Ameing for Asia

China Taking Over the World Quickly!

By Ames Gross

…can we compete with China by acting this way? China is also interested in dominating the global medical device business. Chinese device companies can make almost all the Western device…

…can we compete with China by acting this way? China is also interested in dominating the global medical device business. Chinese device companies can make almost all the Western device…

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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.

…Clin Neurosci. 7(3): 187–194. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4981830/. Vaezy, S., et al. (March 1999). Use of high-intensity focused ultrasound to control bleeding. Journal of Vascular Surgery. 29(3): 533–542. Retrieved from http://www.sciencedirect.com/science/article/pii/S074152149970282X…

…Clin Neurosci. 7(3): 187–194. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4981830/. Vaezy, S., et al. (March 1999). Use of high-intensity focused ultrasound to control bleeding. Journal of Vascular Surgery. 29(3): 533–542. Retrieved from http://www.sciencedirect.com/science/article/pii/S074152149970282X…

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Zimmer Biomet, spinal stimulator recall

Toxic? Zimmer Biomet Recalls Implantable Spinal Fusion Stimulators

By MedTech Intelligence Staff

…into the back and provide constant electrical stimulation to increase the possibility of permanently fusing two or more bones of the spine. However, during the company’s routine monitoring procedures, it…

…into the back and provide constant electrical stimulation to increase the possibility of permanently fusing two or more bones of the spine. However, during the company’s routine monitoring procedures, it…

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

eMDRā€™s: No Procedure, Big Problem

By Dr. Christopher Joseph Devine

…– 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. ( May 2017). Inspections, Compliance, Enforcement, and Criminal Investigations. International Medsurg Connection, Inc. Accessed May 22, 2017. Retrieved from https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm558368.htm…

…– 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. ( May 2017). Inspections, Compliance, Enforcement, and Criminal Investigations. International Medsurg Connection, Inc. Accessed May 22, 2017. Retrieved from https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm558368.htm…

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Cybersecurity

ECRI Releases Guidance on Protecting Device Systems Against Ransomware

By MedTech Intelligence Staff

Ransomware attacks are making headlines with increased frequency. The latest malware to affect medical devices, WannaCry, wreaked havoc on hospitals in the U.K. and hit at least two hospital systems…

Ransomware attacks are making headlines with increased frequency. The latest malware to affect medical devices, WannaCry, wreaked havoc on hospitals in the U.K. and hit at least two hospital systems…

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Asia

Smaller Economies in Asia to Boost MedTech Market

By Ames Gross

…Conclusion While the healthcare markets discussed in this article are tiny compared to Japan and China, they are growing quickly, and when combined include more than 562 million people. Device…

…Conclusion While the healthcare markets discussed in this article are tiny compared to Japan and China, they are growing quickly, and when combined include more than 562 million people. Device…

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Medical device recall

Abbott-Thoratec Recalls HeartMate II Following 26 Deaths

By MedTech Intelligence Staff

…and software. An Abbott spokeperson stated in an email, “No products are being retrieved in this case; rather, the focus is on communication to physicians so they can ensure their…

…and software. An Abbott spokeperson stated in an email, “No products are being retrieved in this case; rather, the focus is on communication to physicians so they can ensure their…

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Philips Respironics

Respironics Recalls Ventilator Due to Unexpected Shutdown

By MedTech Intelligence Staff

…safety alert. The Class I recall affects V60 ventilators manufactured between April 2, 2009 and September 15, 2015. According to the FDA recall database, there are 30,516 units in commerce….

…safety alert. The Class I recall affects V60 ventilators manufactured between April 2, 2009 and September 15, 2015. According to the FDA recall database, there are 30,516 units in commerce….

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Combination product, human factors

Optimize Combination Products: Select a Drug Delivery Device that Meets User Needs

By Allison Strochlic, Erin Davis

company’s ability to get an important drug to market. Given this pattern, pharmaceutical companies are well-served to select a device that is not only compatible with the drug, but that…

company’s ability to get an important drug to market. Given this pattern, pharmaceutical companies are well-served to select a device that is not only compatible with the drug, but that…

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