FDA

FDA Approves AI-powered OCT Health IT for Clinical Decision Support

August 3, 2021 - The Food and Drug Administration (FDA) has approved health IT vendor Abbott’s latest optical coherence tomography (OCT) imaging software that uses artificial intelligence (AI) to enhance clinical decision support for cardiologists. The imaging platform, powered by the company's new Ultreon Software, combines OCT with AI to provide...

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FDA Approves CLEW Medical’s Artificial Intelligence ICU Solution

by Samantha McGrail

CLEW Medical recently announced that FDA granted clearance and authorization for the use of its artificial intelligence-based ICU solution, used to predict hemodynamic instability in adult...

Robotic Surgery Tool Guides Neurosurgeons at UH Cleveland

by Samantha McGrail

Medtronic recently selected University of Hospitals (UH) Cleveland Medical Center as the second site for its Stealth Autoguide cranial robotic surgery guidance platform for neurosurgery. The system...

FDA Launches Center of Excellence to Advance Digital Health

by Samantha McGrail

FDA recently announced that it’s launching the Digital Health Center of Excellence within the Center for Devices and Radiological Health (CDHR) to advance digital health technology In the...

3D Digital Models Aid COVID-19 Diagnosis

by Samantha McGrail

LSU Health New Orleans radiologists and anatomists recently teamed up to demonstrate that 3D digital models may be a better tool to visually evaluate COVID-19. In a paper published in BMJ Case...

Roche Launches Digital Pathology Platform for Lung Cancer

by Samantha McGrail

Roche recently announced the CE-IVD launch of its automated digital pathology platform, uPath PD-L1 (SP263) for non-small cell lung cancer (NSCLC). uPath PD-L1 image analysis uses artificial...

FDA Clears Verily Study Watch for Irregular Pulse Monitoring

by Samantha McGrail

Verily Life Sciences was recently granted 510(K) clearance from the FDA for its Study Watch used with Irregular Pulse Monitoring, according to an official blog post from the Alphabet...

FDA to Examine Safety of Materials Used in Medical Devices

by Fred Donovan

The Food and Drug Administration (FDA) is holding a public advisory committee meeting next month with experts and the public to examine the safety of materials used in medical devices, the agency...

FDA Proposes Risk-Based Clinical Decision Support Software Rules

by Fred Donovan

The Food and Drug Administration (FDA) has released revised draft guidance on how it proposes to regulate clinical decision support software, after facing industry criticism of its 2017 draft...

Patient Death Prompts FDA Recall of Faulty Edwards Heart Valve Part

by Fred Donovan

The Food and Drug Administration (FDA) has issued a Class 1 recall (most serious) for a faulty component of the Edwards SAPIEN 3 transcatheter heart valve system, following reports of 17 injuries and...

FDA Funds Health IT Infrastructure for Rare Disease Research

by Fred Donovan

The FDA is providing funding to the Critical Path Institute (C-Path) and the Organization for Rare Disorders (NORD) for a centralized and standardized health IT infrastructure to support rare disease...

FDA Clears 2 Wearable Devices for Monitoring Patient Vital Signs

by Fred Donovan

The Food and Drug Administration (FDA) has approved two wearable devices designed to monitor patient’s vital signs. The FDA cleared an artificial intelligence-powered wearable device made by...

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