Submissions and Approvals

FDA Clears ivWatch’s Disposable Sensor for IV Infiltration Detection

July 10, 2020

The sensor notifies clinicians in real-time of tissue changes that could indicate a potential infiltration of the IV. Read More

Balt’s Flow Diverting Stent Receives CE Mark

July 10, 2020

The device is easily visible under angiography. Read More

Nonin Medical’s Portable Measurement Device Cleared

July 10, 2020

The wireless device can simultaneously track a patient’s pulse rate, blood oxygen and carbon monoxide levels, among other measurements. Read More

DiaSorin Earns CE Mark for Flu Assay to Run with COVID-19 Test

July 9, 2020

Viral infections caused by Flu A, Flu B, RSV and SARS-CoV-2 have similar clinical presentations, but the treatment options are different, the company noted. Read More

RapidAI’s Neuroimaging Analysis Device Cleared

July 9, 2020

The neuroimaging device helps stroke teams quickly assess patient eligibility for blood clot removal. Read More

Getinge Gets 510(k) Clearance for Mechanical Ventilator

July 9, 2020

The unit tracks patient ventilation over 72-hours, allowing healthcare providers to assess trends and determine the best follow-up care. Read More

Asuragen Gets CE Mark for Spinal Muscular Atrophy Assay

July 8, 2020

The polymerase chain reaction test delivers results in four hours. Read More

Medtronic Earns Clearances for Insertable Cardiac Monitor

July 8, 2020

Patients can send data from the device using a smartphone app or a home communicator device. Read More

Novartis’ Asthma Med, Inhaler and Sensor Cleared in Europe

July 8, 2020

The optional sensor can deliver data via a smartphone app. Read More

FDA OKs Abbott’s Implantable Heart Rhythm Devices

July 7, 2020

The two devices enable remote monitoring by using Bluetooth technology to communicate with smartphone apps, the company said. Read More

FDA Approves Cochlear’s Off-the-Ear Sound Processor

July 7, 2020

According to the company, the device is the world’s smallest off-the-ear cochlear implant. Read More

Becton Dickinson Earns EUA for Point-of-Care COVID-19 Test

July 7, 2020

The assay delivers test results within 15 minutes and does not require laboratory personnel, according to the company. Read More

Submissions and Approvals
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FDA Clears ivWatch’s Disposable Sensor for IV Infiltration Detection

Balt’s Flow Diverting Stent Receives CE Mark

Nonin Medical’s Portable Measurement Device Cleared

DiaSorin Earns CE Mark for Flu Assay to Run with COVID-19 Test

RapidAI’s Neuroimaging Analysis Device Cleared

Getinge Gets 510(k) Clearance for Mechanical Ventilator

Asuragen Gets CE Mark for Spinal Muscular Atrophy Assay

Medtronic Earns Clearances for Insertable Cardiac Monitor

Novartis’ Asthma Med, Inhaler and Sensor Cleared in Europe

FDA OKs Abbott’s Implantable Heart Rhythm Devices

FDA Approves Cochlear’s Off-the-Ear Sound Processor

Becton Dickinson Earns EUA for Point-of-Care COVID-19 Test

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The Revised ICH E8: A Guide to New Clinical Trial Requirements

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