Articles By Jof Enriquez

81. Aspect Biosystems One Of 15 New Partnerships For J&J 1/9/2017

    Johnson & Johnson's (J&J) DePuy Synthes unit, through J&J Innovation, is partnering with Canadian biotech company Aspect Biosystems to research and make a prototype artificial meniscus using Aspect's proprietary Lab-on-a-Printer 3D-printing technology.

82. Abbott Completes $25 Billion Purchase Of St. Jude Medical 1/6/2017

    The deal makes St. Jude a wholly-owned subsidiary of Abbott, which is now considered a major player in the $30 billion cardiovascular space, competing with market stalwarts like Medtronic and Boston Scientific.

83. House Bill To Permanently Repeal Device Tax Filed Anew 1/5/2017

    U.S. Reps. Erik Paulsen (R-Minn.) and Ron Kind (D-Wisc.) have reintroduced a bill in the U.S. House of Representatives seeking to permanently repeal the medical device excise tax, which currently is suspended until Dec. 31, 2017.

84. FDA Finalizes Guidance On Benefit-Risk Factors Influencing Device Availability, Compliance, Enforcement Decisions 1/4/2017

    The U.S. Food and Drug Administration (FDA) has finalized its guidance on benefit-risk factors to consider when making medical device product availability, compliance, and enforcement decisions across the total product life cycle. The document provides a general framework for FDA and stakeholders that sets forth overarching benefit-risk principles.

85. FDA Finalizes Cybersecurity Guidance On Postmarket Devices 1/3/2017

    The U.S. Food and Drug Administration (FDA) has released a final guidance covering management of postmarket cybersecurity vulnerabilities for marketed and distributed medical devices.

86. FDA Issues List Of Priority Device Guidances For 2017 12/29/2016

    The U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) has posted the lists of medical device guidance documents it will prioritize for fiscal year 2017, pursuant to the Medical Device User Fee Amendments of 2012 (MDUFA III) (Public Law 112-114).

87. FDA Expands Indication For Dexcom's G5 CGM For Insulin Dosing 12/27/2016

    The U.S. Food and Drug Administration (FDA) is permitting the use of Dexcom's G5 Mobile Continuous Glucose Monitoring (CGM) System for insulin dosing without additional finger pricking, making the G5 the first device of its kind to be granted such an approval.

88. Stryker Embarks On $130 Million R&D Expansion In Michigan 12/22/2016

    Stryker is building a $130-million corporate campus in Portage, Mich., near Kalamazoo, where the medical device manufacturer is headquartered. The expansion creates 105 new area jobs for engineers and scientists over the next three years, officials said.

89. FDA Makes Final Rule On Postmarketing Safety Reporting For Combination Products 12/21/2016

    The U.S. Food and Drug Administration (FDA) has issued the final rule describing the postmarketing safety reporting requirements for combination products, which comprise any two or three constituent parts — namely, a medical device and/or a drug and/or a biologic.

90. UK's NICE Joins FDA Program To Speed Payer Coverage, Access To Medical Devices 12/19/2016

    The United Kingdom's National Institute for Health and Care Excellence (NICE) says it is working with the United States Food and Drug Administration’s (FDA) Payer Communication Task Force (PCTF) in assisting sponsors of medical devices and diagnostics gather and demonstrate the clinical efficacy and cost-effectiveness of their products.