Tag Archive | "U.S. Food and Drug Administration"

HealthInterlink Clears Integral FDA Hurdle


HealthInterlink Clears Integral FDA Hurdle   U.S. Food and Drug Administration mobile health mHealth HealthInterlink FDA On Wednesday, HealthInterlink – a medical software company specializing in remote patient monitoring – finally received the good news for which it had been waiting for quite some time.

According to a statement provided to mHealthWatch, the company has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market Beacon version 2.0.

The platform in question is billed as a “flexible, affordable, and scalable” software-based remote patient monitoring solution.

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FDA Issues Draft Guidance on Mobile Blood Glucose Meters


FDA Issues Draft Guidance on Mobile Blood Glucose Meters   U.S. Food and Drug Administration Mobile Devices Mobile Blood Glucose Meters mHealth news mHealth FDA This week, the U.S. Food and Drug Administration published draft guidance on the matter of blood glucose meters – meters that are increasingly going mobile.

The guidance strives to separate prescription meters for use in point-of-care healthcare environments and over-the-counter meters for consumers.

The draft guidance is available now through the Federal Register for public comment.
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Alere’s MobileLink Secures FDA Clearance


Aleres MobileLink Secures FDA Clearance   U.S. Food and Drug Administration FDA clearance Aleres MobileLink MHW can confirm that Alere Connect has been granted a 510(k) market clearance by the U.S. Food and Drug Administration for the Alere MobileLink.

The new product offering is one of Alere’s connected device technologies designed to assist patients by allowing self-testing at home and delivering data quickly to clinical systems accessed by their healthcare providers.

Alere MobileLink provides a gateway to Alere’s Connected Health platform, which offers integrated tools and services that can enhance care and improve outcomes for all patients, whether they are participants in health and wellness or chronic disease management programs.

“Our remote monitoring solutions have been validated over the years with innovative healthcare organizations throughout the US,” says Alere Connect CEO Kent Dicks.
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Verizon Secures FDA Clearance For Remote Health Monitoring Solution


Verizon Secures FDA Clearance For Remote Health Monitoring Solution   verizon U.S. Food and Drug Administration telemedicine mobile health Converged Health Management Verizon has received U.S. Food and Drug Administration 510(k) clearance for Converged Health Management.

The solution in question is a cloud-based, remote patient-monitoring medical device.

According to details shared by Verizon, this marks the first time Verizon has sought and gained FDA clearance for a healthcare solution.

Verizon’s new solution, which resides in the company’s HIPAA-ready cloud, provides clinicians with access to up-to-date patient data from connected biometric devices so they can more efficiently monitor and manage patients from their home, or when they are on the go.

Health management remains an untapped area with the potential for enabling clinicians to help patients help themselves through improved awareness of their condition.  In addition, access to up-to-date patient health data enables clinicians to deliver more personalized care to patients.

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Online Pharmacies Closed Following International Raids


Online Pharmacies Closed Following International Raids   U.S. Food and Drug Administration online pharmacies The U.S. Food and Drug Administration and Interpol seized and shut down over 1,600 online pharmacies in late June, according to an FDA press release. All of the now-defunct online pharmacies were found to be selling counterfeit or unapproved medication.

The action occurred as part of the 6th annual International Internet Week of Action (IIWA), which the FDA press release describes as a “global cooperative effort to combat the online sale and distribution of potentially counterfeit and illegal medical products.”

In addition to over 1,600 websites being shut down, the FDA took action against over 9,600 websites, including the issuance of regulatory warnings and the seizure of over $41 million worth of offending medications.

The FDA found that over 97 percent of the websites involved in the analysis did not fully comply with state and federal regulations. In addition, 88 percent did not require customers to have a prescription, and over half of the websites sold drugs that were not approved by the FDA.

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FDA Green Lights myVisionTrack for iPhone-Based Vision Testing


FDA Green Lights myVisionTrack for iPhone Based Vision Testing   Vital Art and Science Inc U.S. Food and Drug Administration myVisionTrack mHealth iPhone Based Vision Testing FDA Illustrating once again the inextricable link between Apple’s iPhone and myriad aspects of the healthcare industry, Vital Art and Science Inc. has received U.S. Food and Drug Administration clearance to market myVisionTrack.

myVisionTrack is a prescription-only medical device that enables patients with retinal diseases to monitor their vision function between regular visits to their eye-care professional to help ensure they obtain timely care and treatments.

myVisionTrack has been hailed as a revolutionary step in the right direction for mHealth, particularly given the unfortunate reality that age-related macular degeneration (AMD), diabetic retinopathy (DR) and other retinal diseases afflict more than 40 million people in countries with advanced health care systems.

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Federal Hearings on mHealth Regulations Begin Next Week


Federal Hearings on mHealth Regulations Begin Next Week   U.S. Food and Drug Administration technology House Energy and Commerce hearings healthcare FDA With debate reaching fever pitch over the U.S. Food and Drug Administration’s supposed consideration of regulations that could impact smartphones, tablets and mHealth apps, all eyes turn to Washington ahead of next week’s hearings on the Hill.

Lawmakers from the House Energy and Commerce committee will probe possible ways that regulation would impede further growth and innovation of mobile technologies in the field of healthcare.

The hearings follow a letter the committee sent to the FDA earlier this month, in which lawmakers questioned whether the Patient Protection and Affordable Care Act could allow the FDA to define smartphones and tablets with health-related apps as “medical devices” — and levy new taxes on developers and smartphone makers under the health-care law.

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