Treatment of Peripheral Artery Disease Headlines the News This Week
November 7, 2014
By Andrew Hoglund

There were a number of stories this week in the news that revolved around the treatment of peripheral artery disease. Peripheral artery disease (PAD) is when the arteries narrow and there is restricted blood flow to the limbs. Often times it is caused by the buildup of plaque in the artery walls. Medtronic and Shockwave Medical had promising studies released this week showing that their drug-coated balloons could help treat PAD while Covidien was cleared by the FDA for its directional atherectomy system. Medtronic’s device, the IN.PACT Admiral drug-coated balloon,

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Dexcom, Illumina, and Siemens in the news this week
October 24, 2014
By Andrew Hoglund

FDA approves Dexcom smartphone-enabled device, Dexcom Share, for continuous glucose monitoring Dexcom was cleared by the FDA for the Dexcom Share, an add-on to its Dexcom G4 Platinum continuous glucose monitoring device that wirelessly transmits patients’ glucose levels through a smartphone using Bluetooth technology. Patients can then upload the information through the app and choose up to 5 recipients to receive the data. The recipients can then track the information through either an Apple computer or an Apple mobile device.   Illumina is up 10% on strongest its growth since

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Navigating your Medical Device Through FDA
September 30, 2014
By Allison Komiyama

So you have a medical device and want to start selling it to help human kind… oh, and maybe turn a profit! But before you can legally market in the US, you’ll likely need to navigate the FDA submission process. FDA determines the classification of medical devices in the US based on the level or risk they pose to patient or end user. Class I devices are thought to have the lowest level of risk and are often exempt from any premarket submission. Logically, regulatory control increases from Class I

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