Category: Uncategorized

FDA to Host Public Meeting Concerning MDUFA

The FDA is hosting a public meeting titled “Medical Device User Fee Amendments” on Wednesday, November 2, from 9 a.m. to 5 p.m. EST at its Silver Spring, Md., location. The purpose of the meeting is to discuss proposed recommendations for the reauthorization of the Medical Device User Fee Amendments (MDUFA) for fiscal years 2018 through 2022.

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BD Unveils Point-of-Care Diagnostic Device

Becton, Dickinson and Co., aka BD, has launched a wireless rapid diagnostic system for the detection of influenza A and B, respiratory syncytial virus, and group A strep. The new wireless BD Veritor Plus System provides health care providers with objective, lab-quality immunoassay test results within minutes.

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FDA Clears Pediatric Vision Scanner

The US FDA has cleared REBIScan’s Pediatric Vision Scanner (PVS)—a handheld device that helps physicians screen for amblyopia (“lazy eye”) and strabismus (misaligned eyes) in young children. Such technology is a boon to the medical community, REBIScan officials say, since amblyopia and strabismus are easiest to treat in preschoolers.

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Nihon Kohden Announces American Expansion

Nihon Kohden, a Tokyo-based medical device manufacturer, is opening a technical support call center in Allentown, Pa. The company’s new 6,000-square-foot facility will complement the call center at its Irvine, Calif-based U.S. headquarters, allowing it to more quickly reach customers on the East Coast.

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Abbott Buys St Jude Medical, Creating Cardiovascular Device Powerhouse

Abbott and St Jude Medical have announced a deal for Abbott to acquire St Jude Medical, strengthening Abbott's position in the cardiovascular, diabetes, vision, and neuromodulation markets. The new company will occupy the first or second position across the cardiovascular device markets, with combined annual sales totaling approximately $8.7 billion.