Maquet Getinge, Datascope

Following Patient Death, Datascope Performs Field Correction of Intra-Aortic Balloon Pumps

By MedTech Intelligence Staff

Datascope Corp. is performing a voluntary global field correction of certain intra-aortic balloon pumps (IABP). The company received a complaint that an electrical test failure code #58 cause a device…

Datascope Corp. is performing a voluntary global field correction of certain intra-aortic balloon pumps (IABP). The company received a complaint that an electrical test failure code #58 cause a device…

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Stryker, Novadaq

Stryker Improves Surgical Imaging with Novadaq Acquisition

By MedTech Intelligence Staff

On Monday Stryker Corp. announced its intent to acquire Canada-based Novadaq Technologies, Inc. for $701 million. The definitive agreement beefs up Stryker’s product portfolio in open and plastic reconstructive surgery,…

On Monday Stryker Corp. announced its intent to acquire Canada-based Novadaq Technologies, Inc. for $701 million. The definitive agreement beefs up Stryker’s product portfolio in open and plastic reconstructive surgery,…

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Wearable Cloud, Medical Device Connectivity

FDA Sets Forth Digital Health Innovation Plan

By MedTech Intelligence Staff

…to technologies in digital health in a more concrete way: It established a new initiative, the Digital Health Innovation Plan. Announced by FDA Commissioner Scott Gottlieb, M.D. on the agency’s…

…to technologies in digital health in a more concrete way: It established a new initiative, the Digital Health Innovation Plan. Announced by FDA Commissioner Scott Gottlieb, M.D. on the agency’s…

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Medtech, innovation

Microfluidics Brings the Modern Lab to Point of Care

By Klaus Jopp

…said Henne van Heeren of EnablingMNT (Dordrecht, Netherlands), a company that provides marketing and strategic support for the micro and nanotechnology industries. Prime locations for the commercialization of microfluidics include…

…said Henne van Heeren of EnablingMNT (Dordrecht, Netherlands), a company that provides marketing and strategic support for the micro and nanotechnology industries. Prime locations for the commercialization of microfluidics include…

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Duodenoscope, ECRI

510(k)s for Reusable Devices Must Include Validated Data for Cleaning in IFUs

By MedTech Intelligence Staff

…make it more difficult to reprocess instruments and accessories, such as lumens, hinges, shafts with lumens, crevices, ridges or grooves, porous materials, internal movable device components and features that may…

…make it more difficult to reprocess instruments and accessories, such as lumens, hinges, shafts with lumens, crevices, ridges or grooves, porous materials, internal movable device components and features that may…

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

Recall, That Nasty 6-Letter Word!

By Dr. Christopher Joseph Devine

obtained by visiting the FDA’s website. Compliance for Dummies As the doctor previously mentioned, when in doubt, it is an acceptable practice to contact FDA and obtain their concurrence when…

obtained by visiting the FDA’s website. Compliance for Dummies As the doctor previously mentioned, when in doubt, it is an acceptable practice to contact FDA and obtain their concurrence when…

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FDA

21st Century Cures Act: FDA Amends Certain HDE and IRB Requirements

By MedTech Intelligence Staff

…measures and policies to protect patients who are involved in clinical research or are treated with HDE devices,” FDA stated in a release. The changes are effective June 7, 2017….

…measures and policies to protect patients who are involved in clinical research or are treated with HDE devices,” FDA stated in a release. The changes are effective June 7, 2017….

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Ameing for Asia

China Taking Over the World Quickly!

By Ames Gross

…China and other countries along the way, planning to build new railroads and highways between China, Europe and Africa. Once completed, this Silk Road will provide direct access to many…

…China and other countries along the way, planning to build new railroads and highways between China, Europe and Africa. Once completed, this Silk Road will provide direct access to many…

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Edwards Sapien 3 transcatheter valve

FDA Approves Expanded Use of Sapien 3 for Valve-in-Valve Treatment

By MedTech Intelligence Staff

for use in patients who are at high or greater risk of complications from repeat surgery, said Bram Zuckerman, M.D., director of the division of cardiovascular devices at CDRH in…

for use in patients who are at high or greater risk of complications from repeat surgery, said Bram Zuckerman, M.D., director of the division of cardiovascular devices at CDRH in…

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Richard Satava, M.D.
MEDdesign

Surgical Energy: The Future and The Opportunity

By Richard M. Satava, M.D.

…of its use and its complication rates by those who championed the new technology were then challenged when the new technique became more popular among those who didn’t have the…

…of its use and its complication rates by those who championed the new technology were then challenged when the new technique became more popular among those who didn’t have the…

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