Neurostimulator Is First Device Marketed To Reduce Opioid Withdrawal Symptoms
FDA used its de novo pathway to clear Innovative Health Solution's NSS-2 Bridge – the first device for use in helping to reduce the symptoms of opioid withdrawal – as a class II device.
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Medtech Tools To Help Address Opioid Crisis Face Reimbursement Challenges
A wide variety of devices that could either serve as pain-relief substitutes for opioids, help manage opioid addictions or tackle distribution issues with the overly prescribed medications are facing reimbursement challenges at the US Centers for Medicare and Medicaid Services.
US Approvals Analysis: Molecular Dx Innovations Make Waves In November
Four novel molecular diagnostics, including two next-generation sequencing platforms, gained FDA approval in November, almost half of the nine novel-device approvals last month. The agency was also active with PMA supplement approvals and 510(k) clearances during the period.
Five Takeaways From Commissioner Gottlieb's Talk At The National Press Club
Among the topics US FDA Commissioner Gottlieb touched on were the agency's efforts to reduce clinical development burdens, improve information-sharing and comply with President Trump's two-for-one regulations order.