In a new report, Public Citizen rails against a legislative proposal in the 21st Century Cures Act that would encourage FDA to approve high-risk medical devices based only on data published in peer-reviewed journals.

Marie Thibault

Public Citizen opposes a proposal to encourage FDA approval of high-risk medical devices using just peer-reviewed journal data.

The advocacy group has released a report outlining its objections to a section of the 21st Century Cures Act that would specifically include studies in peer-reviewed journals as "valid scientific evidence" suitable for FDA to determine device effectiveness.

According to its report, "A...

February 11th, 2016
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The FDA's evolution on digital health is on the back of interesting encounters with digital health pioneers. Here's one. 

Arundhati Parmar

When you are a digital health company to get one of the first FDA clearances for your mobile prescription therapy, you are bound to have a heck of a story.

And that is true of WellDoc, the company that has developed a software tool to help type 2 diabetes patients manage their disease. The solution is prescribed by physicians, activated by pharmacies and treated like a pharmacy benefit. FDA blessed it earliest version...

February 10th, 2016
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One tax expert thinks the two-year suspension of the device excise tax likely heralds further suspensions or a repeal.

Marie Thibault

Will it stay or will it go? That's been the question since the two-year suspension of the medical device excise tax was announced in late 2015.

One tax expert believes that the device tax won't be back. Michael Cronin, senior manager, New England state and local indirect tax and national medical device excise tax leader, at Grant Thornton LLP, called the tax suspension "the camel's nose in the tent." The suspension "hopefully allows bigger things, allows the camel in the tent, and hopefully this is repealed," he said.

Cronin was speaking on a webinar, ...

February 10th, 2016
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Regulatory shifts, as well as a focus on device usability and connected devices, are changing research and development processes for the medical device industry.

George I’ons and Gareth Walker

The medical device design and manufacturing industry needs to innovate and evolve to meet today’s demands and regulations. The regulatory landscape will continue to impact medical device design and manufacturing. For example, the ramifications of a broadening understanding of what qualifies as a “combination product” will continue to affect the industry. Devices which have traditionally been viewed as a separate drug and device are now being perceived as combination products: an active pharmaceutical ingredient and a medical device are seen as...

February 10th, 2016
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Grocery retailers like Safeway are getting into the healthcare game by offering lab tests at certain select locations, underscoring the trend of consumer-driven healthcare. 

Arundhati Parmar

 

The morphing of CVS to CVS Health and Walgreens' multi-pronged effort in healthcare, including its recent plan to combat prescription drug abuse, underscores the growing trend of consumerization of healthcare.

In states like Arizona, that mega trend, along with a unique law passed to encourage people to be involved in their own health, has created opportunities for traditional grocery chains like Safeway to get into the...

February 9th, 2016
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Medicare's final decision memo on reimbursement coverage for percutaneous left atrial appendage closure therapy is more forgiving than its November proposal. Here's what that means for Boston Scientific's Watchman device.

Marie Thibault

It's a win for Boston Scientific's Watchman device.

CMS released its decision memo on percutaneous left atrial appendage closure (LAAC) therapy on Monday with revised criteria for reimbursement coverage. Notably, the...

February 9th, 2016
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South Africa

Domestic Market: $1.1 billion (2015)

Exports: $40.6 billion (2013)

Major Export Markets: Zimbabwe, Kenya

Local Players: MDG Health Solutions, Akacia Healthcare, Southern Medical, Respitek

Regulatory Body: Department of Health

Stat: ...

February 5th, 2016
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India

Domestic Market: $3.5 billion (2015)

Exports: $1.1 billion (2015)

Major Export Markets: UAE, United States, China, Singapore, Hong Kong

Local Players: TTK Healthcare, Appasamy Associates, Trivitron Healthcare, Aravind Eye Care

Regulatory Body: Central Drugs Standard Control Organization

Stat: There are nearly 1000 local medical device companies operating in...

February 5th, 2016
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Mexico

Domestic Market: $4.0 billion (2015)

Exports: $8.6 billion (2011)

Major Export Markets: United States, Latin America

Local Players: Compañía Mexicana de Radiología, Semka Technologies 

Regulatory Body: Federal Commission for Protection Against Sanitary Risks (COFEPRIS)

Stat: Medical device comapnies operating in...

February 5th, 2016
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Turkey

Domestic Market: $2.6 billion (2015)

Exports: $224 million (2015)

Major Export Markets: Iran, Azerbaijan, Germany, China

Local Players: UZUMCU Medical Equipment 

Regulatory Body: General Directorate of Pharmaceuticals and Pharmacy Department of Medical Device...

February 5th, 2016
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