Aptar Pharma said this week that its Bidose nasal spray device won FDA approval for use with a breakthrough depression therapy. The Crystal Lake, Ill.-based company’s Bidose tech enables two-shot nasal drug delivery. Aptar touted its manufacturing facility in Congers, NY, which supports the manufacture of nasal and injectable drug delivery systems. Get the full story […]
Cala Health licenses MGH-developed neuromod tech
Cala Health said this week it inked a deal to license technology from Partners Healthcare and its affiliate Massachusetts General Hospital intended to improve the company’s non-invasive neuromodulation platform for investigating and treating chronic diseases. The licensed technology was developed from research on transcutaneous vagus nerve stimulation and respiratory-gated vagal afferent nerve stimulation at a […]
FDA approves J&J’s nasal spray for treatment-resistant depression
The FDA has approved Johnson & Johnson‘s (NYSE:JNJ) esketamine nasal spray for people living with treatment-resistant depression. The company’s product, Spravato, is an intranasal formulation of ketamine – a horse tranquilizer that is also known as Special K. The drug won support for approval from an FDA advisory committee earlier this year. Get the full story at […]
IschemaView launches Rapid Angio neuroimaging system
Medical imaging dev IschemaView said yesterday that it launched its Rapid Angio neuroimaging system designed for use in the angiography suite. The Menlo Park, Calif.-based company said that it partnered with Siemens (NYSE:SI) to integrate the Rapid software with Siemens’ SyngoDynaCT multiphase system for the newly launched imaging solution. Siemens’ SyngoDyna CT Multiphase is a 3D image acquisition […]
Abbott wins $35m Defense contract for TBI assay
Abbott (NYSE:ABT) landed a contract with the U.S. Defense Dept. to develop a diagnostic assay to detect traumatic brain injuries, the Pentagon said yesterday. The Chicago-area healthcare giant was the lone bidder for the $35.2 million fixed-price contract, with an estimated completion date of Aug. 31, 2022. The deal also comes with an immediate $12 […]
Penumbra revenue up but earnings down in Q4
Penumbra (NYSE:PEN) saw its revenue jump more than 25% year-over-year in the fourth quarter, but earnings were down for the Alameda, Calif.–based maker of devices to treat neuro and peripheral vascular conditions. Alameda, Calif.-based Penumbra’s stock is down about $15.57 per share, or 10.6%, to $131.25 as of midday trading. The company reported yesterday evening […]
Insightec wins expanded Medicare coverage for essential tremor treatment
Incisionless neurosurgery company Insightec said it has won Medicare coverage for its Neuravive MR-guided focused ultrasound device in 13 more states, effective April 1, 2019. Health insurance administrator Noridian extended coverage to Medicare recipients in Alaska, Arizona, California, Hawaii, Idaho, Montana, Nevada, North Dakota, Oregon, South Dakota, Utah, Washington, and Wyoming. Insightec’s Neuravive technology is designed to treat essential tremor […]
Neuroelectrics touts FDA IDE Starstim epilepsy treatment study data
Medical device dev Neuroelectrics today released results from an FDA investigational device exemption trial of its Starstim device intended to treat patients with drug resistant epilepsy, touting a significant reduction in seizure frequency. The Starstim device from the Cambridge, Mass.-based company provides transcranial current stimulation, delivering mild electrical currents to the specific areas of the […]
Alphatec wins FDA nod for SafeOp neuromonitoring system
Alphatec (NSDQ:ATEC) said today that it won FDA 510(k) clearance for its SafeOp neuromonitoring system, now cleared for use in real-time intraoperative nerve location and health assessment. The clearance expands the indications for the next-gen system to include more advanced algorithms for electromyography, which is used to test nerves for location, proximity and conduction. The system […]
Ctrl-Labs raises $28m for neural interface tech
Neural interface developer Ctrl-Labs has raised $28 million in a new round of equity financing, joined by both Google and Amazon, to support its non-invasive electromyography tech designed to translate neural signals into digital input. The round was led by Google‘s (NSDQ:GOOG) venture arm, GV, and joined by the Amazon Alexa Fund, Lux Capital, Spark […]
LivaNova touts CMS trial clearance for vagus nerve depression treatment system
LivaNova (NSDQ:LIVN) said on Wednesday that the U.S. Centers for Medicare & Medicaid Services finalized a National Coverage Decision for LivaNova’s Vagus Nerve Stimulation Therapy for treating treatment-resistant depression. The London-based company said that the modified NCD will enable Medicare coverage for VNS therapy through the Coverage with Evidence Development framework when offered through a CMS-approved, […]
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