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Home » Newsletters » BioWorld MedTech

BioWorld MedTech

March 29, 2018

View Archived Issues

Dexcom receives FDA de novo nod for G6 CGM

Dexcom Inc. won an FDA de novo request for its Dexcom G6 continuous glucose monitoring (CGM) system, an upgrade from its prior G5 system, and one that eliminates the need for fingersticks. The device was approved for patients with diabetes as young as two years old, and can be used as a standalone system or with an automated insulin dosing (AID) system. Approval also means that the FDA has created standards and controls for CGM accuracy, clinical relevance, reliability, and study data requirements for CGM devices. Read More

U.K. startup launches first fingerprint-based test to screen for illegal drug use

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China's CMDE releases draft guidance on registering 3-D printed medical devices

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Accounting mandates in flux due to tax reform, new revenue standards

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GE building on HECAM partnership to introduce 3-D tools for treating liver cancer

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Appointments and advancements

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Financings

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Regulatory front

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Product briefs

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Other news to note

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BioWorld MedTech's Orthopedics Extra

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