Regulatory Approvals

Masimo wins FDA approval for Radius VSM monitor

Radius VSM helps clinicians monitor various physiological measurements. Masimo has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its patient-worn, continuous multi-parameter vital...

FDA Clears Sparrow’s Smartphone Stethoscope For Use by Medical Professionals

Sparrow BioAcoustics  announced it has received clearance from the U.S. Food and Drug Administration to market its software that allows smartphones to be used...

Ezra Receives 510(k) FDA Clearance For AI That Enhances MRI, Enabling Fast, Low-Cost Scans

Ezra, the healthcare AI startup transforming early cancer detection through full body MRI screening, announced that its newest proprietary Artificial Intelligence, Ezra Flash,...

THINK Surgical’s TMINI Miniature Robotic System developed with Sagentia Innovation gains FDA 510(k) clearance 

THINK Surgical, Inc. recently announced that its TMINI™ Miniature Robotic System has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). THINK Surgical...

Artiria Medical announces that its real-time deflectable guidewire has been granted the 510(k) clearance by the U.S. Food and Drug Administration (FDA).

Artiria Medical, a Swiss neurovascular MedTech company, announces that its real-time deflectable guidewire has been granted the 510(k) clearance by the U.S. Food and...

iHealthScreen receives FDA 510(k) for AI-enabled eye screening system

The company's iPredict System allows providers to detect age-related macular degeneration in the clinical setting. iHealthScreen, maker of AI-enabled software for retinal imaging, received FDA...

Meet the tiny, wireless sleep apnea diagnostic wearable headed for the US

U.K. medtech startup Acurable has gained FDA clearance for a novel wireless diagnostic device for remote detection of obstructive sleep apnea (OSA). A formal launch into...

Beta Bionics Announces FDA Clearance and Commercialization of the iLet Bionic Pancreas

First and only, automated insulin-delivery system that determines 100% of all insulin doses. - No carb counting*, no corrections, no calculating boluses. - Only...

Abbott Receives FDA Clearance for Assert-IQ™ Insertable Cardiac Monitor to Help Doctors Monitor People’s Heart Rhythms Long-Term

Abbott's Assert-IQ offers the world's longest battery life† for an insertable cardiac monitor (ICM) The latest addition to Abbott's portfolio of connected health devices, the...
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