Ames Gross, Pacific Bridge Medical
Ameing for Asia

High Demand for Breast Cancer Diagnosis and Treatment Products in Asia

By Ames Gross

…BluePrint Molecular Subtyping test helps determine the best course of treatment for patients by evaluating how well a particular cancer is likely to respond to chemotherapy. Medical Device Companies Bring…

…BluePrint Molecular Subtyping test helps determine the best course of treatment for patients by evaluating how well a particular cancer is likely to respond to chemotherapy. Medical Device Companies Bring…

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MDSAP, Medical Device Single Audit Program

You can do it! Nailing Your MDSAP Audit and Sustaining Long-Term Compliance

By Kate Leith

example, if an AO auditor is examining Receiving and Inspection, he/she may ask about process inputs such as where the testing methods and specifications originate. The answer is likely Design,…

example, if an AO auditor is examining Receiving and Inspection, he/she may ask about process inputs such as where the testing methods and specifications originate. The answer is likely Design,…

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Jothy Rosenberg, Dover Microsystems
MEDdesign

A Security Epidemic: The Internet of (insecure) Things and the Risk to Medical Devices

By Jothy Rosenberg

…to attacks. This fact, combined with processors that can’t defend themselves, makes software and those connected medical devices a ticking time bomb. Fortunately, there is hope. A combination of regulations,…

…to attacks. This fact, combined with processors that can’t defend themselves, makes software and those connected medical devices a ticking time bomb. Fortunately, there is hope. A combination of regulations,…

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Apple logo

Apple Watch 4 Gets FDA Clearance

By MedTech Intelligence Staff

In addition to all the bells and whistles that come with an Apple Watch, the Series 4 product has received FDA clearance—specifically De Novo classification. Unveiled at an Apple event…

In addition to all the bells and whistles that come with an Apple Watch, the Series 4 product has received FDA clearance—specifically De Novo classification. Unveiled at an Apple event…

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FDA

FDA Awards $6 Million in Grants for Pediatric Device Development

By MedTech Intelligence Staff

…medical devices.” – Scott Gottlieb, M.D., FDA The consortia will provide expertise to device developers in a range of areas, including intellectual property, engineering, prototyping, lab testing and clinical trial…

…medical devices.” – Scott Gottlieb, M.D., FDA The consortia will provide expertise to device developers in a range of areas, including intellectual property, engineering, prototyping, lab testing and clinical trial…

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Operating Room Integration

Operating Room Integration System Market to Grow Alongside Rising Demand for Minimally Invasive Surgeries and Need for Good Quality Care

By Sharmistha Sarkar

Today’s operating rooms are congested, complex and inefficient. A multitude of advanced technologies and devices such as surgical displays, communication system monitors, lights, camera systems, image capturing devices, and others…

Today’s operating rooms are congested, complex and inefficient. A multitude of advanced technologies and devices such as surgical displays, communication system monitors, lights, camera systems, image capturing devices, and others…

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Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

Big Butts, Take Three!

By Dr. Christopher Joseph Devine

…some sort of mystical allure to having a large derriere (look-it-up). Considering the well-publicized risks associated with illegal injections versus knowing that the only well-known death associated with the consumption…

…some sort of mystical allure to having a large derriere (look-it-up). Considering the well-publicized risks associated with illegal injections versus knowing that the only well-known death associated with the consumption…

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Asia

Expanding Hospital Markets in Asia Provides Opportunities for MedTech Manufacturers: The Hospital Markets in India and Southeast Asia (Part II)

By Ames Gross

…just $267 per year, compared to $730 in China and $1318 in Brazil in 2015, according to the World Health Organization. The overall healthcare sector is expected to surge to…

…just $267 per year, compared to $730 in China and $1318 in Brazil in 2015, according to the World Health Organization. The overall healthcare sector is expected to surge to…

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FDA

FDA Issues Draft Guidance on Considerations of Uncertainty in Making Benefit-Risk Determinations for Premarket Decisions

By MedTech Intelligence Staff

…release. The draft explains the agency’s consideration of uncertainty “when determining benefit-risk for certain premarket decisions on medical devices based on the totality of the valid scientific evidence,” FDA states….

…release. The draft explains the agency’s consideration of uncertainty “when determining benefit-risk for certain premarket decisions on medical devices based on the totality of the valid scientific evidence,” FDA states….

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Theranos

ā€œWe Are Now Out of Timeā€: Theranos to Dissolve

By MedTech Intelligence Staff

…letter to company stockholders. He went on to state that the company is in default and owes at least $60 million to its unsecured creditors. The company has already started…

…letter to company stockholders. He went on to state that the company is in default and owes at least $60 million to its unsecured creditors. The company has already started…

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