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Transcutaneous electrical stimulation devices can be subdivided into three major categories: TENS, tVNS, and cranial electrotherapy stimulators, based on electrode placement on the body. TENS devices are used below the neck, tVNS devices are applied at the neck or ear, and CES devices are used above the neck. Although these devices are functionally similar, their FDA classifications differ significantly.

In a rare scheduling shift, the IEEE Engineering Medicine and Biology society shifted its biannual Neural Engineering (NER) conference from spring to late fall last month in San Diego. Sandwiched between the Neurotech Leaders Forum in San Francisco and buttressed immediately against Society for Neuroscience, the conference provided a meaningful bridge between the industry and commercialization focus of the former and the heavily pre-clinical and early research concentration of the latter.

As was the case in 2024, the year 2025 continued the progression of good news for the neurotechnology industry. And as was the case last year, this year was marked . While Boston Scientific’s $600 million purchase of Nalu was less than that firm’s $3.7 billion deal with Axonics in 2024, it pointed out the potential for startup PNS firms. As Jeremy Koff points out in his article on page 6 of this is…

For more than half a century, active implantable medical devices have been constrained energy into the body safely and efficiently. Whether used to power a device directly or recharge a deeply implanted battery, energy transfer physics have limited implant placement, longevity, size, and patient convenience. While electronics, sensing, materials, and algorithms have advanced rapidly, energy transfer from outside the body to within remains one of the defining limitations of implant design.

At the recent Society for Neuroscience meeting in San Diego, CA earlier this month, a panel of BCI researchers and clinicians participated in a press conference devoted to restoring touch, speech, and movement to paralyzed individuals. The press conference was moderated , director of the Neuro-X Institute at EPFL and founder of ONWARD Medical. Other panelists included Robert Gaunt, associate profes…

Neurotech Business Report The 25th annual Neurotech Leaders Forum, held in San Francisco, CA earlier this month, offered an opportunity for some of the industry’s seasoned pioneering figures to interact with upstart firms and promising investigators. The two-day event featured panel discussions on a number of key topics confronting the neurotech industry plus presentations from more than a dozen startup and emerging firms in the space.

Manufacturers of hypoglossal nerve stimulation systems for treating obstructive sleep apnea received some good news on the reimbursement front earlier this month. The U.S. Centers for Medicare & Medicaid Services finalized its CY2026 Hospital Outpatient Prospective Payment System and Ambulatory Surgery Center Rule. Within the final rule, CMS assigned CPT Code 64568, the code used for HGNS implants, to New Technology Ambulatory Payment Classification 1580.

Of all the sessions that took place during the 25th annual Neurotech Leaders Forum earlier this month, perhaps the one that stands out the most is the keynote address ’s former professor at Case Western Reserve University, J. Thomas Mortimer. In his talk, Mortimer reflected back on some of the experiences in his life where someone gave him the benefit of the doubt, and offered him an opportunity that would prove to be significant in his career.

Neurotech researchers and commercial firms have devised therapeutic approaches to treating a number of psychiatric disorders, such as major depression, OCD, and anxiety. More recently, some research teams have set their site on treating addiction, and one firm, Spark Biomedical, has obtained FDA clearance for its noninvasive Sparrow device to treat opioid use disorder. But a more challenging and ubiquitous form of addiction involves substances that are legal and commercially available, namely tobacco and alcohol.

This newsletter often covers the development of diagnostic devices that help identify disease severity and select suitable candidates for bioelectronic medicine therapies. A case in point is the use of cervical VNS for treating heart failure with reduced ejection fraction. Several clinical trials for HFrEF led , Boston Scientific, and LivaNova failed their primary endpoints, even though they were successful for a subset of patients.