Medical device recall

High Fracture Rate: Zimmer Biomet Recalls Reverse Shoulder

By MedTech Intelligence Staff

Today FDA released an announcement that Zimmer Biomet is recalling its Comprehensive Reverse Shoulder due to a high fracture rate. This device issue can lead to adverse events, including permanent…

Today FDA released an announcement that Zimmer Biomet is recalling its Comprehensive Reverse Shoulder due to a high fracture rate. This device issue can lead to adverse events, including permanent…

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Heart

Was Device Tax Responsible for 29k Job Loss?

By MedTech Intelligence Staff

…the U.S. medtech industry lost 28,834 jobs—a 7.2% decrease. The majority of job losses were seen in 2014, with the industry losing about 27,000 positions in the industry.   https://medtechintelligence.com/news_article/trumps-impact-pricing-rd-funding-cybersecurity-among-top-trends-new-year/…

…the U.S. medtech industry lost 28,834 jobs—a 7.2% decrease. The majority of job losses were seen in 2014, with the industry losing about 27,000 positions in the industry.   https://medtechintelligence.com/news_article/trumps-impact-pricing-rd-funding-cybersecurity-among-top-trends-new-year/…

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Establishing a Medical Device Presence in China? Be Very Careful

By Ames Gross

…marketing and sales. This company wanted us to work with the local government executives to maximize benefits and incentives that foreign device company could possibly get for their new operations…

…marketing and sales. This company wanted us to work with the local government executives to maximize benefits and incentives that foreign device company could possibly get for their new operations…

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Footsteps

Remediation: Risk Priorities

By Maria Fontanazza

…widespread in the standards community, and certainly, there are many types of risk. However, the different risks being considered and addressed by various stakeholders can create regulatory problems if it…

…widespread in the standards community, and certainly, there are many types of risk. However, the different risks being considered and addressed by various stakeholders can create regulatory problems if it…

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Allergan

Allergan to Buy Zeltiq Aesthetics for Nearly $2.5 Billion

By MedTech Intelligence Staff

Today Allergan announced its intention to acquire California-based medical aesthetics company Zeltiq Aesthetics, Inc. Zeltiq manufactures products that use its patented cooling technology, most notably the CoolSculpting System, which is…

Today Allergan announced its intention to acquire California-based medical aesthetics company Zeltiq Aesthetics, Inc. Zeltiq manufactures products that use its patented cooling technology, most notably the CoolSculpting System, which is…

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

Misbranded Lap Bands & Prison, What a Tale!

By Dr. Christopher Joseph Devine

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

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

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Footsteps

Remediation: Considerations During the Process

By Maria Fontanazza

…the fundamental considerations during remediation. MedTech Intelligence: What key points should device companies consider during remediation? Mark Leimbeck: Infrastructure If your company needs to generate information for legacy devices, you…

…the fundamental considerations during remediation. MedTech Intelligence: What key points should device companies consider during remediation? Mark Leimbeck: Infrastructure If your company needs to generate information for legacy devices, you…

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

Rodents in the Workforce, Oh My!

By Dr. Christopher Joseph Devine

…(2013). Devine guidance for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (July 2016). Inspections, Compliance, Enforcement, and Criminal…

…(2013). Devine guidance for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (July 2016). Inspections, Compliance, Enforcement, and Criminal…

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Medtronic, CardioInsight

Medtronic Wins FDA Clearance for First Noninvasive Cardiac Electrical Mapping System

By MedTech Intelligence Staff

…is providing the first commercial noninvasive solution for this approach with the CardioInsight Noninvasive 3D Mapping System. The technology received 510(k) approval from FDA and can be used to map…

…is providing the first commercial noninvasive solution for this approach with the CardioInsight Noninvasive 3D Mapping System. The technology received 510(k) approval from FDA and can be used to map…

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