Tag Archive | "mobile medical devices"

FDA To Require Electronic Reporting of Medical Device Errors


FDA To Require Electronic Reporting of Medical Device Errors   mobile medical devices mHealth MDRs FDA regulations FDA Last week, The U.S. Food and Drug Administration published a final rule in the Federal Register which requires that both device makers and importers document negative event reports for medical devices electronically.

“Upon the effective date of this final rule, manufacturers and importers are required to submit MDRs to the Agency in an electronic format that FDA can process, review, and archive,” the FDA announced.

The new rule formally takes effect August 14th, 2015.
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Research: More than 50M Wireless Health Monitoring Devices to Ship by 2017


Research: More than 50M Wireless Health Monitoring Devices to Ship by 2017   wireless monitoring wireless health monitoring wireless health telehealth mobile medical devices mobile healthcare mobile health mhealth research mhealth reports mhealth monitoring mHealth IMS research health monitoring consumer health New research out recently by IMS Research pegs the total number of wireless health devices shipped over the next five years at more than 50 million.  Interestingly, the firm suggests that consumers, not telehealth patients, will drive the most adoption of such devices.

According to the report, dubbed “Wireless Opportunities in Health and Wellness Monitoring – 2012 Edition,” medical devices bought by consumer to self-monitor their health will account for more than 80 percent of all wireless-enabled consumer medical devices in 2016.  The demand for self-monitoring one’s health, however, is growing much faster than that for telehealth implementation, according to the report.

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Remote Monitoring Provider Zephyr Integrates with Qualcomm’s 2Net mHealth Platform


Remote Monitoring Provider Zephyr Integrates with Qualcomms 2Net mHealth Platform   Zephyr remote patient monitoring remote monitoring Qualcomm Life Qualcomm 2Net Qualcomm mobile medical devices mHealth platform connectivity platform bioHarness 2Net platform 2Net Hub 2Net data system 2Net Zephyr Technology, a provider of various remote monitoring solutions, announced today that it now supports Qualcomm’s recently introduced 2Net Hub and mHealth platform — a cloud-based connectivity solution for healthcare information.

Zephyr’s technology is a perfect fit for Qualcomm’s new connectivity platform, as it’s developed a central mobile health portal that receives aggregated bio-data from the company’s bluetooth-based “BioHarness” mobile medical device.  The device collects vital sign information and communicates by using Android Smartphones to send the data back to the Mobile Health Portal.

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American Telemedicine Association, mHealth Initiative Weigh in on FDA’s Mobile Medical App Guidelines


American Telemedicine Association, mHealth Initiative Weigh in on FDAs Mobile Medical App Guidelines   the MRC the ATA MRC mobile medical hardware mobile medical devices mobile medical app regulation mobile medical app guidance mHealth Regulatory Coalition mHealth Initiative medical hardware Food and Drug Administration FDA mobile app guidance FDA ATA American Telemedine American Telemedicine Association Two more healthcare organizations are weighing in on guidelines proposed by the FDA to regulate mobile medical apps, joining other groups such as the mHealth Regulatory Coalition and HIMSS to offer comments and concerns on the future of mHealth regulation.

The American Telemedicine Association (ATA) and the mHealth Initiative have both come out with questions it’s asking the FDA to answer, following a public comment period on the 30-page draft document that ended on October 19th.

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Sensei Partners with IDEAL LIFE for Wireless Device Monitoring & Feedback Solutions


Sensei Partners with IDEAL LIFE for Wireless Device Monitoring & Feedback Solutions   wireless health monitoring wireless device monitoring Sensei mobile medical devices mobile healthcare apps mobile health applications mhealth devices mHealth apps mHealth applications medical monitoring medical devices IDEAL LIFE feedback monitoring biometric devices It was announced today that Sensei, Inc. — a provider of wireless health and wellness solutions — has partnered with IDEAL LIFE — maker of mobile medical devices and other wireless health solutions — to offer wireless device monitoring and feedback through Sensei’s cloud-based mHealth platform, Sensei Connect, in addition to a suite of mobile health applications.

Integrated mHealth solutions stemming from the new partnership include things like integrated biometric devices such as blood glucose meters, blood pressure meters, scales, and pedometers, with all data being wirelessly and securely transmitted to IDEAL LIFE and pushed to Sensei’s secure platform.  From there it’s transmitted to the individual’s mobile phone, allowing real time tracking and feedback.  The result is seamless data tracking and provision of immediate feedback, education and guidance to “promote engagement, understanding and better health outcomes,” according to the companies.

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Report: Wireless Patient Monitors the Fastest Growing Mobile Medical Device Segment


Report: Wireless Patient Monitors the Fastest Growing Mobile Medical Device Segment   remote patient monitoring remote monitoring patient monitoring mobile monitoring devices mobile medical devices mobile medical device communication mobile healthcare mobile health Mobile Devices mHealth market research Kalorama Information healthcare report healthcare information In a new report published today from market research firm Kalorama Information, it was found that wireless patient monitoring devices are currently the fastest growing segment in the larger medical device industry in terms of revenue earned.

Revenues for these devices have more than doubled in the last four years, and are expected to double again over the next four years.  With a growth rate of 23% between 2008 and 2010, these devices saw greater growth than what Kalorama had estimated for minimally invasive surgical devices, specialty catheters and defibrillators — devices which have drawn attention in recent years.

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Report: Four out of Five Practicing Physicians Use Smartphones, Tablets & Mobile Apps


Report: Four out of Five Practicing Physicians Use Smartphones, Tablets & Mobile Apps   tablets tablet devices smartphones slates slate devices physicians mobile research mobile medical devices mobile healthcare mobile health Mobile Devices mobile data mHealth Medical research medical report Jackson & Coker healthcare research healthcare report healthcare digital devices According to a new report out from Jackson & Coker, some 80% of practicing physicians use smartphones, tablets, mobile apps and “various other mobile devices” in their medical practices.

The new report, entitled Apps, Doctors, and Digital Devices, used research from several supplemental studies that analyzed the use of smartphones, mobile computing devices such as Apple’s iPhone and iPad, and a wide variety of software apps by physicians in different specialties.  As with most digital and mobile technologies that enter the healthcare space, security is the number one concern and one of the largest barriers for most physicians.

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