Tag Archive | "FDA"

FDA Green Lights Marketing of Sentrian Remote Patient Intelligence Solution

FDA Green Lights Marketing of Sentrian Remote Patient Intelligence SolutionFDA clearance — it’s not easy to get, but when you manage to get it, it’s a major accomplishment and a critical component in modern healthcare tech marketing.

Sentrian, a Remote Patient Intelligence company, says it has received confirmation from the Food & Drug Administration that its Remote Patient Intelligence solution reportedly meets the definition of a “medical device” for which the FDA intends to exercise “Enforcement Discretion.”

The designation identifies medical devices that “are not subject to further FDA regulatory requirements at this time” and clears the way for Sentrian to immediately begin marketing its RPI solution broadly in the U.S.
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Medtronic Gets FDA Green Light for MiniMed Connect

Medtronic Gets FDA Gteen Light for MiniMed ConnectA representative from medical technology company Medtronic tells mHealthWatch that the organization has secured U.S. Food and Drug Administration (FDA) clearance for MiniMed Connect.

MiniMed Connect is designed to provide a mobile connection to critical information for managing diabetes.

We’re told that the resource in question is the first product to enable people with diabetes to discreetly and conveniently view their insulin pump and continuous glucose monitor (CGM) data on a smartphone and provides remote monitoring and text message notifications for their loved ones.

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The Need For Well-Designed And Tested Insulin Apps Is Still Alive And Well

The Need For Well-Designed And Tested Insulin Apps Is Still Alive And WellWhile you can head online and find close to 50 paid apps designed to determine proper dosing for insulin, a recent study by Global eHealth Unit at the Imperial College London has found that the vast majority of these apps fall short. In fact, many of these apps were developed during the app boom, and have not been updated in years.

While an app that can accurately calculate mealtime dosing for short-acting insulin after entering in carbohydrates, pre-meal blood sugar, physical activity, and other pertinent information seems as though it would be both easy and convenient, most apps struggle with even these basics. The study, highlighted by MedPage Today, found that:

  • 30% of the apps would not share their formula
  • 91% had incorrect techniques for numeric inputs
  • 67% showed risk factors for inappropriate dose recommendations because their actual calculation did not match their formula
  • 24% did not operate consistently

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FDA Plans to Take a Hands Off Approach to Apple Watch

FDA Plans to Take a Hands Off Approach to Apple WatchWith Apple Watch set to launch on April 24th, questions have swirled around how the FDA might intervene to somehow regulate the first-ever wearable released by Apple.

But this week, the FDA is making their position on the matter very clear. They want very little, if anything, to do with putting up regulatory hurdles for Apple Watch.

“We are taking a very light touch, an almost hands-off approach,” Bakul Patel, the FDA’s associate director for digital health, is quoted by Bloomberg. “If you have technology that’s going to motivate a person to stay healthy, that’s not something we want to be engaged in.”

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FCC and FDA Team Up for Joint Workshop

workshopIn a joint statement released to the media this week, the FCC and FDA have announced their agenda for a joint workshop on medical technology innovation and wireless test beds.

We’re told that Chairman Tom Wheeler and Commissioner Mignon Clyburn of the FCC, and Dr. William Maisel, Deputy Director, Center for Devices and Radiological Health, FDA, will address workshop participants.

The workshop is set for next Tuesday, March 31st.
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FDA Launches ‘Drug Shortages’ Mobile App

FDA Launches 'Drug Shortages' Mobile AppThe U.S. Food and Drug Administration has just launched what’s being called the agency’s first mobile application “specifically designed to speed public access to valuable information about drug shortages.”

Conveniently, the app identifies current drug shortages, resolved shortages and discontinuations of drug products.

Drugs in short supply can delay or deny needed care for patients. Drug shortages may also lead health care professionals to rely on alternative drug products, which may be less effective or associated with higher risks than the drug in shortage.

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FDA Green Lights Promising New Continuous Glucose Monitoring System

FDA Green Lights Promising New Continuous Glucose Monitoring SystemOn Monday, DexCom, Inc. — a provider of glucose monitoring solutions for patients with diabetes — announced that it has received U.S. Food and Drug Administration’s approval for its Dexcom G4 PLATINUM Continuous Glucose Monitoring System with Share.

According to a statement provided to mHealthWatch, the Dexcom Share receiver uses a secure wireless connection via Bluetooth Low Energy (BLE) between a patient’s receiver and an app on the patient’s smartphone to transmit glucose information to apps on the mobile devices of up to five designated recipients.

This can happen, the company says, without the need for a dedicated docking cradle.
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