medical emergency product News
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BlueWillow Receives FDA Clearance to Begin Phase 1 Study of its Intranasal Anthrax Vaccine
BlueWillow Biologics®, a clinical-stage biopharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application for BW-1010, the company’s next-generation anthrax vaccine candidate. The Phase 1 clinical study is expected to begin enrollment this year and is being funded by the National Institute of Allergy and ...
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Vela Diagnostics Submitting Novel Coronavirus Diagnostic Test to FDA for Emergency Use Authorization (UPDATE)
Vela Diagnostics has developed the ViroKey SA201 SARS-CoV-2 RT-PCR Test, a new diagnostic test for the detection of COVID-19. Vela Diagnostics is currently in discussions with the U.S. Food and Drug Administration (FDA) for authorization of the test under the emergency use authorization (EUA). The EUA will allow the emergency use of FDA medical products in qualified labs, thereby facilitating ...
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Shockwave Medical and Genesis MedTech Obtain Regulatory Approval in China for Intravascular Lithotripsy
Shockwave Medical, Inc. (NASDAQ: SWAV), a pioneer in the development of Intravascular Lithotripsy (IVL) to treat severely calcified cardiovascular disease, and Genesis MedTech Group announced today that they have successfully obtained approval from China’s National Medical Products Administration (NMPA) to market and sell the Shockwave IVL System with the Shockwave C2 Coronary IVL Catheters ...
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