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December 12, 2012
14:59 EDTBABYNatus Medical says FDA re-classified recall as Class I, expected cost immaterial
Natus Medical Incorporated released a statement regarding the issuance by the FDA of a recall notice for the company's Olympic Cool-Cap. The recall addresses a situation where the Cool-Cap screen freezes and interrupts patient cooling. Natus had previously communicated the problem to customers in May by issuing a Class II recall notice, which is the FDA's mid-level health hazard classification. Customers are able to recover from the screen freeze failure by simply rebooting the Cool-Cap system. Cooling treatment can continue in a safe manner with the Cool-Cap system as originally intended. The company has provided recall information to the FDA as required in a timely manner since this problem originated. Today's announcement indicates that the FDA has re-classified this action as a Class I recall which is the highest relative degree of health hazard classification for a product recall. As a result of this reclassification, Natus will be sending follow up safety notice letters to all customers reminding them how to recognize this screen freeze condition and how to recover from it. Separately, an unreliable power supply module is being replaced on an ongoing basis in effected units. The costs of the measures described above are not expected to be material, including costs yet to be incurred, and were previously accrued as an expense in the company's financial results for the nine months ended September 30. The recall does not prevent the company from continuing to market and sell the Cool-Cap, nor does it prevent clinicians from using the device. Revenue from the Cool-Cap represents less than 1% of the company's consolidated revenue.
News For BABY From The Last 14 Days
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April 22, 2015
14:09 EDTBABYNatus Medical price target raised to $45 from $42 at Roth Capital
Roth Capital increased its price target on Natus after the company reported higher than expected Q1 EPS and raised its guidance. The firm is now more confident about the company's ability to achieve its long-term operating margin goal of 20% in 2016. It keeps a Buy rating on the shares.
06:17 EDTBABYNatus Medical raises FY15 non-GAAP EPS to $1.47-$1.51 from $1.42-$1.46
FY15 EPS consensus $1.45. Raises FY15 revenue to $376M-$378M from $373M-$375M, consensus $374.63M.
06:15 EDTBABYNatus Medical sees Q2 non-GAAP EPS 31c-33c, consensus 32c
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06:15 EDTBABYNatus Medical awarded $32.5M California Hearing Coordination Center contract
Natus Medical announced that it has been awarded a five-year, $32.5M contract to provide hearing screening coordination services for the state of California. Natus works with hospitals and caregivers in the hearing screening community to track and monitor hearing loss in infants and guides families to the appropriate services as soon as possible.
06:14 EDTBABYNatus Medical reports Q1 non-GAAP EPS 31c, consensus 29c
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