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Diagnostics & Healthcare News

Beacon Biosignals Receives FDA Clearance for AI-Assisted Sleep Monitoring Device Dreem 3S

Beacon Biosignals is thrilled to announce the milestone achievement of FDA 510(k) Clearance for the Dreem 3S, an advanced wearable headband with integrated machine learning algorithms to capture electroencephalogram (EEG) data from the brain to monitor sleep architecture and aid in the...

September 14, 2023

Diagnostics & Healthcare News

alveoair® has received U.S. FDA clearance, marking a significant advancement in respiratory care

alveofit® (Roundworks Technologies Private Limited) is thrilled to announce that its groundbreaking product, alveoair® spirometer, has earned U.S. FDA clearance for distribution in the United States. Specializing in digital therapeutics for respiratory care, the company is committed to delivering affordable and...

September 7, 2023

Diagnostics & Healthcare News

Abbott to Acquire Bigfoot Biomedical, Furthering Efforts to Develop Personalized, Connected Solutions for People with Diabetes

Abbott (NYSE: ABT) and Bigfoot Biomedical today announced a definitive agreement for Abbott to acquire Bigfoot, a leader in developing smart insulin management systems for people with diabetes. The transaction is subject to customary closing conditions and is expected to close in the third quarter...

September 6, 2023

Diagnostics & Healthcare News

Paragonix Technologies Receives FDA Clearance for BAROguard™ Donor Lung Preservation System

Paragonix Technologies, a leading organ transplant company, received US Food and Drug Administration (“FDA”) clearance for its next-generation donor lung preservation system, BAROguard™. The BAROguard™ System combines Paragonix’s existing advanced hypothermic preservation technology with automated continuous and active airway pressure...

August 25, 2023

Diagnostics & Healthcare News

InBody Hits Milestone: 100 Million Tests Recorded Globally on Their LookinBody Web Platform

Highlighting a growing interest in body composition data, InBody is celebrating a long-anticipated milestone: 100 million tests taken globally on their body composition analyzers as of Friday, Aug. 4. “We’ve come a long way since InBody’s founding in 1996,” said...

August 18, 2023

Diagnostics & Healthcare News

Welldoc Receives 10th 510(k) Clearance from FDA for Award-Winning Diabetes Platform BlueStar®

Welldoc®, a digital health leader revolutionizing chronic care, today announced the receipt of its 10th 510(k) clearance from the Food and Drug Administration (FDA) for its award-winning diabetes digital health solution, BlueStar®. This clearance reinforces Welldoc’s position as a leader...

August 17, 2023

Diagnostics & Healthcare News

Ceribell Receives FDA 510(k) Clearance and CMS NTAP Reimbursement for New ClarityPro™ Software with Electrographic Status Epilepticus Diagnostic Indication

Ceribell, Inc.® announced that its new software ClarityPro has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the indication of diagnosing Electrographic Status Epilepticus (ESE). The clearance follows prior receipt of Breakthrough Device Designation from FDA. Subsequent...

August 16, 2023

Diagnostics & Healthcare News

Grand Piano Passion Identifies Best Hearing Aid Technology for Music

Grand Piano Passion™, the leading resource for musicians and music lovers with hearing loss, reviews hearing aids and alternative devices for music in their new technology guide. Access the Guide: Hearing Aids and Music Technology. Half of classical musicians and one-third...

August 8, 2023

Diagnostics & Healthcare News

Quanta™ Receives FDA 510(k) Clearance for Expanded Indication of Continuous Renal Replacement Therapies

Quanta Dialysis Technologies®, a medical technology company committed to making kidney care more accessible, today announced that it received U.S. Food and Drug Administration (FDA) 510(k) clearance for an expanded indication of the Quanta Dialysis System, a compact and easy-to-use...

August 3, 2023