Tag

mobileapp
Tired of Cancer, a digital health startup based in the Netherlands, announced their release of a mobile app for fighting cancer related fatigue (CRF).  The Untire App is the first of its kind and aims to improve the quality of life for cancer patients and survivors. Thirty to forty percent of cancer patients suffer from...
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Company: GE Healthcare, LLC Date of Enforcement Report: 6/26/2019 Class II PRODUCT LVivo EF app on Vscan Extend. Sold under the following product names: a. Vscan Extend Dual DICOM, Model Numbers H41212ZA, H41212RN; b .Vscan Extend Dual USB, Model Number H41212RK; c. Vscan Extend Dual Wi-Fi, Model Numbers H41212YZ, H41212RL; d. Vscan Extend Sector DICOM,...
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Company: Medtronic Inc. Date of Enforcement Report: 5/15/2019 Class II: PRODUCT Guardian Connect App CSS7200 used on the iPhone, iPad, and iPod Touch devices. Recall Number: Z-1282-2019 REASON The application may be closed by the operating system without alerting the user the app is no longer running or communicating with the transmitter resulting in the...
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Company: St Jude Medical Inc. Date of Enforcement Report: 5/1/2019 Class II: PRODUCT St. Jude Medical Confirm Rx Insertable Cardiac Monitor, REF DM3500, Sterile. Product Usage: The St. Jude Medical Confirm Rx insertable cardiac monitor (ICM) is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network (PCN). It is indicated...
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It’s nice to have medical device FDA regulations and guidance accessible without navigating through old websites or lugging printed copies around. Thankfully, SoftwareCPR’s free iOs and Android apps allow you to quickly view medical device regulations and guidance on your smartphone offline! As medical device consultants, we know from experience how important it is to...
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The Food and Drug Administration (FDA or the Agency) is announcing the establishment of a docket to solicit public comment on a proposed framework for regulating software applications disseminated by or on behalf of drug sponsors for use with one or more of their prescription drug products. Recognizing the opportunities for increased use of digital...
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The latest communication from FDA regarding regulation of medical apps notes that mobile medical apps can greatly help patients be proactive and vigilant about their own healthcare. There has been increased demand for medical apps, and many of the apps depend on high levels of feedback between patients and clinicians. The FDA wants to regulate...
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FDA provides examples of cleared Mobile Medical Apps.
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Dip.io was cleared for clinical urinalysis. The device includes test strips and a color coded card that is readable by smartphone to provide a result for several conditions including infection.
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You can search the app stores for SoftwareCPR® to download on an iPhone or Android. The app provides key FDA regulations and Software Guidances for quick reference and is organized by section. Impress your friends by accessing the exact text of FDA documents wherever you go. We plan to add additional documents over time.
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Want a free Android app as a quick reference to the regulations? Paul Felten of SoftwareCPR has developed a new app just for that purpose. You can find it by searching for “SoftwareCPR” in the Google Play store!  Google Play – SoftwareCPR app
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FDA issued a revision to its “Mobile Medical Applications” Guidance Feb 9, 2015. The revision was to make this guidance consistent with the final “Medical Image Storage Devices, and Medical Image Communications Devices” guidance. Specific changes are FDA’s exercising of enforcement discretion to exempt MDDS and some Mobile Medical Apps from compliance the FDA regualtion....
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The link provided is to FDA’s relatively new webpage related to connected health, including cybersecurity, Health IT, Mobile Medical Apps (MMA), and wireless medical devices. The MMA page provides lists of examples of types of MMApps and how they are or are not regulated. https://www.fda.gov/medicaldevices/digitalhealth/
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http://mobihealthnews.com/27563/in-tense-hearing-congressman-declares-software-is-not-a-medical-device/
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Brian Pate of SoftwareCPR now leads our specialized validation services for Mobile Medical Apps (MMApps), including our own simulator-based testing and automated unit and functional testing. For mobile apps that are regulated medical devices, we provide full design control and premarket submission support by compliance and validation experts with specific mobile app technical knowledge that...
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62304, FDA, and Emerging Standards for Medical Device and HealthIT
Instructors:  Brian Pate, John F. Murray, Jr
Location: Sunnyvale, CA, USA
Dates:  February 4-6, 2020
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Location: Boston, MA, USA
Dates:  June 2-4, 2020
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