Current Headlines

  1. FDA Clarifies Medical Device UDI Marking Process

    The U.S. Food and Drug Administration (FDA) has released new draft guidance pertaining to the direct marking of unique device identifiers (UDI) on medical devices. The document contains compliance dates, exemptions, methods of direct marking, and interpretation of "reprocessing" for direct marking requirements. It is the latest in a series of guidance documents related to the FDA's UDI program, which tracks devices in order to assess adverse event reports more effectively.

  2. Blackberry To Design Bacteria-Free Smartphone

    Blackberry plans to give healthcare workers one less thing to worry about in the fight against hospital-acquired infections (HAIs) by designing a bacteria-free smartphone. In recent years, Blackberry has lost its foothold in the broader smartphone market, but many believe this move could re-establish the company in the healthcare sector.

  3. Human Organ-Mimicking Chip Could Revolutionize Clinical Trials

    The Organs-on-Chips technology, created at Harvard University’s Wyss Institute, is a piece of clear flexible polymer, roughly the size of a flash drive, that contains hollow microfluidic channels lined with human stem cells coaxed into mimicking a particular organ. So far, the research team has designed chips to mimic fifteen organs including the heart, lungs, liver, eyes, and intestines.

  4. Zimmer Closes Biomet Deal, Sells Knee Implant Biz To Smith & Nephew

    Zimmer's acquisition of Biomet will result in a transaction worth about $14 billion and the new company will be known as Zimmer Biomet Holdings, Inc. The new entity’s headquarters will be in Warsaw, Ind., where both Zimmer and Biomet already were based. The merger is contingent upon Zimmer’s sale of the rights and assets to its U.S. ZUK unicondylar knee implant to London-based Smith & Nephew, as well as Biomet's sale of the rights and assets to its U.S. Discovery Total Elbow implant and Cobalt Bone Cement to Vista, Calif.-based DJO Global, Inc.

  5. Google Developing Wristband For Clinical Applications

    Google has unveiled a new wristband that would provide doctors with "minute-by-minute" clinical information from wearers of the device. Unlike similar wearables from rivals targeting the consumer market, Google's device is being designed to extend clinical and drug studies beyond trial sites. The experimental wristband can measure a wearer's vital signs, such as pulse, heart rhythm, and skin temperature, as well as monitor ambient information, like light exposure and noise levels. 

  6. FDA Clears Medtronic’s Recapturable, Repositionable TAVR

    Medtronic has announced that its Evolut R transcatheter aortic valve replacement (TAVR) system has been cleared by the U.S. Food and Drug Administration (FDA). This is the second big U.S. win for Medtronic TAVR systems — CoreValve was approved last year — and this newest innovation is the first recapturable and repositionable TAVR system offered in the U.S. TAVR technology was developed as a non-invasive valve replacement alternative for high-risk patients deemed too sick to undergo open heart surgery. 

  7. Sorin And Cyberonics Unveil Name Of Combined Company: LivaNova™

    Sorin S.p.A., (MTA; Reuters Code: SORN.MI "Sorin"), a global medical device company and a leader in the treatment of cardiovascular diseases, and Cyberonics, Inc. (NASDAQ: CYBX, "Cyberonics"), a medical device company with core expertise in neuromodulation, today unveiled LivaNova as the name of their combined company, effective at the close of their proposed merger.

  8. Proto Labs Brings Seamless Quoting To Autodesk Fusion 360

    Leading custom prototyping and low-volume parts manufacturer, Proto Labs, Inc., has teamed up with Autodesk to provide easy access to Proto Labs’ online quoting system directly within Autodesk’s Fusion 360.

  9. Premier Showcases Medical Innovations Designed To Improve Patient Care

    Premier, Inc. selected a range of unique medical devices and products for its 7th annual Innovation Celebration, an event honoring the industry’s leading healthcare advancements and supplier commitment to innovation. Showcased during Premier’s annual Breakthroughs Conference and Exhibition, the innovative products and devices were selected based on their uniqueness, ability to have an impact on unmet clinical needs and potential to improve patient care.

  10. Laser Frequency Combs Advance Medical, Measurement Tech

    Laser frequency combs are "rulers" of light that, very simply, measure different light frequencies that are evenly spaced. The exact spacing of frequencies is key to manipulating light for various applications. One application has dramatically improved optical atomic clocks. Another is a medical breath analyzer. Laser frequency combs also are used as precision rulers to search for exoplanets outside our solar system. In the lab, experimental physicists use them to watch chemical reactions unfold in real time.

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