Articles By Jof Enriquez

  1. Abbott CEO Confident In Closing Alere Deal, Solving St. Jude Facility Issue

    Abbott CEO Miles White is optimistic that the company will overcome remaining hurdles to complete the purchase of Alere by the end of the third quarter, and that it will clear up manufacturing quality issues involving a plant acquired from St. Jude Medical.

  2. J&J "Making Good Progress" With Restructuring, Mulling "Various Options" For Diabetes Business

    Johnson & Johnson (J&J) says it is making good progress with ongoing restructuring of its medical device business, but the company still is considering various options for its diabetes unit, including potential partnerships or divestitures.

  3. Abbott, Alere Move Ahead With Merger, Withdraw Lawsuits

    Abbott Laboratories has agreed to proceed with its purchase of diagnostics firm Alere — for $500 million less than its original price offer.

  4. BioTelemetry Offers To Acquire LifeWatch For $257 Million

    BioTelemetry, Inc. is extending a tender offer to acquire all outstanding shares of rival cardiac monitoring company LifeWatch AG for an estimated total transaction value of 260 million Swiss francs (U.S. $257 million).

  5. FDA Clears Ventec's Five-In-One Portable Respiratory Device

    The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to Ventec Life Systems' VOCSN, a portable respiratory system that combines five separate medical devices — a ventilator, oxygen concentrator, cough assist system, suction, and nebulizer.

  6. IMDRF Guideline Seeks To Unify Adverse Event Terminology, Coding

    The International Medical Device Regulators Forum (IMDRF), a voluntary group of international medical device regulators, has released a final document containing harmonized terminology for reporting adverse events, with matching alpha-numeric codes and examples for medical devices and in vitro diagnostics (IVDs) in both premarket and postmarket settings.

  7. FDA Explains Alternative Means To Generate Evidence For Device Studies

    Food and Drug Administration (FDA) officials wrote in a recent issue of The New England Journal of Medicine (NEJM) that flexible and alternative means to generate clinical evidence, such as existing registries and computer modeling techniques, could form the basis for approving more medical devices in the future.

  8. Medtronic, WUSM, NIH Collaborate To Better Map And Excise Brain Tumors

    Medtronic and researchers at Washington University School of Medicine in St. Louis are using $3.6 million in funding from the National Cancer Institute of the National Institutes of Health (NIH) to build advanced surgical planning software based on customized 3D magnetic resonance imaging (MRI) brain scans.

  9. European Parliament Adopts New Rules To Tighten IVD, Medical Device Regulation

    The European Parliament has voted to enact final legislation for long-awaited Medical Device Regulations (MDR) and In Vitro Diagnostics Regulations (IVDR) that will tighten how these products are marketed in Europe. These regulations will fully apply after a transition period of three years for medical devices, and five years for in vitro diagnostic devices.

  10. BD Completes $250M Buy Of Infusion Systems Maker Caesarea Medical

    Becton Dickinson (BD) is buying the remaining 60 percent stake of Caesarea Medical Electronics (CME) to fully acquire the Israel-based manufacturer of infusion products, in a deal estimated to be worth $250 million.