The CEO of Flow Neuroscience has called out the US Food and Drug Administration (FDA) for market entry delays for clinically validated devices for treating depression.
The UK company’s CEO pointed out that in spite of these delays, the US market is instead ‘flooded’ with wellness products that lack clinical validation and make “vague” claims about their ability to ‘improve focus’ or relieve the symptoms of depression.
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Transcranial direct current stimulation (tDCS) devices such as the one developed by Flow, which gained a breakthrough device designation from the FDA in 2022, have been proposed as a new treatment in major depressive disorder (MDD).
In a recent international clinical trial of Flow’s device, the results of which were recently published in Nature Medicine, 57% of patients experienced remission from depressive symptoms and no severe side effects reported, while 92% of participants had a clinically significant response to the treatment.
Despite the breakthrough designation, Flow remains unavailable in the US.
“People can easily purchase wellness devices with no clinical evidence behind them, while science-backed companies are still waiting on regulatory approval,” said Flow Neuroscience CEO Erin Lee.
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By GlobalData“This kind of regulatory imbalance doesn’t just hold back innovation, but ultimately harms patients.”
Lee pointed out that the FDA system is “fundamentally inconsistent” and called its approach “two standards under one roof” given the FDA demands extensive US-based trials from devices that already meet international medical standards, yet at the same time, companies can “flood the wellness category with unverified claims and no clinical scrutiny”.
A recent whitepaper testifies to this gap. It found that 85-90% of medical devices in the US reach market via the 510(k) pathway, which doesn’t require clinical trials, while novel neuromodulation devices like tDCs are typically pushed into De Novo or Premarket Approval routes, requiring multi-year trials even if they have existing international approval.
Lee concluded: “In practice, what this means is that people in Sweden, the UK, or even Hong Kong can access a device like Flow, while Americans are left with expensive gadgets that claim to stimulate the vagus nerve or boost brainwaves, without any evidence.”
The FDA did not immediately respond to a request for comment.
