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Diagnostics & Healthcare News
U.S. FDA Grants Paige Breakthrough Device Designation for Cancer Detection in Breast Lymph Nodes
Paige, a global leader in end-to-end digital pathology solutions and clinical AI applications that assist in diagnosing cancer, announced today that the U.S Food and Drug Administration (FDA) has granted Breakthrough Device Designation for Paige Lymph Node1, an AI application...
November 1, 2023
Diagnostics & Healthcare News
New Study Demonstrates Consistent Positive Long-Term Adherence and Efficacy of Nerivio® for Treatment of Migraine
Theranica, a neuromodulation therapeutics company, announced the publication of a comprehensive clinical study in Advances in Therapy examining the long-term utilization, clinical efficacy, and safety of Nerivio®, a Remote Electrical Neuromodulation (REN) device for the treatment of migraine. The study included 409...
October 25, 2023
Diagnostics & Healthcare News
FloBio Receives FDA’s Breakthrough Device Designation for Bleeding Risk Diagnostic Test
 FloBio, a medical diagnostics company, announced today that the U.S. Food and Drug Administration has granted Breakthrough Device Designation for its rapid bleeding risk diagnostic test. The FDA recognizes that the device will provide for more effective treatment or diagnosis...
October 17, 2023
Diagnostics & Healthcare News
Enable Injections Receives First U.S. Food and Drug Administration (FDA) Approval
Enable Injections, Inc. (“Enable”) today announced that the U.S. Food and Drug Administration (FDA) has approved the EMPAVELI Injector (enFuse®) for the subcutaneous delivery of EMPAVELI® (pegcetacoplan), which is commercialized in the United States by Apellis Pharmaceuticals, Inc. for adults with paroxysmal nocturnal hemoglobinuria (PNH). The...
October 2, 2023
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
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