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Economists often describe a product’s life cycle as a transition through four stages: introduction, growth, maturity, and decline. When a product approaches the decline stage, offshoring of manufacturing has been a common approach for cutting labor costs. Let’s examine whether the active implantable device industry is nearing its decline. We’ll start our evaluation with cardiac rhythm management de…

Radiotracers, pivotal in advancing neurotechnology and bioelectronic medicine, allow for the noninvasive visualization of biochemical processes, particularly in the brain. These compounds, tagged with radioactive elements, are used in PET imaging techniques to provide detailed views of cellular and molecular biological activities. Their role is vital for understanding and treating complex neurological and physiological conditions.

SetPoint Medical, the Valencia, CA manufacturer of bioelectronic medicine systems, is rightfully considered the pioneer in the field. Since the company’s founding in 2007, it gradually grew to employ more than 80 people and raise more than $300 million in capital to date. The initial market for SetPoint’s VNS therapy is rheumatoid arthritis, with the PMA approval expected next year. With its pivota…

The issue of neurotech privacy is one that has attracted considerable attention from the general public recently. Long-time readers of this publication will recall that we have advocated for protecting users’ neural data from the outset in this space. The issue has taken on more immediacy this month, when the state of Colorado became the first to pass legislation that specifically protects neural data gathered from consumer neurotech devices.

Bioelectronic medicine vendors and researchers pursuing novel applications of sensing and stimulation technology have much to gain the cardiac device industry. In the future, we expect advances in cardiac devices to be intertwined with advances in neuromodulation. One area that is ripe for development involves the integration of implanted devices with human tissue. Neural engineers developing next-…

Manufacturers of implanted and noninvasive peripheral nerve stimulation systems see tremendous opportunity in the years ahead for treating a wide variety of neurological conditions that are not well served pharmaceutical therapies. But the wide-open market opportunity for PNS is tempered obtaining reimbursement for their products. Perhaps the greatest obstacle confronting PNS vendors is the relatively low levels of payment offered and Medicaid Services, which often sets the standard for private payers.

The bioelectronic medicine market for treating sleep disorders using hypoglossal nerve stimulation is rapidly becoming more competitive as new vendors emerge and existing players report progress. While Inspire Medical currently has the U.S. market to itself, Nyxoah has begun to compete in Europe and expects to gain FDA approval soon. Earlier this month, Nyxoah announced that its DREAM pivotal study in the U.S.

Executives and entrepreneurs from several neurotechnology firms participated in the 2024 LSI Emerging Medtech Conference in Dana Point earlier this month. The conference featured numerous sessions with medtech investors and strategics offering insights on commercialization issues. Among the neuromodulation firms making presentations at the event were Bionic Vision Technologies, BackStop Neural, Neu…

Over the last few years, media attention to advances in brain-computer interface technology has spiked considerably, in large part because of announcements firm, Neuralink. Make no mistake, Neuralink’s progress has been noteworthy, particularly reports from the company’s first patient, who was able to move a computer cursor and play computer games using the company’s implanted device. But putting a…

Future advances in implantable neurotechnology devices will depend heavily on developments in materials science. In particular, soft, thin, flexible materials that conform to neural tissue and conduct electricity are highly desirable for brain implants. Researchers at a number of institutions have recently reported progress with two such materials: EGNITE and PEDOT: PSS. A study published in Nature…