Alert

Failing to Properly Clean, Disinfect and Sterilize Devices Among Top Patient Hazards

By MedTech Intelligence Staff

Medical device reprocessing is a common practice in hospitals and other healthcare facilities. The practice can save costs and prevent more waste from entering landfills. However, when devices are not…

Medical device reprocessing is a common practice in hospitals and other healthcare facilities. The practice can save costs and prevent more waste from entering landfills. However, when devices are not…

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Theranos

SEC Charges Theranos CEO Elizabeth Holmes with Fraud, Stripped of Control of Company

By MedTech Intelligence Staff

…could only complete a small number of tests. In fact, “the company conducted the vast majority of patient tests on modified and industry-standard commercial analyzers manufactured by others,” according to…

…could only complete a small number of tests. In fact, “the company conducted the vast majority of patient tests on modified and industry-standard commercial analyzers manufactured by others,” according to…

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Brian Moan, Norman Rabin, Maetrics
Soapbox

IVDR signals In Vitro Industry Shake-up

By Brian Moan, Norman Rabin

coming under pressure from their Competent Authorities (CAs) to increase scrutiny of their client IVD medical device manufacturers. Not only this, but NBs will themselves need to seek designation under…

coming under pressure from their Competent Authorities (CAs) to increase scrutiny of their client IVD medical device manufacturers. Not only this, but NBs will themselves need to seek designation under…

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

Duodenoscopes Take Two

By Dr. Christopher Joseph Devine

…820 Compliance. Charleston, SC: Amazon. FDA. (March 2018). Inspections, Compliance, Enforcement, and Criminal Investigations. Hoya Corp. – Pentax Life Division. Accessed March 11, 2018. Retrieved from https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm600342.htm. FDA. (March 2018)….

…820 Compliance. Charleston, SC: Amazon. FDA. (March 2018). Inspections, Compliance, Enforcement, and Criminal Investigations. Hoya Corp. – Pentax Life Division. Accessed March 11, 2018. Retrieved from https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm600342.htm. FDA. (March 2018)….

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Bang Chau, Innovit

Embrace the Healthcare Data Transformation

By Bang Chau

community is by adopting healthcare industry standards such as: GS1, HBICC or ISBT for product identification GDSN for synchronization of supply chain and commercial data HL7/SPL for submitting UDI and…

community is by adopting healthcare industry standards such as: GS1, HBICC or ISBT for product identification GDSN for synchronization of supply chain and commercial data HL7/SPL for submitting UDI and…

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Ames Gross, Pacific Bridge Medical
Ameing for Asia

Strategies for Success in Japanā€™s Medical Device Market

By Ames Gross

…whether these companies were qualified. The impetus for choosing this Japanese trading company was the fact that this trading company was going to invest $5 million in the client’s company,…

…whether these companies were qualified. The impetus for choosing this Japanese trading company was the fact that this trading company was going to invest $5 million in the client’s company,…

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FDA

Abbott Wins FDA Approval for Worldā€™s Smallest Mechanical Heart Valve

By MedTech Intelligence Staff

Today FDA announced that it has expanded approval of Abbott’s Masters Series Mechanical Heart Valve to include a size small enough to treat newborns. The 15-mm Hemodynamic Plus valve provides…

Today FDA announced that it has expanded approval of Abbott’s Masters Series Mechanical Heart Valve to include a size small enough to treat newborns. The 15-mm Hemodynamic Plus valve provides…

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Rich Denness, North Highland
Soapbox

Turning Internal Challenges into Customer Opportunities

By Rich Denness

…2018: Healthcare and Life Sciences. In North Highland. Retrieved from http://www.northhighland.com/insights/thought-leadership/north-highland-beacon-healthcare Shah, S. (2017, August 31). FDA recalls close to half-a-million pacemakers over hacking fears. In Engadget. Retrieved from https://www.engadget.com/2017/08/31/fda-pacemakers-abbott-hacking/…

…2018: Healthcare and Life Sciences. In North Highland. Retrieved from http://www.northhighland.com/insights/thought-leadership/north-highland-beacon-healthcare Shah, S. (2017, August 31). FDA recalls close to half-a-million pacemakers over hacking fears. In Engadget. Retrieved from https://www.engadget.com/2017/08/31/fda-pacemakers-abbott-hacking/…

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Optical imaging, rice university

Wearable Microscopes Could Eliminate Biopsies and Blood Tests

By MedTech Intelligence Staff

…by Vivek Boominathan/Rice University) The technology will use computational scatterography, a combination of mathematical algorithms, camera design and imaging sensors that will allow them to reverse engineer the scattered light…

…by Vivek Boominathan/Rice University) The technology will use computational scatterography, a combination of mathematical algorithms, camera design and imaging sensors that will allow them to reverse engineer the scattered light…

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