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Medical Devices

Vapotherm’s HVT 2.0 System Overcomes Regulatory Hurdles for Entry into South America’s Largest Health Care Market | BioSpace

EXETER, N.H., Feb. 29, 2024 /PRNewswire/ -- Vapotherm, Inc. (OTCQX: VAPO), ("Vapotherm" or the "Company"), a global medical technology company specializing in the development...

FDA Draft Guidance on Metallic or Calcium Phosphate Coatings: Non-Clinical Bench Testing | United States

The article describes in detail the approach to be applied with respect to non-clinical bench testing medical devices should undergo in order to collect...

FDA Draft Guidance on Metallic or Calcium Phosphate Coatings: Specific Aspects | United States

The article addresses specific aspects to be taken into consideration concerning premarket submissions for orthopedic devices with metallic or calcium phosphate coating, including the...

Two Review Reports for Imported Devices Issued in January

NMPA published twelve review reports in January 2024 for innovation devices. Among them are two imported devices. These published review reports serve as important references...

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