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Flowonix Medical

FDA approves Flowonix’s Prometra II programmable pump

October 25, 2019 By Sean Whooley

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 […]

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA) Tagged With: Flowonix Medical

Flowonix wins FDA nod for infusion pump software

February 6, 2019 By Sarah Faulkner

Flowonix 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. Flowonix’s programmable Prometra pump is indicated for intrathecal […]

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Pharmaceuticals, Regulatory/Compliance Tagged With: Flowonix, Flowonix Medical

Fifth patient treated in Flowonix, Cerebral Therapeutics epilepsy study

October 3, 2017 By Sarah Faulkner

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 […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Neurological, Pharmaceuticals Tagged With: Cerebral Therapeutics, Flowonix Medical

Prometra micro-infusion device used to deliver meds directly to brain in epilepsy trial

March 15, 2017 By Sarah Faulkner

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 […]

Filed Under: Clinical Trials, Featured, Food & Drug Administration (FDA), Neurological, Wall Street Beat Tagged With: Cerebral Therapeutics, Flowonix Medical

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