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

…devices that have at least one component that is additively manufactured or there is an additively fabricated step in the process. “The unique aspects of the AM process, such as…

…devices that have at least one component that is additively manufactured or there is an additively fabricated step in the process. “The unique aspects of the AM process, such as…

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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 Todayā€™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: Itā€™s the Recipe, People

By Dr. Christopher Joseph Devine

compliance with the DMR. Fail to comply with the requirement to provide documented evidence of compliance with the DMR, and the Chief Jailable Officer (CJO) can expect to be on…

compliance with the DMR. Fail to comply with the requirement to provide documented evidence of compliance with the DMR, and the Chief Jailable Officer (CJO) can expect to be on…

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Asia

2017 Update on the Diabetes Market in Asia

By Ames Gross

…spread pollution throughout the region. Western Companies in Asia There are an increasing number of companies manufacturing mobile applications and technology-based “smart” products for the management and treatment of diabetes….

…spread pollution throughout the region. Western Companies in Asia There are an increasing number of companies manufacturing mobile applications and technology-based “smart” products for the management and treatment of diabetes….

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