FDA MedTech

How FDA is changing medtech regulation under the coronavirus

Released on March 31, 2020

The FDA’s Center for Devices & Radiological Health (CDRH) has issued a letter to the medtech industry that outlined the steps […]

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FDA Robotics Surgery

Neocis seeks 510(k) nod for Yomi edentulous splint for robotic dental surgery

Released on March 30, 2020

Neocis announced today that it filed for FDA 510(k) clearance for its Yomi edentulous splint to aid its dental robotic surgical system. […]

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Diagnostics FDA Respiratory

AdvaMed: Invoking Defense Production Act could hinder U.S. medtech imports

Released on March 27, 2020

Forcing manufacturers to repurpose their production lines to make equipment to fight the coronavirus epidemic might actually hurt the U.S. supply […]

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Digital Health FDA

Digital health advice from FDA amid coronavirus leaves more questions than answers

Released on March 27, 2020

Dive Brief: FDA on Thursday issued a communication in response to the novel coronavirus outbreak emphasizing its digital health policies allow […]

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FDA MedTech Respiratory

FDA OKs anesthesia gas machines as ventilators amid coronavirus shortage fears

Released on March 26, 2020

Dive Brief: FDA in an emergency use authorization this week allowed modifications to certain respiratory devices amid fears of a shortage in the […]

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Digital Health FDA Radiology

Butterfly rescinds features from handheld ultrasound device, working with FDA to re-enable

Released on March 25, 2020

Butterfly Network, maker of a handheld, smartphone-connected ultrasound system, has disabled two software features that were implemented on its devices without […]

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FDA MedTech Patient Monitoring

FDA Issues Emergency Guidance for Non-Invasive Remote Monitoring Devices

Released on March 24, 2020

In an effort to ease remote patient monitoring during the COVID-19 pandemic, FDA has issued the temporary guidance, “Enforcement Policy for […]

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FDA MedTech Neuro

CDRH adjusts working practices with medical device companies to deal with COVID-19

Released on March 24, 2020

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) has written to the medical device industry […]

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FDA Healthcare Patient Monitoring

FDA greenlights expanded remote patient monitoring to keep patients out of coronavirus-slammed hospitals

Released on March 20, 2020

Dive Brief: FDA on Friday issued a policy to facilitate greater use of remote patient monitoring technologies to cut back on […]

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FDA Healthcare Patient Monitoring

FDA allows expanded use of patient-monitoring devices during pandemic

Released on March 20, 2020

The FDA announced today that it will allow expanded use of non-invasive remote patient monitoring devices to slow the spread of […]

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FDA MedTech

FDA pulls plug on routine US inspections

Released on March 19, 2020

Dive Brief: FDA is postponing all domestic routine facility inspections in response to the novel coronavirus outbreak, coming one week after […]

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FDA Respiratory

Beyond Air seeks IDE for nitric oxide treatment for COVID-19

Released on March 18, 2020

As companies scramble to develop diagnostic tests and vaccines for COVID-19, there is a need for effective treatments for patients suffering […]

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