerebral embolic protection device. In the trial, investigators will explore the use of the TriGuard 3 and its ability to protect a patient’s brain from emboli during transcatheter aortic valve replacement procedures, the […]
Report: Extra insights, but no clear-cut answers from TAVR embolic protection studies
Data from two new studies has provided extra insights, but no clear-cut solution for predicting stroke and which patients should receive embolic protection devices during transcatheter aortic valve replacement procedures, according to a new Medscape report. Results from a meta-analysis of 1,285 patients indicated that the use of embolic protection devices during TAVR procedures did […]
Terumo’s MicroVention wins PMA for LVIS neuro stents
Terumo (OTC:TRUMY;TYO:4543) subsidiary MicroVention said today that it won pre-market approval from the FDA for a line of neurovascular stents. Aliso Viejo, Calif.-based MicroVention said the federal safety watchdog approved its low-profile visualized intraluminal support devices for stent-assisted coil embolization of intracranial aneurysms. Previously approved under a humanitarian device exemption, the LVIS and LVIS Jr. […]
Preceptive Navigation wins $3m NIH grant for Vu-Path ultrasound nav device
Medtech company Perceptive Navigation said yesterday it won a $3 million Phase IIB Small Business Innovation Research grant from the National Heart, Lung and Blood Institute to support its Vu-Path ultrasound system. The Baltimore-based company’s Vu-path system is designed to aid in minimally-invasive, point-of-care procedures. The system is a miniaturized, forward-viewing ultrasound probe combined with […]
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