In 1998, a chemical engineer named Mark Prausnitz published a short paper in the Journal of Pharmaceutical Sciences with a plain title: “Microfabricated microneedles: A novel approach to transdermal drug delivery.” It was the first real demonstration that you could borrow the tools of the semiconductor industry, etch an array of needles too small to feel, and use them to push a drug painlessly through the outer skin. Vaccines, insulin, proteins. The whole point was to get something into the body without the dread of a hypodermic.

Twenty-eight years later, the single largest holder of US microneedle patents runs the needle backwards. It puts nothing in. It reads what is already there.

That company is Biolinq, a quiet firm in San Diego, and in the count of US utility patents that mention microneedles, it now sits at the top of the field. Since the start of 2022, Biolinq has been granted 15 microneedle utility patents, more than any other single organization, out of roughly 300 such grants across everyone. Second place, with eight, is Georgia Tech Research Corporation, the institution where Prausnitz built the field. The lab that invented the microneedle to deliver drugs has been passed by a company that inverted it to sense them.

Look down the rest of the leaderboard and the inversion gets sharper. The other names clustered near the top are LTS Lohmann, Kindeva Drug Delivery, Sorrento Therapeutics, Cosmed, Fujifilm, North Carolina State, the University of Pittsburgh. Almost without exception, they are working the original problem: patches that deliver a vaccine, a hormone, a small molecule through the skin. Biolinq is the outlier in its own category. Mentally strip the word “microneedle” from every filing and the descriptions still split cleanly into two piles, and Biolinq is alone in the second one.

What the claims actually describe

Read the patents and the machine comes into focus. One 2024 grant covers the “heterogeneous integration of silicon-fabricated solid microneedle sensors and CMOS circuitry” — in plain terms, growing the needles and the readout electronics on the same chip. Another describes a microneedle with a tapered tip, an insulated apex, and an electrode sitting just below that apex, with each needle “individually addressable” so the device can poll them one at a time. A third layers on the chemistry: a biorecognition film, a diffusion-limiting membrane, an interferent-blocking agent, all electrodeposited onto the electrode to turn glucose into a clean current.

The needles are made of silicon, etched the way chips are etched. Biolinq’s engineers like to point out that at this scale silicon is harder than titanium or steel, which is why the needles survive being pressed into skin. Each sensing chip is two millimeters on a side and carries seven independent microneedles; the company says it prints more than 2,000 of these microsensor components onto a single 200-millimeter wafer. That is a semiconductor foundry economics curve pointed at a medical sensor, and it is the reason a startup can talk about scale the way a fab does.

The redundancy is not decoration. One granted patent is entirely about fault detection: model the electrode array as an electrical network, watch the voltage at a counter electrode, and use it to spot which needles have drifted or failed mid-wear. A single filament that fouls is a dead sensor. Seven needles voting is a sensor that degrades gracefully. That is the difference between a lab demo and something the FDA will let you sell.

Why the depth matters

Here is the part an R&D director should care about. The two companies that own continuous glucose monitoring today, Abbott and Dexcom, both sense the same way: a thin metal filament inserted several millimeters down into the fat layer beneath the skin. Between them, plus Medtronic, they controlled roughly 97 percent of US CGM shipments in 2025 in a market worth something like $13.6 billion and climbing toward $29 billion by the end of the decade. And in all of that, the filament is sacred. In our patent data, Dexcom holds zero microneedle grants. Abbott holds one.

Biolinq’s needles stop in the dermis, the middle layer of skin, which the company describes as up to 20 times shallower than the incumbent filaments. Shallower is the whole pitch: less to feel, less foreign body, a sensor that reads interstitial fluid without committing to the subcutaneous plunge. The incumbents’ entire patent moat is built around the deep filament. Biolinq spent a decade patenting the case for not going deep. Those are not competing improvements on the same idea. They are two different bets about where in the skin glucose is worth reading, and only one of the two camps has meaningful IP on the shallow answer.

In September 2025, that bet cleared regulatory reality. The FDA granted Biolinq a de novo authorization for a device it calls Shine, the first needle-free glucose biosensor cleared in the United States. It is a small patch for the forearm with a colored light built into it, blue when glucose is in range, yellow when it climbs, no phone required to read the basic signal. And crucially, it was cleared for people with type 2 diabetes who do not use insulin, roughly 25 million Americans, the exact cohort Abbott and Dexcom are now racing to reach with their own over-the-counter sensors. Three companies, one customer, three different pieces of hardware pressed against the same forearm.

The people, and the door they walked through

The backstory explains the inversion. Biolinq was founded in 2012 by Joshua Windmiller and Jared Tangney, who met as PhD students in the NanoBio-Electronics Lab at UC San Diego, run by Joseph Wang. Wang is one of the central figures in wearable electrochemical sensing, the person behind temporary-tattoo sensors and sweat-reading electrodes, and the early Biolinq idea reportedly grew out of a lab project to detect battlefield injuries by chemistry rather than sight. Windmiller and Tangney did not come from the drug-delivery world at all. They came from the sensing world, and they picked up the microneedle as a piece of hardware that happened to be perfect for reaching the fluid they wanted to read.

That is the adjacent-possible move in its cleanest form. The microneedle already existed. The enzyme electrode that turns glucose into current has existed since Leland Clark’s work in the early 1960s. Silicon wafer fabrication existed. Nobody in the drug-delivery field needed to combine them, because delivery does not care about reading a signal back out. It took people trained to think of the skin as something to listen to, not dose, to see that the vaccine patch and the glucose meter were one small recombination apart.

Biolinq raised a $100 million Series C in April 2025, led by Alpha Wave Ventures, to push Shine into the US market. The first-generation patch lasts about five days on a battery. The more interesting line in the interviews is that the same electrode chemistry can be tuned to read lactate and ketones, which turns a glucose monitor into what the company calls a metabolic panel on a single chip. If that holds, the thing Prausnitz built to deliver a flu vaccine becomes the substrate for a general-purpose blood chemistry lab you wear on your arm.

The incumbents have the market and the filament. Biolinq spent ten years quietly patenting the case that the future of reading the body is a tool everyone else was using to feed it.

Method note. Patent counts come from a corpus of 9.3 million US utility grants sourced from USPTO bulk grant XML, searched by full text for microneedle references and grouped by assignee; each company’s total combines variant spellings of its name, and design patents are excluded so the counts reflect functional inventions. The window for the leaderboard is January 2022 through the most recent grants in the corpus (mid-June 2026); Biolinq’s most recent grant in the set issued in late July 2025. FDA clearance, funding, founder history, and device specifications were confirmed through IEEE Spectrum, MedTech Dive, Drug Delivery Business News, BusinessWire, and UC San Diego reporting. CGM market shares and the size of the non-insulin type 2 population are drawn from published 2025 market analyses and company statements; they are third-party estimates, not our data. A patent lead is a measure of who has filed, not who will win the market.