According to Medtech Insight’s recently published report, US Markets for Neurostimulation Products, the frontier for neural stimulation is expanding rapidly, representing a $628 million market in 2006 that is forecast to grow by over 20% each year to produce sales approaching $2 billion in 2012. Topics discussed include implantable pulse generators, device reimbursement, and current and emerging applications for neurostimulation.
by Scott Huntley
As our brain, heart, intestines, and muscles function in an electrical manner, neurostimulation has emerged as an effective means of...
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Legal experts warn, however, that new Mexican procurement rules are discriminatory and could be challenged in the courts.
The US FDA has announced classifications for five device types, including four diagnostics as well as a hand cream to protect healthcare workers exposed to radiation. Two of the products are newborn screening tests.
It’s no secret that Marty Makary and Robert F. Kennedy Jr. have a different take on user fees, with Makary viewing them as a funding necessity and Kennedy as a corrupting influence. But will they find a way to strike a balance during the next MDUFA reauthorization talks so each can claim victory?
Flow Neuroscience's neuromodulation headset for the treatment of depression is approved and marketed in the EU. However, two years on, the company is still waiting for US FDA approval despite being assigned breakthrough device designation.
Overlapping clinical testing requirements and decision-making around significant changes to MDAI are among the tricky subjects that the new document explains.
FDA officials Michelle Tarver and Marty Makary discussed advancements in home healthcare during a podcast. They highlighted the importance of continuous glucose monitors, emphasized home healthcare's benefits for chronic diseases, and mentioned the agency's efforts to streamline device development.
The UK's regulatory agency is the first to join a new international network for oversight of AI in healthcare run by a non-profit organization, HealthAI, the global agency for responsible AI in health.
