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

eMDR’s: No Procedure, Big Problem

By Dr. Christopher Joseph Devine

…can also see what the competition is doing. I believe having knowledge of your competition’s problems can be employed in a simple concept, “Competitive advantage!” In closing, thank you again…

…can also see what the competition is doing. I believe having knowledge of your competition’s problems can be employed in a simple concept, “Competitive advantage!” In closing, thank you again…

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Cybersecurity

ECRI Releases Guidance on Protecting Device Systems Against Ransomware

By MedTech Intelligence Staff

…protective measures that focus specifically on medical device systems versus general hospital systems. ECRI recently released a new guidance, “Ransomware Attacks: How to Protect Your Medical Device Systems”, which offers…

…protective measures that focus specifically on medical device systems versus general hospital systems. ECRI recently released a new guidance, “Ransomware Attacks: How to Protect Your Medical Device Systems”, which offers…

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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

Pharmaceutical companies invest substantially in the development of new, innovative therapies. However, while they spend considerable time and money developing a safe and efficacious drug, many companies do not make…

Pharmaceutical companies invest substantially in the development of new, innovative therapies. However, while they spend considerable time and money developing a safe and efficacious drug, many companies do not make…

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MEDICA

Wanted: Innovative Medical Mobile Solutions for Competition

By MedTech Intelligence Staff

…home €2000, second place wins €1000 and third place takes home €500. To submit a medical mobile solution for the competition, go to http://www.medica.de/mac2. View last year’s winners: https://medtechintelligence.com/news_article/medicas-medical-mobile-app-competition-winners-announced/  …

…home €2000, second place wins €1000 and third place takes home €500. To submit a medical mobile solution for the competition, go to http://www.medica.de/mac2. View last year’s winners: https://medtechintelligence.com/news_article/medicas-medical-mobile-app-competition-winners-announced/  …

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

What, No Inspection Results?

By Dr. Christopher Joseph Devine

…shall be documented. Compliance for Dummies The QSR is eloquently vague in what the FDA is willing to accept as documented evidence when it comes to complying with §820.80(b). However,…

…shall be documented. Compliance for Dummies The QSR is eloquently vague in what the FDA is willing to accept as documented evidence when it comes to complying with §820.80(b). However,…

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Abbott

Abbott Initiates Voluntary Recall of Coronary Catheters

By MedTech Intelligence Staff

…the protective balloon sheath. This issue can cause problems in inflating or deflating the balloon, potentially leading to complications that include air embolism, additional intervention, thrombosis and myocardial infarction. According…

…the protective balloon sheath. This issue can cause problems in inflating or deflating the balloon, potentially leading to complications that include air embolism, additional intervention, thrombosis and myocardial infarction. According…

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