FDA

FDA Releases Draft Guidance for Multiple Function Devices

By MedTech Intelligence Staff

FDA has issued a draft guidance to clear up its policy for products that have more than one function. The draft, Multiple Function Device Products: Policy and Considerations; Draft Guidance…

FDA has issued a draft guidance to clear up its policy for products that have more than one function. The draft, Multiple Function Device Products: Policy and Considerations; Draft Guidance…

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Alert

FDA Restricts Sale of Bayer’s Essure

By MedTech Intelligence Staff

…before getting the device implanted, despite previous significant efforts to educate patients and doctors about the risks associated with this device.” – FDA According to an FDA news release, since…

…before getting the device implanted, despite previous significant efforts to educate patients and doctors about the risks associated with this device.” – FDA According to an FDA news release, since…

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MedTech Intelligence

Cybersecurity: How Vulnerable Are You?

By MedTech Intelligence Staff

Both hospitals as well as medical device manufacturers are vulnerable to the threats posed by bad actors. Ensuring the security of medical software is of paramount importance, but there are…

Both hospitals as well as medical device manufacturers are vulnerable to the threats posed by bad actors. Ensuring the security of medical software is of paramount importance, but there are…

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

When Furry Critters Aren’t So Cute

By Dr. Christopher Joseph Devine

…provided. Until the next installment of DG, cheers from Dr. D., and best wishes for continued professional success. Find the fake news: This article is part of the Food Safety…

…provided. Until the next installment of DG, cheers from Dr. D., and best wishes for continued professional success. Find the fake news: This article is part of the Food Safety…

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FDA

FDA Allows Marketing of First Interoperable Continuous Glucose Monitoring System

By MedTech Intelligence Staff

…devices used for diabetes management,” FDA stated in a news release. “Today’s authorization also classifies this new type of device in class II and subjects it to certain criteria called…

…devices used for diabetes management,” FDA stated in a news release. “Today’s authorization also classifies this new type of device in class II and subjects it to certain criteria called…

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Rice University, Diabetic foot

Device Helps Patients Detect Early Signs of Ulceration

By MedTech Intelligence Staff

…telescoping stick. Patients would then manually inspect their feet. Find the fake news: This article is part of the MedTech Intelligence April Fool’s edition. To find out which stories are…

…telescoping stick. Patients would then manually inspect their feet. Find the fake news: This article is part of the MedTech Intelligence April Fool’s edition. To find out which stories are…

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Medical device recall

BD Recalls Vacutainer Blood Collection Tubes Due to Chemical Interference

By MedTech Intelligence Staff

Last week BD announced a Class I recall of its Vacutainer EDTA Blood Collection Tubes with lavender, tan, pink and green rubber tube stoppers. A chemical in the stopper interferes…

Last week BD announced a Class I recall of its Vacutainer EDTA Blood Collection Tubes with lavender, tan, pink and green rubber tube stoppers. A chemical in the stopper interferes…

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Japan

Japan a Major Player, But Be Prepared

By Maria Fontanazza

…documents to obtain approval, so a great deal of diligence and attention to detail is required. The good news is that Japan is more transparent than some other Asian markets…

…documents to obtain approval, so a great deal of diligence and attention to detail is required. The good news is that Japan is more transparent than some other Asian markets…

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Alert

Failing to Properly Clean, Disinfect and Sterilize Devices Among Top Patient Hazards

By MedTech Intelligence Staff

Medical device reprocessing is a common practice in hospitals and other healthcare facilities. The practice can save costs and prevent more waste from entering landfills. However, when devices are not…

Medical device reprocessing is a common practice in hospitals and other healthcare facilities. The practice can save costs and prevent more waste from entering landfills. However, when devices are not…

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