FDA

FDA: Duodenoscope reprocessing is dirtier than we thought

Released on April 12, 2019

The FDA said today that new data show that the contamination rate for …

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FDA Neuro

Magstim wins FDA clearance for faster TMS therapy

Released on April 5, 2019

Magstim has received FDA clearance to include…

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FDA

FDA Eyes Tailored Approach to Regulating AI-Based Medical Devices

Released on April 2, 2019

On Tuesday, Gottlieb said the agency will consider a new regulatory framework for reviewing medical devices that …

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FDA

What a new FDA commissioner could mean for clinical research

Released on April 2, 2019

Dr. Gottlieb introduced a number of initiatives…

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FDA Women's Health

Channel Medsystems wins PMA for Cerene cryoablation device

Released on April 2, 2019

The Cerene device provides gynecologists with the first realistic option for …

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FDA

Apyx Medical withdraws Renuvion FDA 510(k) app for dermal resurfacing indication

Released on April 2, 2019

Apyx Medical said that in reviewing the submission, the FDA had…

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FDA MedTech

Never Underestimate the Power of Communication Skills in Regulatory Affairs

Released on April 1, 2019

Medical device companies are facing more regulatory changes on….

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FDA

Report: Departing FDA head Gottlieb looks back on his time at the agency’s head

Released on April 1, 2019

Though he only held the position for just under two years, FDA Commissioner Dr. Scott Gottlieb said that he believes the agency’s scope has expanded significantly during his time at its head, according to a FierceBiotech report.

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FDA Neuro

New CNS Drug Delivery System by Alcyone Lifesciences Given Breakthrough Designation by FDA

Released on April 1, 2019

Alcyone Lifesciences recently obtained Breakthrough Device Designation from the FDA for their novel implantable intrathecal bolus drug delivery catheter and port system, the ThecaFlex DRx System.

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FDA MedTech

FDA Scrambles to Prevent Shortages Amid Sterilization Shutdowns

Released on March 26, 2019

Shutdowns of two facilities that use ethylene oxide to sterilize medical devices have raised concern about potential shortages in the medtech industry because this is such a popular sterilization method for medical devices.

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FDA MedTech

Another medtech sterilization plant will close in 2019

Released on March 26, 2019

A second medical device sterilization plant is slated to close this year, prompting the FDA and medtech manufacturers to scramble for replacements.

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FDA M&A MedTech

Fresenius Awarded Breakthrough Device Designation for Software

Released on March 15, 2019

Fresenius Medical Care hit a significant milestone last week with its software to enhance its line of hemodialysis machines.

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FDA MedTech

FDA Wants to Take a Hard Look at Medical Devices Materials

Released on March 15, 2019

FDA is calling on the public, scientists, and industry to help enhance the agency’s understanding of materials science and to advance the development of safer medical device materials.

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