Median Technologies submits U.S. application for 510(k) clearance of eyonis ® LCS
Median Technologies (FR0011049824, ALMDT, PEA-PME scheme eligible, 'Median' or the 'Company'), manufacturer of eyonis ®, a suite of artificial intelligence (AI) powered Software as a Medical Device (SaMD) for early cancer diagnosis, and a globally leading provider of AI-based image analyses and central imaging services for oncology drug developers, today announced it has filed an application to the U.S. Food and Drug Administration (FDA) for 510(k) clearance of eyonis ® LCS, its AI/ML tech-based SaMD for computer aided detection and diagnosis (CADe/CADx) in lung cancer screening.
The submission is based on positive data from the two pivotal studies of eyonis ® LCS, REALITY and RELIVE, both of which met their primary endpoints. This data demonstrated that eyonis ® LCS provides robust diagnostic performance for early detection and characterization of lung nodules in high-risk lung cancer populations, with significant potential to impact patients' clinical outcomes. Additionally, Median's eyonis ® LCS SaMD confirmed safety and efficacy in RELIVE, the second and last pivotal study.
' eyonis ® LCS' FDA filing is a major milestone for Median and a testament to our R&D and clinical programs' strength, ' said Fredrik Brag, CEO and Founder of Median Technologies. 'RELIVE and REALITY pivotal studies met their primary endpoints and confirmed the device's safety and efficacy. This shows that eyonis ® LCS has the potential to be a game-changer in lung cancer screening. By providing early detection and characterization at scale, eyonis ® LCS can significantly improve high-risk patient outcomes. Based on average observed review regulatory timeframes, we would expect an eyonis ® LCS' clearance in the U.S. in Q3 this year.'
Results from REALITY released in August 2024, showed that eyonis ® LCS can accurately detect and characterize lung nodules, with exceptional results of an area under the curve (AUC) value of 0.904 versus the minimum value set as a primary endpoint for REALITY of an AUC of 0.80. Results from RELIVE released in March 2025, showed that radiologists aided by eyonis ® LCS achieved statistically significant improved performance over radiologists alone (p=0.027) and can thus improve clinicians' diagnostic accuracy in analyzing low dose computed tomography (LDCT) lung cancer screening scans. In addition, importantly, the Company believes that eyonis ® LCS can increase efficiency of LDCT scans analyses, so that healthcare professionals can process many more patients through lung cancer screening with greater confidence in diagnostic accuracy.
Lung cancer screening is recommended by the U.S. Preventive Services Task Force (USPSTF) in adults aged 50 to 80 years who have a 20 pack-year smoking history. The market opportunity includes a population of 14.5 million people in the U.S. alone, currently eligible for a lung cancer screening exam, with an existing potential reimbursement of $650 per exam with a SaMD postprocessing for characterization of malignant vs benign nodules. This represents a total addressable annual market of over $10bn. The eligible U.S. patient number is expected to rise in the coming years, driven by planned broadening of the eligibility criteria. Similarly, new lung screening program deployments are planned in Europe and Asia.
In the US alone, the direct medical costs of cancer patients care were estimated to be nearly $230 billion in 2023 1. The vast majority of cancer care costs are incurred in treating advanced cancer patients, versus preventive care such as screening that save patients' lives.
About eyonis™ LCS: eyonis ® Lung Cancer Screening (LCS) is an artificial intelligence AI-based computer aided detection and diagnosis (CADe/CADx) Software as a Medical Device (SaMD) that uses machine learning to help analyze imaging data generated with low dose computed tomography (LDCT) to aid radiologists in diagnosis of lung cancer at the earliest stages, when it can still be cured in many patients. eyonis ® LCS is the subject of two pivotal studies required for marketing approvals in the U.S. and Europe: REALITY (Clinicaltrials.gov ID: NCT06576232) and RELIVE (Clinicaltrials.gov ID: NCT06751576), both of which have been successfully completed.
About Median Technologies: Pioneering innovative software as a medical device and imaging services, Median Technologies harnesses cutting-edge AI to enhance the accuracy of early cancer diagnoses and treatments. Median's offerings include iCRO, which provides medical image analysis and management in oncology trials, and eyonis™, an AI/ML tech-based suite of software as a medical device (SaMD). Median empowers biopharmaceutical entities and clinicians to advance patient care and expedite the development of novel therapies. The French-based company, with a presence in the U.S. and China, trades on the Euronext Growth market (ISIN: FR0011049824, ticker: ALMDT). Median is also eligible for the French SME equity savings plan scheme (PEA-PME). For more information, visit www.mediantechnologies.com.
Forward-Looking Statements
This press release contains forward-looking statements. These statements are not historical facts. They include projections and estimates, as well as the assumptions on which these are based, statements concerning projects, objectives, intentions, and expectations with respect to future financial results, events, operations, services, product development and potential, or future performance.
These forward-looking statements can often be identified by the words "expects," "anticipates," "believes," "intends," "estimates" or "plans" and any other similar expressions. Although Median's management believes that these forward-looking statements are reasonable, investors are cautioned that forward-looking statements are subject to numerous risks and uncertainties, many of which are difficult to predict and generally beyond the control of Median Technologies, that could cause actual results and events to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements.
All forward-looking statements in this press release are based on information available to Median Technologies as of the date of the press release. Median Technologies does not undertake to update any forward-looking information or statements, subject to applicable regulations, in particular Articles 223-1 et seq. of the General Regulation of the French Autorité des Marchés Financiers.
1 American Cancer Society.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Business Insider
4 minutes ago
- Business Insider
The under-the-radar injections people are taking to build muscle this summer — including the 'Wolverine' shot
Peptide injections are soaring in popularity for fitness and longevity. They're marketed as a "natural" supplement for muscle-building, fat loss, recovery, and more. The FDA has been cracking down on peptide sellers, and experts say some caution is warranted. People who want to feel younger, look fitter, or perhaps slough off a little layer of belly fat have been turning to an increasingly popular kind of treatment — one you can get without a prescription. They've got obscure names like BPC-157, tesamorelin, and cerebrolysin. All it takes is a tiny needle and a little clear vial filled with injectable molecules. Welcome to the world of peptides. "Absolutely everybody's asking for it, the field is popping," Dr. Florence Comite, a longevity doctor who serves concierge medicine clients in New York City, told Business Insider. The peptide landscape is so large that it almost defies definition. The prescription drugs Ozempic and Mounjaro, often used for weight loss, are peptides. So is insulin. There are peptides in skin creams, hair products, and high-end serums marketed to women to reduce fine lines and stimulate collagen. The wildly popular fitness supplement creatine? Also a peptide. Then, there are the gym bro shots, said to boost muscle, burn fat, stimulate testosterone, and aid recovery. Demand for peptide injections — something that biohackers and longevity-seekers have already been quietly using in the shadows for decades — is booming. Patients in pockets of the country saturated with peptides, like Beverly Hills, San Diego, Silicon Valley, and Manhattan are increasingly asking their doctors: "should I try peptides?" Many physicians aren't sure what to say because there isn't a ton of great evidence around about how much peptides can really do. Plus, the FDA has been cracking down on peptide compounders in recent years. They worry that the hype is outpacing good evidence. How peptides boost your body Unlike most pills that doctors prescribe, peptides live in a more slippery area, between drug and bodily substance. A peptide is a chain of organic compounds — specifically, amino acids — that stimulate natural processes. Depending on which amino acids a peptide is made of, and how it is used, the molecule can have all kinds of impacts on how our hormones operate. Peptides can improve fertility in both men and women, tamp down inflammation, remove dangerous visceral belly fat, or help build muscle. Others are thought to help improve sleep quality, even possibly improve brain health. "What's great about peptides is that they mimic the body," said Comite, who has been working with peptides since she was a research fellow at the National Institutes of Health over 30 years ago. Since most peptides are too fragile to be formulated as pills, they are often packaged as a clear liquid in a little vial. Users learn to inject their peptides using a very fine, short needle, right at home. The popularity of peptides has soared on their reputation as ostensibly "natural" products. The idea being that, unlike other drugs or steroids, peptides are a safer choice because they're just stimulating your body to do its own thing. Taking growth hormones, for example, comes with a suite of undesirable potential side effects, like an increased risk of cancer and type 2 diabetes. What if you could just take a peptide that would stimulate your own growth hormone to make you stronger, leaner, and more energetic? "The theory is that even if you use a growth hormone stimulating peptide, your body's only going to be able to make so much growth hormone," Dr. Sajad Zalzala, a longevity physician and one of the cofounders of AgelessRx, said. "Kind of like a check valve already in place. Again, that's the theory." The peptides gym bros take to get chiseled muscles One darling peptide of gym bros and longevity fiends alike is a substance called BPC-157. It's known as the "Wolverine" shot for its perceived ability to heal you up and regenerate your body real fast like the Marvel character, Logan, after a big fight. B-P-C stands for "body protection compound." BPC-157 was first derived from stomach juices. It's being investigated to treat inflammatory bowel diseases, including Crohn's and ulcerative colitis. But the reason that athletes like it is because it's thought to reduce inflammation and improve blood flow — and perhaps do even more. There are a few other super popular peptides: Tesamorelin, an injectable peptide, is prescribed to HIV patients to reduce excess belly fat. Sermorelin is supposed to help with sleep and recovery. CJC-1295 binds to growth hormone receptors in the body, and people often take it alongside impamorelin, which stimulates the hypothalamus. The two in tandem are said to deliver better muscle gains. On Reddit and YouTube people share how they "stack" different peptides like this, taking multiple different kinds with the goal of boosting the effects of each. Peptide fans get their shots at clinics and med spas — or, for less money, online. Increasingly, people are ordering peptides that are labeled "for research only," meaning they are supposed to be used by lab workers for experimentation, and were never meant to be put into human bodies. That's partly because the FDA crackdown on peptides has intensified in recent years, just as pharmaceutical compounding (a sort of acceptable way to get knock off medications) has surged in popularity, with people seeking cheaper versions of GLP-1 drugs like Ozempic and Mounjaro. At the beginning of 2022, the FDA had a list of four peptides that they said "may present significant safety risks" and should not be compounded. By the end of 2023, there were 26. Comite thinks the FDA crackdown is a shame. She is finding it harder and harder to source compounded liquid BPC-157. She often uses a patch form of BPC-157 on herself, placing it over sore areas or injuries. Recently, she tore a calf muscle, so she's been using it there, but she also just likes how taking a little bit of it keeps her active and moving. "I use it almost every day," she said. "It's amazing for joints and everything — at a very tiny dose." Zalzala, who doesn't usually prescribe peptides, ordered some topical BPC-157 recently when his wife had a knee injury. "My wife says it works," he said, though he cautioned that it's hard to really know if that's true without more proper research. Bracken Darrell, the CEO of VF Corporation and one of Comite's patients, is also a BPC-157 convert. A self-proclaimed "basketball nut," he's on the court about three days a week. On the days when he doesn't pick up a ball, he's out cross-training on a bike or lifting weights. So when he tore his meniscus about four months ago, he was worried. Under Comite's supervision, he started taking liquid BPC-157 about three to four times a week. He told BI it was "weird" at first, learning to inject the needle into an area of skin near his knee. But, pretty soon, it was just part of his routine. "I believe it helped a lot, but it's hard to know for sure," he said. "There are people with a severely torn meniscus who don't ever play basketball again, and I'm back — I certainly wouldn't conclude that's because I'm taking BPC-157, but at a minimum it didn't hurt. And it sure seems like it helps." Proceed with caution, doctors say Even longevity doctors who prescribe and use peptides regularly agree that some folks are overdoing it, and that could be dangerous. "Proceed with caution, because you have to know the source and you have to know it's active," Comite said. "It's not like Lowe's or Home Depot where you can get stuff and you can fix the plumbing." In reality, the evidence for peptides is still murky. There are no big, randomized clinical trials like what we have for prescription drugs or vaccines. The current hype is based on anecdotal evidence, a few small human studies from decades ago, and rodent studies. "People wanna take the peptides because they're not from big pharma, they're not mainstream medicine, they gotta be better than those cockamamie doctors," Dr. Eric Topol, a cardiologist and longevity expert, said recently on the Dax Shepard podcast. "Where's the data?" For people who are using peptides, experts shared two pieces of advice: Comite urges patients to start slow. A common mistake people who are dosing themselves make is thinking that "if a little bit is good, then a lot must be better," she said. That's not the case. "Taking mega doses of tesmorelin along with testosterone causes your organs to overgrow," Comite said. Sometimes she'll see a toned gymgoer with a potbelly, and wonder whether that's due to an enlarged liver or spleen. Darrell recommends testing your peptides with an independent lab so you know what you're getting is both real and uncontaminated. Zalzala says his company started thinking about offering peptides a few years back, due to consumer demand, but they haven't yet. There are just so many peptides out there, and it's hard to tell which might be the very best. Some of the most research-backed ways to have an impact on your longevity and fitness are still the simplest anyway: eat decent amounts of fiber and protein regularly, work out — at least a couple sessions with weights each week, and cut back (or ideally, eliminate) liquid sugar in your diet like juice and soda.
New York Post
2 hours ago
- New York Post
New Mexico Pinon Coffee recalls pods due to contamination risk
A New Mexico coffee company is recalling its single-serve cups due to contamination concerns. The company, New Mexico Pinon Coffee, said it is voluntarily recalling one lot of its New Mexico Pinon Coffee Dark Pinon Single Serve Cups in a 10-count box. Advertisement The single-serve cups are filled with ground coffee flavored with natural flavorings. The affected batch is about 154 Dark Pinon 10ct Single Serve cups. The Food and Drug Administration (FDA) described the issue, saying the clear coat seal on the lid of the single-serve cups did not get applied consistently to all cups in the production run and could cause food coloring to run into the cup during brewing. The company didn't receive any reports of illnesses or injuries associated with the product. Advertisement Still, the company said it is recalling the product out of an abundance of caution. The product was sold on Amazon, according to its website. No other New Mexico Pinon Coffee products have been impacted by the recall. Consumers that have purchased these products are asked to either throw away or return the product for a refund. Advertisement New Mexico Pinon Coffee voluntarily recalled one lot of its New Mexico Pinon Coffee Dark Pinon Single Serve Cups in a 10-count box. REUTERS The company recalled the product out of an abundance of caution. New Mexico Pinon Coffee / Facebook 'At New Mexico Piñon Coffee, quality means everything to us,' the company told FOX Business in a statement. 'While the issue was isolated and poses no health risk, it didn't meet the standard of excellence you've come to expect from us.' Advertisement The company said it has already addressed the issue and taken steps to refine its process moving forward. The recall has been deemed a Class III, which is when situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences, according to the FDA.
Business Insider
6 hours ago
- Business Insider
FDA investigating death of child who received Sarepta's Elevidys
The U.S. FDA is investigating the death of an 8-year-old boy who received Elevidys, a Sarepta (SRPT) Therapeutics gene therapy for Duchenne muscular dystrophy. The death occurred on June 7, 2025. The FDA has requested and received voluntary suspension of product distribution as it investigates the safety concerns. Elevate Your Investing Strategy: Take advantage of TipRanks Premium at 50% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence. Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>>
