FDA Archives - Page 11 of 15 - TMG Pulse

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Drug-delivery FDA Respiratory

B. Braun lands FDA EUA for use of infusion pumps with nebulizers to treat COVID-19

B. Braun Medical announced that it received FDA emergency use authorization to use its infusion pumps […]

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FDA Healthcare Respiratory

TransAeris Diaphragm Pacing System Gets FDA Emergency Use Authorization for Quicker Ventilator Weaning

As hospitals face the possibility of ventilator shortages for COVID-19 patients, Synapse Biomedical announced that […]

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FDA MedTech Respiratory

Device to wean COVID-19 patients off ventilators gains EUA

Dive Brief: A device from Synapse Biomedical to help wean high-risk patients off of mechanical […]

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Cardiology FDA Respiratory

Blood Filtering Device Wins FDA Emergency Use Authorization for COVID-19

The FDA has issued the first Emergency Use Authorization for a device to help treat […]

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Biotech FDA Respiratory

FDA EUAs go to 1st blood purifiers for COVID-19 patients, new N95 mask sterilizers

Dive Brief: FDA has granted its first two emergency use authorizations for extracorporeal blood purification […]

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FDA MedTech Respiratory

Steris wins FDA nod to sterilize used respirators in hospitals

The FDA has granted Steris (NYSE:STE) emergency use authorization (EUA) for a vaporized hydrogen peroxide […]

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Diagnostics FDA MedTech

Over 90% of 1M Abbott coronavirus tests sitting idle, White House official says

Dive Brief: More than 90% of the 1 million Abbott coronavirus tests delivered to laboratories […]

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Digital Health FDA Orthopedic

FDA issues 510(k) for OrthoSensor knee arthroplasty sensor

The FDA issued 510(k) clearance to OrthoSensor for its Verasense sensor-assisted technology, which the company says is […]

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FDA MedTech Vascular

Merit Medical wins FDA breakthrough nods

Merit Medical (NSDQ:MMSI) systems announced that it won two additional breakthrough device designations from the FDA […]

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FDA MedTech

EU permits remote notified body audits during pandemic

Dive Brief: The European Commission’s Medical Device Coordination Group is allowing notified bodies to perform […]

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FDA MedTech Respiratory

Medtronic provides ventilator progress update

Medtronic has announced updates regarding its efforts to increase ventilator production around the globe. The […]

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Diagnostics FDA MedTech

GenMark Diagnostics Sees 80% Revenue Boost in First Quarter

COVID-19 has been tough on companies across many different industries but the current pandemic has […]

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FDA Gastroenterology Implantables

Allurion Files for PMA Submission of Elipse Gastric Balloon

Allurion Technologies is one step closer to having its Elipse gastric balloon enter the U.S. […]

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Cardiology FDA Respiratory

FDA OKs changes to oxygenation devices to treat coronavirus patients

Dive Brief: FDA has relaxed the regulation of extracorporeal membrane oxygenation, or ECMO, devices and […]

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Diagnostics FDA MedTech

Luminex Gains EUA for Diagnostics as Demand for COVID-19 Tests Soars

Luminex can be added to the list of companies that have received Emergency Use Authorization […]

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FDA MedTech Patient Monitoring

FDA allows for infusion pump modifications to prevent shortages

Dive Brief: FDA on Sunday said it will permit limited modifications to previously cleared infusion […]

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FDA MedTech

Coronavirus products or not, medtech navigates shifts in regulatory operations

The U.S. has in recent weeks had no choice but to drop everything to fight […]

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FDA MedTech

How FDA is changing medtech regulation under the coronavirus

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

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FDA Robotics Surgery

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

Neocis announced today that it filed for FDA 510(k) clearance for its Yomi edentulous splint to […]

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Diagnostics FDA Respiratory

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

Forcing manufacturers to repurpose their production lines to make equipment to fight the coronavirus epidemic […]

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Digital Health FDA

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

Dive Brief: FDA on Thursday issued a communication in response to the novel coronavirus outbreak […]

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FDA MedTech Respiratory

FDA OKs anesthesia gas machines as ventilators amid coronavirus shortage fears

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

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Digital Health FDA Radiology

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

Butterfly Network, maker of a handheld, smartphone-connected ultrasound system, has disabled two software features that […]

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FDA MedTech Patient Monitoring

FDA Issues Emergency Guidance for Non-Invasive Remote Monitoring Devices

In an effort to ease remote patient monitoring during the COVID-19 pandemic, FDA has issued […]

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FDA MedTech Neuro

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

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) has […]

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FDA Healthcare Patient Monitoring

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

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

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FDA Healthcare Patient Monitoring

FDA allows expanded use of patient-monitoring devices during pandemic

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

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FDA MedTech

FDA pulls plug on routine US inspections

Dive Brief: FDA is postponing all domestic routine facility inspections in response to the novel […]

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FDA Respiratory

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

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

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Cardiology FDA

TransMedics to get FDA expert review for heart transplant device PMA

Dive Brief: FDA plans to convene a group of circulatory system device experts April 16 […]

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FDA MedTech

BREAKING: FDA postponing all foreign inspections amid coronavirus outbreak

The U.S. FDA said today that it is postponing foreign inspections through April as the […]

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Cardiology FDA

FDA issues Class I recall for Medtronic's HeartWare HVAD after patient death

Dive Brief: FDA issued a Class I device recall notice this week regarding Medtronic’s HeartWare […]

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Drug-delivery FDA

MedTech FDA designates BD's wide-ranging Alaris infusion pump recall as Class I

BD is recalling hundreds of thousands of its Alaris infusion pumps and vital sign monitors […]

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FDA Surgery

FDA updates guidance on 510(k) submissions for electrosurgical devices

Dive Brief: FDA on Monday issued an updated guidance advising manufacturers on how to prepare […]

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FDA Neuro

TMS pioneer Neuronetics gets breakthrough nod, CEO departs

Dive Brief: Neuronetics, the first company to get FDA authorization for a transcranial magnetic stimulation (TMS) […]

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Biotech Cardiology FDA

ClotChip Receives FDA Breakthrough Device Designation for Real-Time Coagulation Testing

Cleveland-based XaTek Inc. announced receiving FDA Breakthrough Device designation for ClotChip, a handheld device that […]

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FDA Urology

iTind for Benign Prostatic Hyperplasia Gets FDA Green Light

Medi-Tate, based in Israel, has won FDA de novo authorization for its iTind system to […]

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Drug-delivery FDA

FDA gives Class I label to BD Alaris infusion pump system recall

Dive Brief: FDA reported Friday that certain infusion pump systems recalled by BD on Feb. 4 […]

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Cardiology FDA

Some pacemakers, EKGs, diabetes devices face newly flagged Bluetooth cyber risk

Dive Brief: FDA is warning that a wide range of medical devices using a wireless […]

Topic: FDA

B. Braun lands FDA EUA for use of infusion pumps with nebulizers to treat COVID-19

TransAeris Diaphragm Pacing System Gets FDA Emergency Use Authorization for Quicker Ventilator Weaning

Device to wean COVID-19 patients off ventilators gains EUA

Blood Filtering Device Wins FDA Emergency Use Authorization for COVID-19

FDA EUAs go to 1st blood purifiers for COVID-19 patients, new N95 mask sterilizers

Steris wins FDA nod to sterilize used respirators in hospitals

Over 90% of 1M Abbott coronavirus tests sitting idle, White House official says

FDA issues 510(k) for OrthoSensor knee arthroplasty sensor

Merit Medical wins FDA breakthrough nods

EU permits remote notified body audits during pandemic

Medtronic provides ventilator progress update

GenMark Diagnostics Sees 80% Revenue Boost in First Quarter

Allurion Files for PMA Submission of Elipse Gastric Balloon

FDA OKs changes to oxygenation devices to treat coronavirus patients

Luminex Gains EUA for Diagnostics as Demand for COVID-19 Tests Soars

FDA allows for infusion pump modifications to prevent shortages

Coronavirus products or not, medtech navigates shifts in regulatory operations

How FDA is changing medtech regulation under the coronavirus

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

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

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

FDA OKs anesthesia gas machines as ventilators amid coronavirus shortage fears

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

FDA Issues Emergency Guidance for Non-Invasive Remote Monitoring Devices

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

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

FDA allows expanded use of patient-monitoring devices during pandemic

FDA pulls plug on routine US inspections

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

TransMedics to get FDA expert review for heart transplant device PMA

BREAKING: FDA postponing all foreign inspections amid coronavirus outbreak

FDA issues Class I recall for Medtronic's HeartWare HVAD after patient death

MedTech FDA designates BD's wide-ranging Alaris infusion pump recall as Class I

FDA updates guidance on 510(k) submissions for electrosurgical devices

TMS pioneer Neuronetics gets breakthrough nod, CEO departs

ClotChip Receives FDA Breakthrough Device Designation for Real-Time Coagulation Testing

iTind for Benign Prostatic Hyperplasia Gets FDA Green Light

FDA gives Class I label to BD Alaris infusion pump system recall

Some pacemakers, EKGs, diabetes devices face newly flagged Bluetooth cyber risk