Baxter

Device: All unexpired lots of the 50 mm 0.2 Micron Filter with product code H93835

Recall reason: According to information on the FDA recall page, the agency received "reports about the presence of particulate matter and the potential absence of filter membrane layers int eh filter set . . . [this] may contaminate a solution. This could result in bloodstream infections that may cause fever, septic shock, multiple organ dysfunction, and other serious adverse health consequences including death."

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December 2nd, 2016
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2016 was a big year for medical device recalls, with the number of units recalled in the third quarter reaching the highest level in four years. Here are the 10 recalls that impacted the most medical device units in the United States.

Medical device recalls hit a high in the third quarter of 2016, according to a Q3 report from the Stericycle ExpertSolutions Recall Index. That report found that the number of device recalls in the quarter was the highest observed since 2000 and the number of recalled units was the highest seen since the third quarter of 2012.

We reviewed...

December 2nd, 2016
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Quanterix is focused on detecting small concentrations of protein biomarkers to enable earlier diagnosis of cancer.

Frank Vinluan

 

Quanterix's Simoa instrument, which can detect low concentrations of protein in a sample of blood, offers the potential for earlier diagnosis of disease. 

When cancer is suspected, a simple blood test can confirm it. Liquid biopsies detect the presence of tumor cells or cancer DNA circulating in the blood. But by that point, a cancer may already be advanced. Kevin Hrusovsky, CEO of diagnostics technology company Quanterix, says a different biomarker can lead to an earlier diagnosis—...

December 1st, 2016
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President-elect Trump has tapped his nominees for Secretary of Health and Human Services and Administrator of CMS. Here are early reactions from around the medtech industry.

Marie Thibault

As President-elect Trump assembles his Cabinet, he has named two healthcare reformers to key positions. Rep. Tom Price (R-GA) is the nominee for Secretary of Health and Human Services. Seema Verma, MPH is the pick for CMS administrator.

Here is how industry onlookers and stakeholders are reacting to the nominations.

First, an Intro 

As MD+DI's sister publication, Qmed, reported following the announcement, Price spent almost twenty...

November 30th, 2016
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An expert offers a few tips on creating a differentiated product, understanding users, and how to get customers to keep coming back.

Marie Thibault

Livongo Health offers a connected glucose meter. Patients with diabetes can access their data and receive coaching using a companion website and app.

Connected health has drawn interest from traditional medtech companies, tech companies, and startups alike. Still, the field is relatively young and best practices for developing and selling a winning product have yet to emerge.

MD+DI asked Patty Spiller, director of marketing at Livongo Health, to share lessons learned from her experience at the...

November 29th, 2016
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Edwards Lifesciences is buying Valtech Cardio Ltd., which has developed the Cardioband System for transcatheter mitral and tricuspid valve repair.

Marie Thibault

Valtech's Cardioband System is designed for minimally invasive repair of the mitral and tricuspid valves.

Edwards Lifesciences has signaled its commitment to the transcatheter mitral valve space by announcing its acquisition of Valtech Cardio Ltd. 

Edwards will pay $340 million with a mix of stock and cash for Valtech, according to the company press release. There is also the potential for as much as $350 million in additional payments if certain milestones are reached.

The Israeli company...

November 28th, 2016
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There are significant opportunities for med tech companies to improve their working capital and inventory management practices by outsourcing non-critical areas of procurement. 

Eamon Butler

Procurement in the Medtech Industry

Medtech companies have traditionally been reluctant to outsource procurement activities for several important reasons:

  1. Supplier Quality Management—The strict quality control standards and regulations governing medical materials and components have obligated medtech companies to not only ensure the quality of their own processes, but also that of their supply network investments.
  2. Continuity of Supply—The importance of ensuring on...
November 28th, 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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The term "digital health" usually brings to mind high tech wearables or software from Silicon Valley but there's a big world of healthcare hurdles out there. Here are five companies bringing digital health solutions to countries outside the United States.

The potential benefits of digital health for patients in the United States are meaningful: earlier disease detection, better disease management, and overall improved care. 

But in other parts of the world, digital health may be more than a way to improve upon the current healthcare system. As the authors of an August 2016 PwC report, ...

November 23rd, 2016
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Cue

San Diego, CA-based Cue offers an undeniably sleek product that looks like it would fit into the tech-savvy aesthetic of an early adopter's home. According to information on the corporate website, the device tracks patient health indicators for inflammation, vitamin D, fertility, influenza, and testosterone using a nasal swab, saliva, or drop of blood. 

The small device, which company press materials describe as investigational and not for diagnostic use, works with single-use cartridges and sends data to the user via a smartphone app.

In February 2016, ...

November 23rd, 2016
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