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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

Diagnostics & Healthcare News

Magnus Medical Announces First Participants Treated in Study Using SAINT Neuromodulation System for Major Depression

Magnus Medical, Inc., a medical device company and developer of brain stimulation technology for the treatment of neuropsychiatric disorders, today announced that the first participants have been treated in the Open Label Optimization (OLO) Clinical Trial evaluating the effectiveness of...

July 24, 2023

Diagnostics & Healthcare News

FDA Clears ReddyPort® Non-Invasive Ventilation Device

ReddyPort announced today that the US Food and Drug Administration (FDA) granted 510(k) premarket clearance for the ReddyPort elbow device used in non-invasive ventilation (NIV). “ReddyPort’s patented elbow is central to the eco-system we are building to help mitigate clinical...

July 18, 2023

Diagnostics & Healthcare News

Invictus Announces FDA Clearance of Ground-Breaking Neoasis® ANC Device

Invictus Medical announced today that the culmination of their De Novo application to the FDA for its Neoasis® incubator-based active noise control (ANC) device has resulted in a clearance-for-use declaration by the FDA. “With this clearance for use, Invictus has made a huge...

July 11, 2023

Diagnostics & Healthcare News

KORU Medical Systems, Inc. Announces 510(K) Submission for Freedom60® Infusion System With Hizentra® 50 Ml Prefilled Syringes

KORU Medical Systems, Inc. (NASDAQ: KRMD) (“KORU Medical” or the “Company”), a leading medical technology company focused on the development, manufacturing, and commercialization of innovative and easy-to-use specialty subcutaneous infusion solutions that improve quality of life for patients, today announced...

July 10, 2023

Diagnostics & Healthcare News

New FDA Clearance Makes Eyenuk the First Company with Multiple Cameras for Autonomous AI Detection of Diabetic Retinopathy

Eyenuk, a global artificial intelligence (AI) digital health company, and the leader in real-world applications for AI Eye Screening™ and AI Predictive Biomarkers™, has received U.S. Food and Drug Administration (FDA) clearance to use the Topcon NW400 retinal camera with...

June 22, 2023