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Alcyone Lifesciences

Alcyone wins breakthrough device status for delivery device

March 11, 2019 By Sarah Faulkner

Alcyone Lifesciences said today that its ThecaFlex DRx system won breakthrough device status from the FDA. The Lowell, Mass.-based company’s system features an implantable subcutaneous port and intrathecal catheter used to provide access for cerebrospinal fluid aspiration and infusion of therapies. Get the full story at our sister site, Drug Delivery Business News.

Filed Under: Drug-Device Combinations, Food & Drug Administration (FDA), Pharmaceutical, Regulatory/Compliance Tagged With: Alcyone Lifesciences

Alcyone Lifesciences wins FDA nod for Alivio hydrocephalus shunt flusher

November 16, 2017 By Fink Densford

Alcyone Lifesciences said yesterday it won FDA 510(k) clearance for its Alivio ventricular catheter and flusher system designed for treating hydrocephalus. The newly cleared Alivio device is designed for the non-invasive retrograde flushing of the ventricular catheter to unblock occluded inlet holes or open a relief membrane to restore or increase cerebrospinal fluid flow in […]

Filed Under: 510(k), Food & Drug Administration (FDA), Neurological, Regulatory/Compliance Tagged With: Alcyone Lifesciences

7 medtech stories we missed this week: Oct. 27, 2017

October 27, 2017 By Danielle Kirsh

From RadiaDyne’s FDA expansion to NuVasive launching its new implants, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. FDA expands indications for RadiaDyne’s OARtrac dose monitor RadiaDyne announced in an Oct. 24 press release that it has received additional FDA clearance for its upcoming OARtrac. The OARtrac allows […]

Filed Under: Catheters, Dental, Diagnostics, Food & Drug Administration (FDA), Imaging, Implants, Neurological, Research & Development Tagged With: Alcyone Lifesciences, Implanet, MedTech, Nuvasive, Ortek Therapeutics, radiadyne, Tau Consortium, Varian Medical Systems

Alcyone Lifesciences seeks FDA nod for ReFlow neuro cath

August 2, 2016 By Mark Hollmer

Alcyone Lifesciences is seeking formal commercial approval for its device to treat fluid buildup in the brain, following its successful implant in 4 patients in an ongoing study at Boston Children’s Hospital. The Lowell, Mass.-based company said that its decision to file a 510(k) premarket notification with the FDA seeking a regulatory sign-off for its ReFlow […]

Filed Under: Catheters, Food & Drug Administration (FDA), Neurological, Regulatory/Compliance Tagged With: Alcyone Lifesciences

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