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Enable Injections Receives First U.S. Food and Drug Administration (FDA)...
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®...
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FDA Grants ExThera Multiple Breakthrough Device Designations for its Seraph®...
ExThera Medical Corporation, a healthcare company developing and manufacturing extracorporeal pathogen technologies, announces that it has received multiple Breakthrough Device Designations from the...
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Stimdia Medical Inc. Initiates FDA Approved IDE Pivotal Trial to Investigate...
Stimdia Medical, a medical device company developing innovative technologies to improve respiratory care, today announced the initiation of its FDA approved pivotal trial to investigate the impact of...
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Cadence Announces the Acquisition of ARC Group Worldwide’s Florida Location
Cadence, Inc., a leading provider of design, development, and contract manufacturing services to the medical device, drug delivery, and diagnostics markets, announced today that it has acquired the...
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FDA Awards HistoSonics Clearance of its First-of-a-Kind Edison® Histotripsy...
HistoSonics®, (www.histosonics.com), the manufacturer of the Edison® System and novel histotripsy therapy platforms, announced today the marketing authorization of its “Breakthrough” platform via the...
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FDA clears Intelivation Technologies new Hammerdesis™ Interphalangeal Fusion...
Intelivation Technologies, an innovative medical device company with a cutting-edge orthopedic portfolio announced today that it has received clearance from the Food and Drug Administration for its...
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Brainomix and Nanoflex Robotics to Collaborate on an AI-Assisted Robotic...
Brainomix Ltd, an AI-powered medtech solutions company, and Nanoflex Robotics AG, a remote robotic surgical company based in Switzerland, have been awarded a grant under the “UK – Switzerland...
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Sparrow BioAcoustics Launches Software That Turns a Smartphone into a...
Sparrow BioAcoustics recently unveiled its StethophoneTM software, which transforms smartphones into medical-grade stethoscopes. This innovative tool enables users to capture, analyze, and share...
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FDA greenlights Boston Scientific’s Novel Drug-Coated Balloon for Coronary...
Boston Scientific’s AGENT Drug-Coated Balloon (DCB) has been granted approval by the U.S. Food and Drug Administration (FDA) for treating coronary in-stent restenosis (ISR) in patients with coronary...
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FDA Clears Dexcom’s First Over-the-Counter Continuous Glucose Monitor
On March 5, the U.S. Food and Drug Administration (FDA) announced the clearance of Dexcom’s device, marking it as the first continuous glucose monitor available over the counter. Following this...
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