Mark Rubinshtein

Knobbe Martens

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Latest Posts › FDA Approval

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FDA Approves Neuralink to Begin Human Trials of Brain Implants

Neuralink, the biotechnology company founded by Elon Musk, has received approval from the U.S. Food and Drug Administration (FDA) to commence human trials of its implantable brain-computer interface device. Recruitment for...more

6/16/2023 / Clinical Trials , Elon Musk , FDA Approval , Food and Drug Administration (FDA) , Healthcare , Life Sciences , Manufacturers , Medical Devices , Pharmaceutical Industry

U.S. FDA Approves Monkeypox Treatment Formulation

(May 25, 2022) SIGA Technologies Inc., a New York-based pharmaceutical company, has received approval from the U.S. Food and Drug Administration (FDA) for an intravenous formulation of TPOXX (tecovirimat) for the treatment of...more

5/25/2022 / FDA Approval , Food and Drug Administration (FDA) , Healthcare , Infectious Diseases , Life Sciences , Pharmaceutical Industry , Pharmaceutical Patents , Prescription Drugs , Public Health , Public Health Emergency

FDA Approves First Generic Epinephrine Autoinjectors

The United States Food and Drug Administration recently announced approval for Teva Pharmaceuticals to market generic epinephrine autoinjectors. According to the press release, Teva’s autoinjectors are the first generic...more

10/2/2018 / FDA Approval , Food and Drug Administration (FDA) , Generic Drugs , Medical Devices , Teva Pharmaceuticals

FDA Approves Prickless Glucose Monitoring System

The U.S. Food and Drug Administration has announced approval of Abbott’s FreeStyle Libre flash glucose monitoring system for certain diabetes patients. The glucose monitoring tool will allow patients to monitor their glucose...more

1/29/2018 / Centers for Disease Control and Prevention (CDC) , FDA Approval , Medical Devices , Patents

Medtronic Receives Regulatory Approval for Surgical Navigation Device

According to Medtronic news release, the company recently received 510(k) clearance from the U.S. FDA and a CE mark from the E.U. for its StealthStation™ ENT surgical navigation system. The system will assist surgeons...more

9/22/2017 / 510(k) RTA , FDA Approval , Food and Drug Administration (FDA) , Medical Devices , Medtronic

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