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FDA Clears Dexcom’s First Over-the-Counter Continuous Glucose Monitor

Legacy MEDSearch

Food and Drug Administration (FDA) announced the clearance of Dexcom’s device, marking it as the first continuous glucose monitor available over the counter. Dexcom disclosed its plans to make Stelo available for purchase online without the need for a prescription, starting in summer 2024. On March 5, the U.S.

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FDA greenlights Boston Scientific’s Novel Drug-Coated Balloon for Coronary In-Stent Restenosis

Legacy MEDSearch

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 artery disease. ” The final results from AGENT IDE are expected to be presented at CRT 2024.

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FDA clears Intelivation Technologies new Hammerdesis™ Interphalangeal Fusion System

Legacy MEDSearch

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 Hammerdesis Interphalangeal Fusion System. This is a truly disruptive technology in a crowded area.

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Inspira™ Announces 510(k) FDA Submission of INSPIRA™ ART100 Towards Commercialization

Legacy MEDSearch

Food and Drug Administration (FDA) via the 510(k) pathway, with potential clearance expected during the first half of 2024. The Company’s vision is to transform external breathing assistance for over 20 million patients each year that require ventilation and oxygenation via external mechanical ventilation machinery.

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Exactech Announces FDA 510(k) Clearance for Advanced Activit-E™ Knee Replacement Polyethylene

Legacy MEDSearch

Food and Drug Administration for its new, advanced Activit-E polyethylene for the Truliant® knee replacement system. Global expansion will begin in 2024. The first products for Activit-E will launch in the beginning of Q3 2023 for select U.S.

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

Legacy MEDSearch

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 enhanced functionality will be made available commercially in 2024.

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BionicM Earns FDA Registration and Class II Exempt Device Listing for Bio Leg™; Its New Motor-Robotic Prosthetic Knee

Legacy MEDSearch

Food and Drug Administration (FDA) 510(k) exemption registration for Bio Leg ; its robotic prosthetic knee. This registration marks a significant milestone in the company’s commitment to deliver its robotic prosthetic knee to the USA market in 2024 with Japanese-proven technologies.

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