Medtech question

Themes of Risk and Uncertainty Continue for 2018

By Maria Fontanazza

…three recommendations that industry should heed in addressing cybersecurity risks. Hospitals and device companies should invest in proactive steps, including conducting tests for cybersecurity breaches and remediation measures. This includes…

…three recommendations that industry should heed in addressing cybersecurity risks. Hospitals and device companies should invest in proactive steps, including conducting tests for cybersecurity breaches and remediation measures. This includes…

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Edwards Lifesciences

Edwards Lifesciences Eyes $4 Billion Mark for 2018, Acquires Harpoon Medical

By MedTech Intelligence Staff

…$100 million in cash for the company. “The unique beating-heart repair procedure for mitral valve patients complements Edwards’ comprehensive portfolio of treatments for structural heart disease, and reinforces our commitment…

…$100 million in cash for the company. “The unique beating-heart repair procedure for mitral valve patients complements Edwards’ comprehensive portfolio of treatments for structural heart disease, and reinforces our commitment…

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Ames Gross, Pacific Bridge Medical
Ameing for Asia

Following Trump to Asia

By Ames Gross

…full frontal attack by Chinese medtech companies. On the regulatory front, on November 8, 2017, new regulations from the Chinese government will help Western medical companies have more success in…

…full frontal attack by Chinese medtech companies. On the regulatory front, on November 8, 2017, new regulations from the Chinese government will help Western medical companies have more success in…

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Alert

Patient Danger: Ransomware and Cybersecurity a Top Concern

By MedTech Intelligence Staff

This year cybersecurity and ransomware have been a significant issue across all industries. Now ECRI is alerting the healthcare industry to the potential danger that ransomware and malware pose to…

This year cybersecurity and ransomware have been a significant issue across all industries. Now ECRI is alerting the healthcare industry to the potential danger that ransomware and malware pose to…

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FDA

FDA Issues Final Guidance for 3-D Printing

By MedTech Intelligence Staff

Today FDA issued the final version of its guidance on additive manufacturing. “Technical Considerations for Additive Manufactured Medical Devices” makes recommendations regarding device design, manufacturing and testing considerations when developing…

Today FDA issued the final version of its guidance on additive manufacturing. “Technical Considerations for Additive Manufactured Medical Devices” makes recommendations regarding device design, manufacturing and testing considerations when developing…

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

Tanning Beds are Medical Devices, Who Knew?

By Dr. Christopher Joseph Devine

…Devine, C. (2013). Devine guidance for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (October 2017). Inspections, Compliance, Enforcement,…

…Devine, C. (2013). Devine guidance for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (October 2017). Inspections, Compliance, Enforcement,…

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K. Lance Anderson

The Patent Mirage: The New Challenge for Today’s IP Strategy

By K. Lance Anderson

…Over the years, businesses that participate in research and development or improvements to goods and services have implemented best practices when it comes to protecting their intellectual property assets. Effective…

…Over the years, businesses that participate in research and development or improvements to goods and services have implemented best practices when it comes to protecting their intellectual property assets. Effective…

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Sara Dyson, Medmarc

Medical Device Software & Products Liability: The Homefront (Part II)

By Sara E. Dyson, Esq.

…Occupational Outlook Handbook, “Home Health Aides,” June 22, 2017, see www.bls.gov/ooh/healthcare/home-health-aides.htm. See https://www.bls.gov/emp/ep_table_104.htm. Telemedicine statistics are from “How Telemedicine Is Transforming Health Care,” The Wall Street Journal, June 26, 2016…

…Occupational Outlook Handbook, “Home Health Aides,” June 22, 2017, see www.bls.gov/ooh/healthcare/home-health-aides.htm. See https://www.bls.gov/emp/ep_table_104.htm. Telemedicine statistics are from “How Telemedicine Is Transforming Health Care,” The Wall Street Journal, June 26, 2016…

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

The DMR: It’s the Recipe, People

By Dr. Christopher Joseph Devine

…key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA’s enforcement page. (2017, October). FDA.gov Website. Retrieved November 13, 2017, From https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm580281.htm…

…key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA’s enforcement page. (2017, October). FDA.gov Website. Retrieved November 13, 2017, From https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm580281.htm…

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Stephanie Kute, Battelle

How “Big Data” Enabled a Paralyzed Man to Move His Arm

By Stephanie Kute

…data sets. Instead of providing explicit directions to follow, a computer scientist feeds the program with large sets of training data. For example, an image interpretation program can be trained…

…data sets. Instead of providing explicit directions to follow, a computer scientist feeds the program with large sets of training data. For example, an image interpretation program can be trained…

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