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Owlet Announces FDA-Clearance of the First Prescription Pulse Oximetry Sock for Infants

Legacy MEDSearch

Food and Drug Administration (“FDA”) of BabySat , the first medical pulse-oximetry device featuring its advanced, wire-free sock design. The post Owlet Announces FDA-Clearance of the First Prescription Pulse Oximetry Sock for Infants appeared first on Legacy MedSearch | Medical Device Recruiters.

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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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HeartBeam Announces Acquisition of LIVMOR Assets

Legacy MEDSearch

Founded in 2016, LIVMOR developed the Halo+ Atrial Fibrillation (AF) Detection System, the world’s first FDA-cleared prescription wearable for continuous cardiac rhythm monitoring. HeartBeam AIMI and HeartBeam AIMIGo have not yet been cleared by the US Food and Drug Administration (FDA) for marketing in the USA or other geographies.

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Cresilon Receives First FDA Clearance For Human Use of Hemostatic Gel Technology

Legacy MEDSearch

Food and Drug Administration (“FDA”) for Cresilon Hemostatic Gel (“CHG ”). CHG is for prescription use only. The post Cresilon Receives First FDA Clearance For Human Use of Hemostatic Gel Technology appeared first on Legacy MedSearch | Medical Device Recruiters.

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First Light Field-Enabled Spine Surgery Navigation Platform, Proprio Paradigm™, Receives FDA Clearance

Legacy MEDSearch

Food and Drug Administration (FDA). Proprio’s goal is to dramatically improve clinical and economic outcomes by unlocking both the ability to capture advanced data and the potential of that data to inform more predictive and prescriptive intelligence in surgery.

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MedRhythms Announces FDA Listing of InTandem™ (MR-001) to Improve Walking and Ambulation in Adults with Chronic Stroke

Legacy MEDSearch

Food and Drug Administration (FDA). This important milestone enables the world’s first prescription music platform, and is a remarkable day for our company, for music, for healthcare, and most importantly for stroke survivors.”

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Diversity and inclusion in oncology clinical trials

Clarify Health

Food and Drug Administration (FDA) released guidance entitled, Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry. To advance equity in clinical research, the U.S. Clarify launched its real-world evidence on health disparities in 2021.