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Aamir Ahmed Khan, PhD, principal electrical engineer at Paradromics, works on the transceiver that connects to the brain implants. Austin-based Paradromics is developing a brain-computer interface to help disabled and non-speaking patients communicate.
Julia Robinson | The Washington Post |
Good morning!
This week of July 4th started with some announcements in the neurotechnology space.
Brain implant startup Paradromics is preparing for its first human trial next year and announced the launch of its official patient registry on Monday.
Founded in 2015, Paradromics is developing a brain-computer interface (BCI) called Connexus Direct Data Interface. A BCI is a system that decodes brain signals and translates them into commands for external technologies.
Paradromics' system is initially designed to serve as an assistive communication device that can convert brain signals into text or synthetic speech, meaning patients with severe paralysis could eventually use it to regain their ability to communicate.
BCIs have been studied in academia for decades, and several other companies, including Elon Musk's Neuralink, are developing their own systems. The companies' designs and ambitions are all different, but the industry has taken off in recent years thanks to investments from prominent backers such as Musk, Microsoft co-founder Bill Gates and Amazon founder Jeff Bezos.
Gates and Bezos' investment firms have backed a BCI company called Synchron.
Paradromics' BCI is designed to be inserted directly into brain tissue, meaning patients who want the implant must undergo major surgery. While the procedure always carries risks, CEO Matt Angle told CNBC last year that the quality of neural signals Paradromics can measure allows patients to communicate faster and more naturally than would be possible with a less invasive BCI.
Paradromic scientists at work
Source: Paradromics
Before the company's technology becomes commercially available, it must undergo rigorous testing with the U.S. Food and Drug Administration, with the first human trial scheduled for 2025. Patients can express their interest in participating through Paradromics' new registry.
Paradromics also announced on Monday that the company has been included in the FDA's Total Product Life Cycle Advisory Program (TAP).
TAP is designed to speed up communication between the FDA and companies that have already received the agency's Breakthrough Device designation, which is given to medical devices that have the potential to provide improved treatment for debilitating or life-threatening conditions. Paradromics has received the Breakthrough Device designation twice, according to a press release.
The FDA can sometimes be slow to respond or difficult to reach because it often works with thousands of organizations simultaneously, so Paradromics' access to an open communication channel through TAP helps the company and the agency stay on the same page.
“We want to deliver the best possible device at the safest possible time and therefore appreciate access to the TAP program,” Angle said in the press release.
Feel free to send tips, suggestions, story ideas and data to Ashley at ashley.capoot@nbcuni.com.
Biden's appearance in the debate changes regulatory outlook
The first presidential debate between U.S. President Joe Biden and former U.S. President and Republican presidential candidate Donald Trump is projected onto a screen during a watch party hosted by the Michigan Conservative Coalition in Novi, Michigan, USA, June 27, 2024.
Emily Elconin | Reuters
Shares of Medicare Advantage insurers rose the morning after the first presidential debate as investors speculated that a Trump victory in November would lead to a more favorable regulatory outlook for the companies. New reimbursement and Star Bonus rules from the Centers for Medicare and Medicaid Services have weighed on Medicare Advantage plans' margins.
But CVS Health, Cigna And UnitedHealth Group Pharmacy benefit units have also come under pressure from a series of bipartisan bills introduced in both houses of Congress and from growing public criticism of their role in setting the drug prices patients pay. Regardless of who wins the White House, the pressure on pharmacy benefit units is unlikely to let up.
Please send tips, suggestions, story ideas and data to Bertha at bertha.coombs@nbcuni.com.
