LiFEDATA

LiFEDATA Systems is a technology company based in the Philippines that offers health-related software products, including an electronic medical record (EMR) solution. Products include EMR management for the clinician, patient access to their own records, and a solution for HMO administrators, among other offerings.

According to the corporate website, LiFEDATA MD, the company's EMR system, was named "Groundbreaking Technology of the Year" in both 2008 and 2009 by the Philippine Department of Trade and Industry and Center for International Trade Expositions and Missions.

The authors of...

November 23rd, 2016
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Tonic

In June 2016, Telenor Group, described on its corporate website as a large mobile operator with more than 185 million customers throughout Asia, launched a digital health service called Tonic through its health subsidary, Telenor Health.

Tonic is being introduced first in Bangladesh through Grameenphone, a Telenor mobile operator. According to a press release, Tonic's services are available to Grameenphone's 57...

November 23rd, 2016
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Swasthya Slate

 

The Swasthya Slate is a device that combines various sensors and monitors to enable numerous diagnostics tests to be run on one small, mobile, affordable, easy-to-learn system that is connected to an app.

According to the Swasthya Slate website, there are 33 tests available, ranging from the basic—blood pressure, urine tests, pulse oximetry, stethoscope, heart rate, and body temperature—to the more complex, such as HIV-1 and HIV-2, syphilis, malaria, dengue, HCV, and rheumatoid factors. Pregnancy tests and fetal doppler are available too. Test...

November 23rd, 2016
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Telescrypts

Telescrypts combines a wearable device with a smartphone app to bring healthcare services to hard-to-access areas of developing countries. The wearable device, used to collect data, is designed for durability. Data is stored in the cloud and can be accessed and analyzed by clinicans

The company has locations in Phoenix, AZ, Addis Ababa, Ethiopia, and Arusha, Tanzania.

Founder and CEO Omron Blauo, who was one of Medtech's Rising Stars this year, told MD+DI that the company's main goal is "...

November 23rd, 2016
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Earlier-than-expected FDA approval of a new medical device seems like it should be a win on all counts. But as Medtronic's latest earnings report shows, an early approval can slow sales—at least temporarily.

Marie Thibault

Medtronic's MiniMed 670G insulin pump system received FDA approval ahead of schedule.

Medtronic has set a fast pace for regulatory approvals in its diabetes business.

In August, the company announced the U.S. launch of its MiniMed 630G insulin pump system. Then, just a few weeks later, in late September, FDA approved Medtronic's next-generation MiniMed 670G insulin pump system....

November 22nd, 2016
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FDA's final guidance on Medical Device Reporting for Manufacturers eliminates the need to report use errors that don't result in death or serious injury. An expert explains why this change is a problem.

William A. Hyman

The FDA has released a final guidance on Medical Device Reporting for Manufacturers. This follows the corresponding draft guidance of July 2013 and replaces the guidance of March 1977, which is no longer available on FDA’s website. That guidance was ambiguous with regard to the reporting of non-injurious malfunctions caused by user error. Among various revisions from the 2013 draft is the treatment of user error, which the guidance also calls “use error.”

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November 21st, 2016
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A new process for creating instructions for use for medical devices cuts down on the time-consuming and costly steps of the cycle by asking end users for more input.

Annie Diorio-Blum

The common approach to designing and developing an Instructions For Use (IFU) has been largely unchanged for years: once a product is designed and made ready for manufacturing, an IFU is then written and tested. When errors are found, changes are made, and the cycle repeats until there is an acceptable IFU version that most users will be able to comprehend. Clearly, this approach is often time consuming and costly.

Even with the more recent fundamental shift in how medical devices and products are designed—with most manufacturers moving towards a “user...

November 18th, 2016
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Patent protections for Software as a Medical Device are increasingly important due to the additional investments in clinical evaluation that may be needed to withstand the FDA scrutiny under the new draft guidelines. 

Baldassare Vinti

 

In August, FDA released draft guidance entitled “Software as a Medical Device (SaMD): Clinical Evaluation,” which was prepared by the International Medical Device Regulators Forum (IMDRF) in an attempt to provide globally harmonized principles concerning clinical evaluation for medical device software. The draft guidance, when finalized, will represent the...

November 18th, 2016
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Here are ten strategies that medical device makers of all sizes can use to build a solid patent portfolio.

Hyeongsu Rick Park and Ron Schoenbaum

Medical device companies, especially those in startup mode, frequently struggle to build a patent portfolio. A patent portfolio can help a company protect its market share by asserting its patent rights against infringers and can generate revenue through license or sale. For startup companies, a patent portfolio is often important for obtaining funding. However, companies sometimes fail to obtain patent rights. In many cases, the failure to obtain patent protection results from an absence of established procedures for identifying and assessing potentially patentable inventions. In other cases, the failure is attributable to contractual...

November 17th, 2016
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Medtronic

On November 9, the day after the election, Omar Ishrak, Medtronic's chairman and CEO, sent the following tweet from his Twitter account, @MedtronicCEO:

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November 16th, 2016
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