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The second version, the Argus II, was designed to be smaller and easier to implant, and was co-invented by Mark Humayun of the USC Eye Institute, who had been involved in the clinical testing of the Argus I. [12] [11] The Argus II was first tested in Mexico in 2006, and then a 30-person clinical trial was conducted in 10 medical centers across ...
Under the Investigational Device Exemption (IDE) study by the FDA, the system was available to a limited number of U.S. patients at select hospitals and institutions. [7] The U.S. Food and Drug Administration (FDA) granted a breakthrough device designation in March 2021, [8] [9] expediting the review process, and later approved the device in ...
1 Medical technologies. 2 Pharmaceutical therapies. 3 References. ... MemoryGel Breast Implants [27] MemoryShape Breast Implants [28] [29] Artoura Breast Tissue ...
Globus Medical (NYSE: GMED) Q4 2024 Earnings Call ... We expect to gain FDA clearance of the headset in Q1. ... one of your large competitors announced the sale of their U.S. spinal implants ...
The FDA approved DBS for the suppression of tremor in the upper extremity in patients with essential tremor. Ventral intermediate nucleus of the thalamus (VIM) The approval was based on clinical trials showing significant tremor reduction with thalamic DBS in patients with essential tremor, demonstrating long-term efficacy and safety.
(Reuters) -The U.S. Food and Drug Administration on Wednesday classified a recall of Hologic's devices that are implanted in soft tissue such as breast tissue as "most serious", and urged doctors ...
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