Musculoskeletal Clinical Regulatory Advisers said Wednesday it aided VertiFlex in winning pre-market approval from the FDA for its Superion interspinous spacer. The neuro-musculoskeletal and orthopedic advising and research organization said its assistance to Vertiflex helped reduce the average 26-month PMA review period to only 14 months. The Superion approval, won in May, marks the 1st spinal […]
VertiFlex Inc.
VertiFlex wins FDA nod for Superion spine device
VertiFlex said today that it won pre-market approval from the FDA for its Superion interspinous spacer for treating moderate lumbar spinal stenosis.
FDA panel green lights VertiFlex spinal stenosis device
A FDA advisory panel has recommended the agency approve VertiFlex Inc.’s Superion interspinous spacer system for the treatment of spinal stenosis.
According to VertiFlex, the panel based their vote largely on results from the company's 470-patient clinical trial.
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FDA postpones panel meeting for VertiFlex’s Superion spine device
The FDA postponed a meeting of 1 of its advisory panels that’s slated to review the pre-market approval application for the Superion spine implant made by VertiFlex.
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VertiFlex lands FDA panel date for Superion interspinous spacer
VertiFlex Inc. won a date with an FDA advisory panel to review the data behind its Superion interspinous spacer ahead of its bid for pre-market approval from the watchdog agency.
VertiFlex lands Medicare coverage for its spinal stenosis device
VertiFlex won reimbursement coverage from the Centers for Medicare & Medicaid Services for the company’s Totalis direct decompression system for treatment of spinal stenosis.
Stryker buys VertiFlex spinal implant assets
Stryker‘s (NYSE:SYK) spine division acquired some non-core assets from medical device company VertiFlex for an undisclosed amount.
San Clemente, Calif.-based VertiFlex said the technology is "not core to the ongoing strategic operations of the company" and that it plans to us the cash for its line of lumbar spinal stenosis products.
VertiFlex lands FDA wins for its spine implants
San Clemente, Calif.-based Vertiflex announced FDA clearances for its Totalis Direct Decompression System and UniVise Spinous Process Fixation System.
The twin regulatory wins, received in Noveber and December respectively, expand the company’s product portfolio for the treatment of lumbar spinal diseases, the company said.
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