The FDA ends precertification (Pre-Cert) pilot program, saying new authority required to regulate software as a medical device (SaMD)

By SharpBrains | December 20, 2022

FDA acknowl­edges short­com­ings of Pre-Cert pilot in report (Reg­u­la­to­ry Focus): The US Food and Drug Admin­is­tra­tion (FDA) said it needs addi­tion­al Con­gres­sion­al author­i­ty to move for­ward with its dig­i­tal health pre­cer­ti­fi­ca­tion (Pre-Cert) pro­gram. While the idea has been wide­ly laud­ed by var­i­ous stake­hold­ers, at least one expert said he feels vin­di­cat­ed for warn­ing the agency early…

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Transcranial Direct Current Stimulation shows early promise to ameliorate depression, especially if combined with other therapies and dosage optimized

By SharpBrains | October 1, 2018

___ Tran­scra­nial Direct Cur­rent Stim­u­la­tion Promis­ing for Major Depres­sive Dis­or­der (Psy­chi­a­try Advi­sor): “Tran­scra­nial direct cur­rent stim­u­la­tion (tDCS) is an inves­tiga­tive modal­i­ty for major depres­sive dis­or­der (MDD) that has shown some promis­ing results. Though it has a while before it is approved by the US Food and Drug Admin­is­tra­tion, clin­i­cians and patients have been clam­or­ing for…

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