How FOIA Requests Signaled Problems With a “Bionic Pancreas”
At a federal advisory panel meeting in 2018, a biomedical engineer named Ed Damiano stepped to the microphone – not just as a scientist.
“I’m also a father,” he told regulators, describing his son’s lifelong struggle with Type 1 diabetes and the years spent cycling through insulin pumps and glucose monitors. Damiano, a professor at Boston University and the chief executive of a promising start-up called Beta Bionics, was there to support a new generation of continuous glucose monitoring technology – part of what he called a growing ecosystem of tools that could transform diabetes care.
At the time, Damiano’s own company was developing what it described as a “bionic pancreas,” an automated insulin delivery system designed to reduce the burden on patients and minimize dangerous swings in blood sugar. The technology depended on the same class of sensors under discussion that day. Innovation, Damiano told the panel, required diversity, competition, and better tools for patients like his son.
“I cherish the power of choice and the immense value that a growing and ever more diverse medical technology ecosystem offers the T1D community,” Damiano testified. Innovation and competition would lead to a “newly invigorated industry” benefiting patients – and, implicitly, the venture capitalists and pharma companies that were betting millions of dollars on the success of Beta Bionics’ wearable automated insulin-delivery system connected to a smartphone app.
The Food and Drug Administration advisory committee voted unanimously that day to recommend approval of the continuous glucose monitoring system under review, clearing the way for a novel implantable sensor to reach the market. For Damiano, it was also part of a broader push: advancing a regulatory environment that would one day evaluate his own company’s device.
That moment – a founder advocating for innovation, grounded in personal experience – marked an early chapter in the rise of Beta Bionics. Years later, the company would bring its own system to market – the iLet bionic pancreas insulin pump – positioning it as a breakthrough in automated diabetes management. Cleared by the FDA in 2023 and later named one of Time magazine’s top inventions of that year, it was touted as a breakthrough in automated diabetes care.
“Accurate insulin, inspired by his diabetic son,” Time marveled. “Damiano spent 20 years creating the iLet, a credit-card-size, AI-powered smart device that links to a tube plugged into a patient’s body. Similar to existing options, it monitors glucose levels every five minutes. Unlike others on the market, it dispenses appropriate insulin microdoses when needed, fully automatically. The device was approved by the FDA in May, and recently gained Medicare and Medicaid approval.”
By then, Beta Bionics, which started out in 2015 with $5 million in seed money from Novo Nordisk and Eli Lilly, was on its way to eventually wrapping up $354 million in funding from big financial players eager to jump on the bandwagon.
An initial public offering followed in January 2025; the company raised another $204 million under the NASDAQ ticker BBNX. Damiano, the founder, was no longer the CEO as the company prepared to transition from development into commercialization. But he was still one of the biggest shareholders, with over 5 million shares valued at more than $85 million on the day the IPO closed.
Soon, the price of Beta Bionics shares would double, hitting nearly $34 a share. But almost one year to the day after the IPO, on January 9, 2026, Beta Bionics reported preliminary fourth-quarter results showing weaker-than-expected new patient starts, and Bank of America downgraded the stock from Buy to Neutral. The share price dropped by 35 percent.
The bright promise of a wearable “artificial pancreas” had a tarnished reality.
It would be another three weeks before more news hit. That was when the FDA, in a January 28 warning letter to Beta Bionics that has gone mostly unreported until now, branded the company’s iLet Dosing Decision Software and iLet Ace Pump – components of the bionic pancreas system – as “adulterated” products that jeopardized users. The warning letter read as a searing assessment of the company’s quality systems.
On its website, Beta Bionics says more than 10,000 people have started on the iLet system since the FDA approved it in 2023. But the agency’s warning letter cited hundreds of complaints from users and identified serious problems with the bionic pancreas system, including device malfunctions and dosing errors linked to dangerous blood-sugar swings. The agency said the company failed to adequately investigate those events or implement corrective actions despite mounting complaints and earlier concerns raised by FDA inspectors.
We asked Beta Bionics and its founder, Damiano, to respond to the FDA’s allegations. Damiano did not reply. A spokesman for Beta Bionics referred us to the company’s February 17 earnings call, where executives described the FDA’s warning letter as relating to quality systems and reporting processes, rather than the iLet system itself.
On that earnings call, the company’s CEO, Sean Saint, said: “From the limited public information available, these letters generally seem to have to do with issues concerning quality systems, indicating how challenging it can be to get these systems fully aligned with the FDA’s expectations without direct feedback from the agency. While these findings are serious, we also believe that they are straightforward, and that our remediation of the systemic issues found is well under way.”
Asked for a response, the FDA stated that it “generally does not discuss compliance matters except with the company involved. But as a general matter, warning letter recipients who fail to make adequate corrections are subject to enforcement actions, such as seizure, injunction, civil money penalties, or prosecution.”
The FDA’s warning letter recounted an alarming backstory that had quietly unfolded as BBNX shares ticked higher.
In June 2025, FDA inspectors arrived at Beta Bionics’ manufacturing facility in Irvine, California. By the time they left, they had identified a series of problems – including failures to adequately investigate device complaints and respond to reports of patient harm. The issues, later described in the FDA’s January 28 warning letter, included cases involving severe hypoglycemia and diabetic ketoacidosis.
Those findings did not immediately become public. Instead, they entered the FDA’s bureaucratic process for detecting and resolving deficiencies and potential violations. But long before the FDA warning letter, there was a pipeline of FOIA requests to the FDA that signaled problems ahead.
FOIA requests to the federal government can be an important early warning of bad publicity, litigation to come, or uncertainties to be hedged and gamed out. PoliScio Analytics’ competitive-intelligence database FOIAengine, which tracks FOIA requests in as close to real-time as their availability allows, shows that the earliest visible signal appeared on August 27, 2025. That was the day that Redica Systems, a firm that aggregates FDA inspection and compliance data, requested the Form 483 generated from the June inspection. (A Form 483, issued at the close of an inspection, documents observations of potential regulatory violations and often serves as the first written indication that inspectors have identified serious problems.)
Interest resurfaced in early November. On November 3, the Capitol Forum, an investigative outlet focused on regulatory risk, requested the same inspection records — the Form 483 or the more detailed Establishment Inspection Report tied to the June visit. A week later, a separate request from a FOIA service bureau asked for reports, tagging the company’s Irvine facility and federal establishment identifier. That appeared to be a proxy request to track the inspection and associated documents.
At that point, there still had been no FDA warning letter, no public disclosure, and no broad market reaction. The signal was confined to a small group of specialized actors working from the technical record of the inspection itself.
Only in late January 2026 did the FDA formally act, issuing the warning letter that laid out the agency’s concerns in detail. By then, the underlying issues had been known to regulators for months.
What followed was a rapid convergence of attention. On February 2, Truist Securities requested the June 2025 Form 483, the January 2026 warning letter, and related correspondence. “I am a research analyst covering diabetes companies and believe this is a matter of the public good and efficient securities markets,” the Truist requester, Ravi Misr, wrote.
The same day, Bridger Capital sought all inspection observations, warning letters, and company responses tied to Beta Bionics. Two days later, on February 4, the Capitol Forum made a request for the warning letter itself and the company’s response letters. Other requests soon followed.
The market reaction unfolded in parallel. Shares of Beta Bionics, which had traded at $34 earlier in the year, fell sharply in January and continued to decline as regulatory concerns compounded existing questions about growth and valuation.
In at least one instance, the public narrative itself became muddled. A Reuters market brief, crediting “AI-generated content,” traced back to a GlobeNewswire item attributed to Beta Bionics. But the underlying release was issued not by Beta Bionics, but by the plaintiffs’ law firm Block & Leviton (“we fight for investors”) announcing the firm’s securities investigation of Beta Bionics following the FDA warning letter.
The timeline underscores a recurring feature of FDA oversight: the gap between when problems are identified and when they are disclosed. In the Beta Bionics case, the underlying issues were visible to inspectors in June 2025 and were being pursued through FOIA requests by late summer. But they did not become public until the FDA warning letter was issued more than seven months later.
Beta Bionics shares have recently traded at around $9 a share, about half of their IPO value. Roughly 21 percent of the company’s public float is sold short – a high level that signals significant bearish positioning.
Recent SEC filings show the company’s largest shareholders now include Farallon Capital, RTW, Soleus Capital, and Point72, while earlier large holders such as Wellington Management have exited their positions.
During the February earnings call, Sant, the CEO, sounded undeterred as he sought to reassure investors that the FDA warning letter wouldn’t have an impact on the company or its future product development. “Now, for the fun stuff,” he said, pivoting to a discussion of the company’s next-generation automated insulin delivery device expected in 2027.
As if to underscore that, just two weeks ago – and two months after the FDA’s warning letter – Boston University featured its professor, Beta Bionics founder Damiano, and the bionic pancreas as one of the university’s “society-changing ideas” in a web post that compared Damiano’s device to BU Professor Alexander Graham Bell’s invention of the telephone.
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John A. Jenkins, co-creator of FOIAengine, is a Washington journalist and publisher whose work has appeared in The New York Times Magazine, GQ, and elsewhere. He is a four-time recipient of the American Bar Association’s Gavel Award Certificate of Merit for his legal reporting and analysis. His most recent book is The Partisan: The Life of William Rehnquist. His next book, Summer of ’71: Five Months That Changed America, about the fateful year before Watergate, will be out in June. Click here to watch the official book trailer. Jenkins founded Law Street Media in 2013. Prior to that, he was President of CQ Press, the textbook and reference publishing enterprise of Congressional Quarterly. FOIAengine is a product of PoliScio Analytics (PoliScio.com), a new venture specializing in U.S. political and governmental research, co-founded by Jenkins and Washington lawyer Randy Miller. Learn more about FOIAengine here. To review FOIA requests mentioned in this article, subscribe to FOIAengine.
Write to John A. Jenkins at JAJ@PoliScio.com.
