Flowonix Medical has won FDA approval for its Prometra II 40 ml programmable pump and its associated software for intrathecal infusion. The pump has expanded reservoir size options that include 20 ml and 40ml pumps, along with the claim of 10-year battery life at average flow rates. Flowonix said in a news release yesterday that […]
Flowonix Medical
Flowonix wins FDA nod for infusion pump software
Flowonix Medical said yesterday that it won FDA approval to market the updated software used to program the company’s Prometra infusion system. The clinician programmer software, which Flowonix plans to launch in February, includes automatic calculations and increased dosing flexibility during bridge bolusing, according to the company. Get the full story at our sister site, Drug […]
Fifth patient treated in Flowonix, Cerebral Therapeutics epilepsy study
Flowonix Medical and Cerebral Therapeutics said today that the fifth patient was successfully treated in its Address trial, which features a micro-infusion device controlling drug delivery to a particular part of the brain in patients with medically refractory epilepsy. The study is the first of its kind, according to the companies. The Address trial is designed to evaluate […]
Prometra micro-infusion device used to deliver meds directly to brain in epilepsy trial
Flowonix Medical and Cerebral Therapeutics said today that the 1st patients were implanted with the Prometra II programmable infusion system in a clinical trial evaluating the pump in patients with refractory epilepsy. The Address trial marks the 1st time a programmable, implantable pump has been used to deliver medication, in this case valproate, directly to […]
Flowonix warns on MRI risk for Promectra implantable pump
Flowonix Medical issued an urgent field safety notice late last month warning of risks associated with magnetic resonance imaging procedures for patients with its Prometra implantable pump, which include possible drug overdoses. Flowonix said it has “become aware” of issues arising from patients undergoing MRI procedures without following labelled MR conditions. “Strong magnetic fields, such […]
Flowonix, Cerebral Therapeutics ink deal to dev direct-to-brain drug delivery system
Flowonix Medical and Cerebral Therapeutics said today they signed a deal to develop an implanted brain-targeted drug delivery system to treat neurological diseases. The device is being designed to deliver microdoses of medication directly to the brain, bypassing the blood-brain barrier and reaching specifically targeted regions for more effective dosing, Mount Olive, N.J.-based Flowonix said. “Neurological […]
Flowonix wins FDA nod for drug pump
Flowonix Medical said today it won FDA 510(k) clearance for its Patient Therapy Controller designed to interface with intrathecal infusion devices. The PTC is a small hand-held device with a touch screen that allows patients to initiate bolus delivery of medication from implanted pumps, according to the Mount Olive, N.J.-based company. The device is designed […]
