For the last few years, the phlebotomy world has been talking about Vitestro’s Aletta—the first CE-marked autonomous robotic phlebotomy device. (CE marking is the European equivalent of FDA approval, indicating the device meets EU safety and performance requirements for medical devices.) You’ve probably heard of this blood drawing robot. While it’s generating plenty of curiosity (and anxiety), let’s cut through the hype and look at what this technology actually does, what it can’t do, and what it means for working phlebotomists.

How It Works

Aletta uses AI-powered Doppler ultrasound and imaging technology to locate veins, then performs the entire blood draw autonomously—tourniquet application, skin prep, needle insertion, tube handling, and bandaging. The system uses ultrasound-guided 3D vein mapping combined with robotic needle insertion to standardize the procedure.

The device requires a phlebotomy order from a physician, just like manual draws—it doesn’t change the ordering process or clinical decision-making. It operates under the supervision of trained healthcare personnel, and patients complete the process with the machine while a phlebotomist or nurse oversees multiple devices simultaneously.

Which veins does it target? The published information doesn’t specify whether Aletta prioritizes the median cubital vein or will attempt any suitable antecubital vein it can visualize. Given the device’s emphasis on standardization and its 95% success rate, it’s likely programmed to select optimal veins—but the specific selection criteria haven’t been made public yet that I can find.

The Trial Results—and What They Actually Compared

Here’s where we need to be careful about what we’re reading. The Vitestro ADOPT (Autonomous Blood Drawing Optimization and Performance Testing) trial tested over 4,000 patients and reported impressive numbers:

• 95% first-stick success rate
• 0.6% hemolysis rate (well under the 2% benchmark)
• Median procedure time of 1 minute 49 seconds
• 98% patient acceptance
• 83% of patients rated pain as less than or comparable to manual draws

But here’s the problem: To claim Aletta is “comparable” to manual phlebotomy, Vitestro compares these results against three studies of manual venipuncture:

1. Howanitz et al. 1991 - Outpatient venipuncture (~97% success rate) - https://pubmed.ncbi.nlm.nih.gov/1929783/
2. Howanitz et al. 1994 - Inpatient venipuncture (93.2% success rate) - https://pubmed.ncbi.nlm.nih.gov/8204004/
3. Hefler et al. 2004 - Small pilot study comparing butterfly vs. straight needle

These studies are 30-35 years old. We’re comparing 2024 robotic technology against phlebotomy practices from when fax machines were cutting-edge office technology. The comparison tells us nothing about how Aletta performs against current phlebotomy standards, modern training protocols, or today’s experienced phlebotomists working with contemporary equipment. A LOT has changed in the phlebotomy world since then.

The methodology problem gets worse: While these study abstracts use the term “phlebotomist” throughout, they don’t specify who actually performed the draws at the participating institutions. Were these certified phlebotomists? Nurses? Lab techs? Medical assistants? A mix of all staff? Without access to the full text of these decades-old studies, we can’t determine the training level, experience, or credentials of the personnel who performed those 2+ million venipunctures.

Vitestro also states that manual success rates “can be as low as 80-89% depending on vein difficulty and the phlebotomist.” This may be true—but it’s not a fair comparison either. Of course success rates drop with difficult veins and inexperienced practitioners. The real question is: How does Aletta compare to skilled, experienced, certified phlebotomists working with modern equipment on similar patient populations? We don’t have that data.

Real-World Implementation: What U.S. Hospitals Are Seeing

In July 2025, CAP Today published an article profiling the first U.S. hospitals partnering with Vitestro for FDA trials: Northwestern Medicine, Mayo Clinic, and Baylor Scott & White Health. The piece provides some useful context—and reveals the primary motivation behind adoption.

• CAP article link: Too few phlebotomists–is Aletta the answer?

Dr. Gregory Retzinger, medical director of pathology clinical services at Northwestern Memorial Hospital, describes a particularly bad winter day when phlebotomists were calling off work and the outpatient diagnostic testing center was backed up. “We couldn’t collect samples from our outpatients,” he told CAP Today. “I said, ‘We can’t keep going through this. We have to have a solution.’” He reached out to Vitestro at exactly the right moment—they were already seeking U.S. clinical trial sites.

The honest motivation? “The biggest thing for us is we need personnel,” Dr. Retzinger said. “We want accuracy and precision and all of those things, but we also need to get the samples collected.”

Northwestern Memorial’s current first-stick success rate with their phlebotomy staff is about 92%, meaning Aletta’s 95% would represent a modest improvement. But the real value proposition isn’t superior performance—it’s addressing staffing shortages.

These hospitals aren’t just accepting Vitestro’s claims—they’re conducting their own validation studies. Mayo Clinic will lead a multicenter trial with two phases. The first phase will involve paired collections in healthy participants, comparing Aletta results directly to manual phlebotomy for what Dr. Brooke Katzman (Mayo’s co-director of the hospital clinical laboratory) calls “bread and butter tests”—the common tests most patients have ordered. They’ll evaluate specimen integrity parameters including first-stick success rate, hemolysis, and fill volume (particularly important for coagulation testing). They specifically chose some tests because they’re susceptible to preanalytical issues, like lactate dehydrogenase which is prone to hemolysis.

Phase two will involve single collections via Aletta for patients with clinical orders already placed, monitoring the same integrity parameters plus any adverse events. Northwestern will receive two devices for similar validation work. Vitestro plans to initiate the full U.S. multicenter study in early 2027, running for about five months, with hopes of submitting their FDA application in late 2025.

This is proper validation methodology—exactly what should happen when introducing new technology. We’ll finally get head-to-head comparisons between Aletta and current phlebotomy practice at major U.S. institutions, not just literature references from the 1990s.

Updated trial data presented at the 2025 Executive War College showed some improvements over earlier ADOPT results:

• Hemolysis rate: <0.1% (down from 0.6%)
• Median procedure time: 2.5 minutes (tourniquet to bandaging)
• Zero device-related adverse events
• For patients who self-reported as “difficult to draw”: 99% first-stick success (compared to 75-80% for manual phlebotomists with this population)

That last statistic deserves scrutiny. “Self-reported difficult to draw” is a subjective metric, and we don’t know how those patients would perform with experienced phlebotomists specifically, or what criteria patients used to classify themselves as difficult draws. In my experience, it seems like almost every other person thinks they are a tough stick.

The workforce angle: Dr. Retzinger envisions phlebotomists transitioning to oversee multiple devices. “There will be a more intellectual component to the phlebotomist in the future,” he said. “There will still be individuals involved in phlebotomy—just not the way they are now.”

To me, it sounds like it’s one way to frame “fewer phlebotomy positions needed.”

A notable gap: While several European hospitals have been using Aletta in routine practice since late 2024—including OLVG Lab, St. Antonius Hospital, Result Laboratorium, and Amsterdam UMC—there are no published independent evaluations or detailed operational reports from these sites (that I have been able to find). The European hospitals participated in the ADOPT trial and issued enthusiastic press releases about “very positive” patients and “enthusiastic” staff, but they haven’t published their own success rates, hemolysis rates, complication data, or operational metrics.

These sites have been involved with the technology since 2018 during development and trial, yet all the concrete performance data we have still comes directly from Vitestro’s own trial results, not from independent hospital validation studies. This stands in contrast to the U.S. approach, where Mayo Clinic and Northwestern are planning rigorous validation protocols before widespread adoption.

This matters because independent verification is a cornerstone of evidence-based practice. When hospitals adopt new technology and don’t publish their outcomes data, we lose the ability to assess real-world performance separate from manufacturer claims. The U.S. trials will hopefully fill this gap, but as of now, we’re still relying entirely on Vitestro’s self-reported data.

Known Limitations

Vitestro is being relatively transparent about the device’s current scope:

1. Patient Selection: Study participants had to be ≥16 years old with both arms available. Pediatric phlebotomy isn’t part of the current application. And as listed farther down, there are many things that can eliminate a person as a candidate for this machine (burns, mastectomy etc.).
2. Deployment Strategy: The company is initially targeting high-volume sites (100+ patients per day) and giving patients the choice between automated and manual draws. This suggests they’re positioning it for routine, outpatient blood draws rather than all clinical scenarios.
3. Difficult Draws: While 20% of study participants were categorized as “difficult to puncture,” we don’t have data on how the device performs with truly challenging venous access—oncology patients, IV drug users, severely obese patients, or patients with extensive scarring. The CEO acknowledged that “there is so much variation in arms, veins, patient behavior, etcetera, that this is not trivial.”
4. Supervision Required: The device operates under healthcare personnel supervision. It’s not replacing the human in the room—it’s changing what that human is doing.
5. Complications Management: One critical gap in the available information is how the device handles complications during or after the draw. What happens if a patient becomes vasovagal during the procedure? If they experience severe pain? If they need immediate intervention? What if the vein collapses? What happens if a bad tube doesn’t fill up correctly? The device requires trained personnel supervision, but the specific protocols for managing syncope, severe pain, allergic reactions, or other complications haven’t been detailed in public materials. This is a significant consideration because these situations require immediate human judgment and intervention—you can’t program a robot to catch a fainting patient or make split-second decisions about terminating a procedure. I’m curious about what the protocol is.

FDA Status

Aletta is NOT FDA-approved in the United States. It received CE marking in Europe in 2024 and is being deployed in European hospitals. Vitestro is conducting multi-center trials in the US (including with Northwestern Medicine) and “hoped to receive FDA de novo approval sometime in 2025”, but with it being mid December it looks like that won’t happen.

Will This Replace Phlebotomists?

Short answer: Not anytime soon, and probably not ever completely.

Longer answer: This technology is designed to handle routine, straightforward venipunctures in outpatient settings. Think standard morning blood draws at high-volume labs. It’s not designed for (and currently can’t handle):

• Pediatric draws
• Draws on those with certain disabilities, amputations, or impairments
• Patients requiring special positioning
• Hand or other alternative site draws
• Patients who need emotional support or have needle phobia
• Emergency situations requiring immediate intervention
• Managing complications like syncope mid-procedure
• Complex clinical situations requiring judgment calls
  • Arteriovenous fistula
  • Paralyzed limb
  • Mastectomy or lymph node removal
• Truly difficult venous access requiring skilled assessment
  • Infected skin
  • Healed burns
  • Extensive scarring
  • Hematoma’s in the AC
  • Tattoos

Vitestro’s own messaging positions Aletta as a tool to “allow phlebotomists and nurses to dedicate more time to patient care while addressing critical healthcare staffing shortages.” The reality is that if this technology succeeds, it will likely reshape the role rather than eliminate it—phlebotomists may supervise multiple devices, focus on difficult draws, and handle situations requiring human judgment.

I think it may get to the point where you find yourself managing these machines as part of your phlebotomy role someday, but again, the machine can’t do the tricky stuff, and that is where phlebotomists are critical, and irreplaceable. This machine can’t work around an arm that is stiff and crooked from old age. It can’t poke a newborn. It can’t work around a tattoo. You can.

The Real Questions

As this technology moves toward potential US approval, we need better data on:

• How does it perform compared to trained, experienced phlebotomists specifically—not just “manual venipuncture” in general?
• What percentage of patients won’t be suitable candidates for the device?
• Which specific veins can it access? Is it limited to median cubital, or can it work with basilic and cephalic veins? Does it account for the risk of accessing a basilic vein?
• What are the specific protocols for handling complications during automated draws?
• How will standard of care be defined when this technology becomes available?
• What happens when the machine fails to get blood—who takes over, and how does that affect overall workflow?
• What are the cost implications, and which facilities can actually afford this?

For Now…

Aletta represents genuine technological advancement in phlebotomy—the trial results are solid, and the standardization potential is real. But we’re nowhere near the point where robots will replace skilled phlebotomists. What we’re looking at is a tool that may eventually handle routine draws while trained phlebotomists focus on more complex cases.

If you’re a working phlebotomist, your job isn’t going anywhere. But it might be worth watching how this technology evolves and thinking about how to position yourself as the expert who handles what the machines can’t—the extra care and skill for those with disabilities, injuries, scars and more. You provide the warmth of human connection, and highly specialized training for the patients who need it. Nothing can replace that.

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Anyone have any inside info on these machines? I would love to hear about your experience. Also, please share your opinion on the future of blood draw robots.

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