Author Archives: admin

Too Many “Loopholes” – Says FDA Device Chief

Jeffrey Shuren, director of FDA’s Center for Devices and Radiological Health (CDRH) stated that the Agency lacks sufficient power to block unsafe products.  A new bill not endorsed by Shren, tabled by the House Democrats will allow FDA to reject … Continue reading

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Globus Medical To Settle For $1 Million With FDA

A settlement has been reached between the FDA and Globus Medical Inc with regards to the Distribution of NuBone Osteoinductive Bone Graft prior to reaching proper premarket approval. Globus Medical Inc. alleged that it maintained “open communication” with FDA and … Continue reading

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Economy Having Impact on Medical Device Firms

Low patient volumes and pricing pressures will keep same-facility aggregate EBITDA growth in the low-single digits (percentage) for the next 12 to 18 months says Moody’s.  This will impact device and manufactures who are expected to have EBITDA growth to … Continue reading

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NHS Reforms Should be Stopped – says Radiologists

The majority of members of the Royal College of Radiologists says NHS reforms should be abandoned.  The college said 76% of its members – which include cancer specialists called for England’s NHS withdrawal of the plans to reform the health … Continue reading

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Metal-on-Metal Hip Replacement Advice From MHRA

Metal-on-metal hip replacements with head diameters of 36 mm or more need to be monitored every year of the life of the replacement says Medicines and Healthcare products Regulatory Agency (MHRA). The updated advice was given to surgeons as a … Continue reading

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Law to Force Women to Have an Ultrasound Prior to Abortion

Amendments to a law that will require all women having an abortion to get an ultrasound beforehand has been sent to Virginia’s Republican governor for approval. In addition to Virginia, six other states have similar laws. The law will require … Continue reading

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Sterigenics Sells for $675 Million

An announcement was made – that Silverfleet Capital sold Sterigenics for $675 Million to equity group GTCR. The announcement said that the sale will close on the second quarter.

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Medical Device School – Blog

Welcome to our Blog.  We hope to provide the medical device community with great content.  Please keep checking!

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