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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 addition of the FDA-cleared BabySat device expands on Owlet’s existing portfolio of consumer products designed to bring peace of mind to caregivers. BabySat will be available in the U.S.

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FDA rejects Spectrum’s lung cancer drug poziotinib

pharmaphorum

The FDA has issued a complete response letter (CRL) to Spectrum Pharma for poziotinib, its pan HER2 inhibitor for a form of lung cancer, according to South Korea’s Hanmi Pharma, which originally developed the drug. The post FDA rejects Spectrum’s lung cancer drug poziotinib appeared first on.

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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. Are you hiring?

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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 ”). This marks Cresilon’s first FDA clearance for human use, validating its revolutionary hemostatic gel technology and the company’s global mission to transform wound care. CHG is for prescription use only.

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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.” ” InTandem is anticipated to be available soon in select market segments.

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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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HeartBeam Announces Acquisition of LIVMOR Assets

Legacy MEDSearch

The acquisition extends HeartBeam’s reach in remote monitoring and detection with full ownership of an existing cutting-edge FDA-cleared product. 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.