News

The U.S. Centers for Medicare & Medicaid Services recently issued draft rules for hospital price transparency, which stand to exert a profound effect on manufacturers of implanted bioelectronic medicine systems. The new rules state that beginning January 1, 2024, CMS will start enforcing the requirement that all U.S.-based hospitals and ambulatory surgical centers publicly list their standard patient charges in a machine-readable file.

Medical device industry professionals traveled to Anaheim, CA for the 2023 MedTech Conference, produced earlier this month. Neurotechnology firms played an active role in the meeting. One of the unique attributes of this conference was a series of “reverse pitches” in which large strategic medtech firms informed startups of the advantages of partnering with them. Chris Cleary, senior vice president for business development at Medtronic, was one such presenter.

Neurotechnology researchers and manufacturers are well aware that clinical trials and the collection of evidence supporting a new therapy are important elements of the commercialization process. No one in this field would argue that advanced medical products, particularly implantable devices with sophisticated electronic components should be marketed without some degree of testing to ensure that the products are safe and do what they’re supposed to do.

For seasoned professionals working with implanted neurotechnologies, the challenge has always been multi-fold: how do you achieve high resolution in neural recordings, minimize scarring, and maintain the structural integrity of brain tissue? One new development at the University of Utah is the biohybrid transition microelectrode array (TMEA). The developers of these biohybrid electrodes were motivated neural implants and the desire to ensure that an implant’s survival matches the patient’s lifespan.

Neurotech Reports, the publisher of this newsletter, released a newly revised market research report detailing the implanted pain neuromodulation device industry. The report, titled The Market for Implanted Pain Neuromodulation Systems: 2023-2028, estimates that the total worldwide market for implanted pain neuromodulation systems will grow from $2.66 billion in 2023 to $5.88 billion in 2028. The new report breaks down the market by U.S.

One of the most significant advances in the implanted neuromodulation device space has been the integration of digital devices such as patient controllers and handheld tablets. Of all the competitors in this market, Abbott has been at the forefront of this trend. The company’s NeuroSphere myPath digital health offering, which works with both Apple iOS and Android devices, raised the bar for connecting SCS and DRG patients with their clinicians.

The quest to restore sight to those blinded one of the most technologically challenging applications of neuromodulation over the past few decades. Retinal stimulation devices, developed to assist those affected degeneration, translate visual data into electrical impulses. These signals, either initiated from mounted cameras or directly from microchips in the retina, are conveyed to the brain, helping patients discern patterns of light and darkness, which with training, translates into meaningful imagery.

Earlier this year, the number of patients implanted with sacral nerve stimulation devices reached 400,000, including more than 380,000 patients implanted with Medtronic’s InterStim system and more than 20,000 implanted with Axonics’ SNM devices. Reaching this milestone provides us with an occasion to reflect on safety of SNS devices. As analyzed in a recent review, since 2016, there has been a stea…

In the time that has transpired since the medical device industry mourned the loss of the Medicare Coverage of Innovative Technology program, more than a handful of neurotech companies, including many startup firms, have felt the pain. After being promised they would qualify for at least four years of CMS coverage once they got FDA approval, recipients of breakthrough device designation found out that was just a cruel ruse when CMS pulled the plug on the MCIT program.

One of the earliest researchers to explore therapeutic applications of implanted brain-computer interfaces, Phil Kennedy, founder of Neural Signals, Inc., announced that his firm has entered into a joint-venture relationship to market a BCI system. The new firm, called Neural Logistics LLC, is joint venture between Neural Signals and a public firm called DarkPulse, Inc. Neural Logistics is seeking…