Integra LifeSciences (NSDQ:IART) issued an urgent field safety notice to warn of an issue with the 7 mm NeuraGen Nerve Guide due to one specific lot of parts that failed to meet release criteria. The NeuraGen Nerve Guide, part number PNG720, had one lot released that was out of specification for a finished goods release test. […]
Integra shares up on raised guidance, Street-beating earnings
Integra LifeSciences (NSDQ:IART) shares ticked up today on fourth-quarter results that revealed mixed results when compared to the consensus forecast but resulted in raised guidance for fiscal 2020. The Plainsboro, N.J.-based surgical devices company posted profits of $15.3 million, or 18¢ per share, on sales of $395.1 million for the three months ended Dec. 31, 2019, […]
Integra LifeSciences ticks up on Q3 beats
Integra LifeSciences (NSDQ:IART) shares ticked up in pre-market trading today after the medical device company reported third-quarter numbers that topped estimates. Plainsboro, N.J.-based Integra posted losses of -27.6 million, or -32¢ per share, on sales of $379.1 million for the three months ended Sept. 30, marking a swing to red ink on sales growth of […]
Integra Lifesciences touts Cadence ankle study
Integra LifeSciences (NSDQ:IART) yesterday touted positive findings from its Cadence total ankle system retrospective study and closed enrollment ahead of schedule for two post-market studies of the device. The study reported that patients treated with Cadence while suffering from end-stage arthritis experienced improvements in quality of life, functional measures and pain. The results were presented during […]
Integra LifeSciences buys Rebound Therapeutics
Integra LifeSciences (NSDQ:IART) said today that it has acquired Rebound Therapeutics, maker of a single-use, minimally invasive neurosurgery device. Financial terms of the deal were not disclosed. Rebound touts its Aurora Surgiscope system, — cleared by FDA in January — as the first single-use disposable neurosurgical endoscope. The Aurora system enables minimally invasive access, visualization and […]
Integra Lifesciences picks up Arkis Biosciences
Integra LifeSciences (NSDQ:IART) this week acquired Arkis BioSciences and its line of neurosurgery devices for an undisclosed amount. Knoxville, Tenn.-based Arkis makes the CerebroFlo external ventricular drainage catheter that uses its Endexo anti-thrombus additive to prevent blood clots. “Neurocritical care is an important area of focus for Integra. We recently introduced our CereLink intracranial pressure monitor […]
Integra LifeSciences tops Q2 consensus, raises earnings outlook
Integra LifeSciences (NSDQ:IART) today reported second-quarter results that beat the consensus estimate for both sales and earnings and raised its earnings outlook for the rest of the year. The Plainsboro, N.J.-based medical device company said profits rose 161.4% to $29.7 million, or 34¢ per share, on sales growth of 4.8% to $383.6 million compared with […]
Integra Lifesciences ticks up on Q1 earnings beat
Integra LifeSciences (NSDQ:IART) shares ticked up today in pre-market activity after the medical device company reported first-quarter earnings that beat the consensus forecast. Plainsboro, N.J.-based Integra posted profits of $32.8 million, or 38¢ per share, on sales of $359.7 million for the three months ended March 31, for bottom-line growth of 198.0% on flat sales […]
FDA warns Integra’s TEI Biosciences over quality, validation issues
The FDA recently revealed a warning letter it sent to Integra LifeSciences‘ (NSDQ:IART) TEI Biosciences over four noted violations it found during an inspection of TEI’s Boston-based facilities. The federal watchdog said that it inspected the company’s facilities where it produces collagen-based medical devices, including its Xenform soft tissue repair matrix, from last October to […]
Integra LifeSciences reveals FDA warning letter over chronic wound treatment
Integra LifeSciences (NSDQ:IART) today revealed its receipt of a warning letter sent by the FDA last week about quality system issues at a Boston-area plant that makes products to treat chronic wounds. Plainsboro, N.J.-based Integra said the FDA inspected the plant last October and November, resulting in a Form 483 covering the problems found there. […]
JenaValve names Kilcoyne as CEO | Personnel Moves – January 15, 2019
JenaValve Technology said today that it named former ReVision Optics prez & CEO John Kilcoyne as its new chief executive officer, effective immediately, replacing Dr. Victoria Carr-Brendell, who has taken up an executive leadership position with Sonova Holding AG (SIX:SOON). Prior to his time at ReVision Optics, Kilcoyne served as prez & CEO at Micrus Endovascular where he […]
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