Digital Health FDA Cleared Patient Monitoring

BlueStar’s eighth FDA clearance adds long-acting basal insulin support for Type 2 patients

Released on June 3, 2020

WellDoc’s BlueStar chronic disease-management tool has picked up another 510(k) FDA clearance that will allow it to support adult Type 2 […]

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FDA Cleared Orthopedic Spine

Meditech Spine receives FDA clearance for CURE Opel lumbar plate system

Released on June 3, 2020

Meditech Spine has received US Food and Drug Administration (FDA) 510(k) clearance to market the CURE Opel-L (S) system, a new […]

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FDA Cleared MedTech Women's Health

Gynesonics lands FDA clearance for fibroid-removal system

Released on May 29, 2020

Gynesonics announced that it received FDA 510(k) clearance for its next-generation Sonata System 2.1 for transcervical fibroid ablation (TFA). Redwood City, Calif.-based […]

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FDA Cleared Orthopedic Spine

Nexxt Spine receives US FDA 510(k) clearance for ALIF and lateral systems

Released on May 29, 2020

Nexxt Spine has announced US Food and Drug Administration (FDA) 510(k) clearance of two lumbar based systems, for anterior lumbar interbody […]

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FDA Cleared Imaging Radiology

FDA clears United Imaging’s MRI

Released on May 27, 2020

Medical imaging and radiotherapy outfit United Imaging announced today that it received FDA clearance for its UMR Omega MRI scanner. Shanghai-based United Imaging, […]

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Digital Health FDA Cleared Respiratory

FDA clears Propeller Health sensor for use with AstraZeneca’s Symbicort inhaler

Released on May 26, 2020

Digital respiratory health company Propeller Health has received 510(k) clearance for a sensor and app intended for use with AstraZeneca’s Symbicort […]

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FDA Cleared Respiratory Wearables

Philips receives FDA clearance for patch that monitors breathing

Released on May 26, 2020

Designed long before the Covid-19 pandemic, Philips received FDA clearance for a wearable sensor that can track respiratory rate. The disposable […]

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Diagnostics FDA Cleared Respiratory

4DMedical’s Lung Imaging Technology Receives FDA Clearance as COVID-19 Intensifies Global Focus on Respiratory Health

Released on May 25, 2020

WOODLAND HILLS, Calif., May 25, 2020 /PRNewswire/ — 4DMedical, an Australian medical technology company specializing in medical imaging innovation software, announced today it has […]

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Cardiology Diagnostics FDA Cleared

Philips Ultrasounds Cleared in U.S. to Manage COVID Complications

Released on May 18, 2020

The FDA has granted Philips 510(k) clearance for its ultrasound systems to be used to address lung and cardiac complications that […]

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FDA Cleared Orthopedic Spine

US FDA approval granted for two Camber Spine devices

Released on May 11, 2020

Camber Spine has announced US Food and Drug Administration (FDA) clearance and the nationwide launch for two novel anterior cervical devices, […]

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FDA Cleared Orthopedic Spine

NuVasive expands Advanced Materials Science implant portfolio

Released on May 6, 2020

NuVasive has announced the expansion of its Advanced Materials Science (AMS) implant portfolio with the commercial launch of the Modulus XLIF […]

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FDA Cleared MedTech

MOLEKULE Unveils Air Pro Rx Medical Air Filter to Protect Hospitals During COVID Pandemic

Released on April 28, 2020

Molekule, a company based in San Francisco, is releasing its brand new Air Pro Rx air purifier. The system has been […]

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