Latest news with #FDA-cleared
Yahoo
3 days ago
- Health
- Yahoo
Exo Launches a New Era in Disease Diagnosis with the First FDA-cleared Ultrasound AI for Detection of Pleural Effusion and Consolidation/Atelectasis
Exo Iris® now automatically detects and localizes key pulmonary findings for emergency care, showing superiority to clinicians alone SANTA CLARA, Calif., June 18, 2025--(BUSINESS WIRE)--Exo (pronounced "echo"), the leader in AI-powered, accessible medical imaging, is transforming lung disease diagnosis with another first. Now included on Exo Iris® is the first ever FDA 510(k) cleared AI for detecting pleural effusion and consolidation/atelectasis. These on-device real-time indicators empower clinicians with objective data to help detect lung diseases like pneumonia and tuberculosis at the bedside in seconds. Arun Nagdev, MD, Vice President of Clinical Affairs at Exo and a leading POCUS expert, said, "This groundbreaking real-time AI provides a remarkable assist for all clinicians at the bedside, instantly and accurately detecting fluid around the lungs or areas of collapsed lung, key markers for significant infections like pneumonia or tuberculosis. This is a great support for clinicians looking to diagnose commonly presenting patient symptoms of shortness of breath, coughing, pain, and fatigue." Said Dornoosh Zonoobi, VP of AI at Exo, "Validated in rigorous clinical studies, these AIs enabled clinicians to detect key lung findings, with sensitivity and specificity in the 'excellent' range. We're thrilled to bring these FDA-cleared firsts to all clinicians and to meaningfully impact patient diagnosis and outcomes when it matters most." These clearances mark not only a technical and regulatory milestone, but a meaningful expansion in how Exo is supporting frontline providers and patients when every second counts. Exo remains focused on delivering technology that enables critical decisions instantly, intelligently, and saves lives at scale. These clearances bring to a remarkable 14, the FDA-cleared AI indicators embedded in Iris. This sweeping portfolio is unmatched in handheld ultrasound today. All commercialized Exo AI runs directly on Exo Iris®, operates without internet, eliminates lag, and enables expert-level diagnostics in any setting. Exo is establishing a new standard in fast, accurate, and scalable point-of-care imaging. Visit Exo's website to explore these capabilities. About Exo Exo is redefining medical imaging with its advanced ultrasound platform, combining novel silicon-based hardware, tightly coupled AI, and easy-to-use collaboration software. Its handheld and soon-to-be OEM-integrated systems deliver high-performance imaging and real-time clinical intelligence, driving better, more accessible diagnostics and outcomes across diverse care settings. Follow us at @exoeffect on X, LinkedIn, Facebook, and Instagram. View source version on Contacts media@ Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Upturn
3 days ago
- Business
- Business Upturn
Hairmax Partners with Truemed to Accept FSA/HSA Payments on FDA-Cleared Laser Hair Growth Devices
Boca Raton, FL, June 18, 2025 (GLOBE NEWSWIRE) — Medical-Grade Hair Growth Devices Now Eligible for Pre-Tax Funds Hairmax, the global leader in laser hair growth technology, is proud to announce a new partnership with Truemed, enabling customers to use FSA (Flexible Spending Account) and HSA (Health Savings Account) funds to purchase eligible Hairmax hair growth medical devices. This collaboration makes Hairmax's full line of Laser Hair Growth solutions—including Laser Caps, Laser Combs, and Laser Band devices—eligible for payment with pre-tax healthcare dollars. This allows customers to save up to 30% or more instantly compared to traditional out-of-pocket spending. Hairmax laser devices are classified as FDA-cleared medical devices, clinically proven to treat hereditary hair loss and thinning in both men and women. These medical-grade devices use low-level laser therapy (LLLT), a safe, non-invasive, and drug-free treatment that stimulates hair growth, reverses thinning, and increases density and fullness. Backed by decades of clinical research, Hairmax devices are trusted by physicians and hair restoration experts around the world. 'Our partnership with Truemed aligns with our mission to make medically validated hair growth technology accessible to more people,' said Mike Nassar, President of Hairmax. 'Now, customers can invest in their hair health using pre-tax dollars, making it easier and more affordable to take action against hair loss.' At Truemed, we're excited to broaden our reach through our partnership with Hairmax, a company that shares our commitment to delivering meaningful, health-focused solutions. This collaboration reflects our mission to make health interventions more accessible by enabling HSA/FSA coverage for eligible products that truly improve lives.' – Chantel Hopper, VP of Customer Success & Marketing at Truemed. In addition to immediate savings, this partnership offers critical year-end benefits. FSA funds typically follow a 'use-it-or-lose-it' policy and must be spent before December 31st. Consumers looking to maximize the value of their remaining 2025 healthcare benefits now have a unique opportunity to invest in clinically proven hair regrowth before their funds expire. To take advantage of this opportunity, customers can now select the 'Pay with FSA/HSA' option at checkout on where Truemed will seamlessly verify eligibility and process the transaction. About Hairmax Hairmax is the pioneer and global leader in laser hair growth technology, with over 24 years of innovation and the most FDA clearances in the industry. Hairmax devices are clinically proven and physician-recommended for the treatment of hereditary hair loss and thinning hair. The brand's comprehensive portfolio includes laser devices, hair care, and supplements designed to restore confidence and support a healthy hair growth journey. About Truemed About Us blurb: Over $140 billion in HSA/FSA funds sit untouched, with many account holders unaware that their dollars can be spent on more than just prescriptions, doctor's visits, and traditional 'sick-care.' Truemed helps qualified Americans unlock the full potential of these accounts, enabling them to use pre-tax funds on products that help cure, treat, mitigate, and prevent chronic disease, like fitness equipment, supplements, red light therapy, and more. Truemed's curated marketplace and seamless process make it easier to spend smarter and live healthier. Learn more at . Learn more at Disclaimer: The above press release comes to you under an arrangement with GlobeNewswire. Business Upturn takes no editorial responsibility for the same. Ahmedabad Plane Crash
Business Wire
3 days ago
- Health
- Business Wire
Exo Launches a New Era in Disease Diagnosis with the First FDA-cleared Ultrasound AI for Detection of Pleural Effusion and Consolidation/Atelectasis
SANTA CLARA, Calif.--(BUSINESS WIRE)--Exo (pronounced 'echo'), the leader in AI-powered, accessible medical imaging, is transforming lung disease diagnosis with another first. Now included on Exo Iris® is the first ever FDA 510(k) cleared AI for detecting pleural effusion and consolidation/atelectasis. These on-device real-time indicators empower clinicians with objective data to help detect lung diseases like pneumonia and tuberculosis at the bedside in seconds. These clearances bring to a remarkable 14, the FDA-cleared AI indicators embedded in Iris. Exo AI runs directly on Exo Iris®, operates without internet, eliminates lag, and enables expert-level diagnostics in any setting. Share Arun Nagdev, MD, Vice President of Clinical Affairs at Exo and a leading POCUS expert, said, ' This groundbreaking real-time AI provides a remarkable assist for all clinicians at the bedside, instantly and accurately detecting fluid around the lungs or areas of collapsed lung, key markers for significant infections like pneumonia or tuberculosis. This is a great support for clinicians looking to diagnose commonly presenting patient symptoms of shortness of breath, coughing, pain, and fatigue.' Said Dornoosh Zonoobi, VP of AI at Exo, ' Validated in rigorous clinical studies, these AIs enabled clinicians to detect key lung findings, with sensitivity and specificity in the 'excellent' range. We're thrilled to bring these FDA-cleared firsts to all clinicians and to meaningfully impact patient diagnosis and outcomes when it matters most. ' These clearances mark not only a technical and regulatory milestone, but a meaningful expansion in how Exo is supporting frontline providers and patients when every second counts. Exo remains focused on delivering technology that enables critical decisions instantly, intelligently, and saves lives at scale. These clearances bring to a remarkable 14, the FDA-cleared AI indicators embedded in Iris. This sweeping portfolio is unmatched in handheld ultrasound today. All commercialized Exo AI runs directly on Exo Iris®, operates without internet, eliminates lag, and enables expert-level diagnostics in any setting. Exo is establishing a new standard in fast, accurate, and scalable point-of-care imaging. Visit Exo's website to explore these capabilities. About Exo Exo is redefining medical imaging with its advanced ultrasound platform, combining novel silicon-based hardware, tightly coupled AI, and easy-to-use collaboration software. Its handheld and soon-to-be OEM-integrated systems deliver high-performance imaging and real-time clinical intelligence, driving better, more accessible diagnostics and outcomes across diverse care settings. Follow us at @exoeffect on X, LinkedIn, Facebook, and Instagram.
New York Post
4 days ago
- Health
- New York Post
Is the Solawave red light therapy wand worth it? I tested it for 21 days
New York Post may be compensated and/or receive an affiliate commission if you click or buy through our links. Featured pricing is subject to change. If you've been on TikTok, Instagram, or in an Ulta Beauty skincare aisle lately, you've probably seen the Solawave Wand. It's a compact, FDA-cleared skincare tool that promises to reduce fine lines, fade dark spots, and deliver brighter skin through red light therapy, microcurrent stimulation, warming massage, and facial sculpting, all in one tiny device. Many people online have found this tool to make a truly significant difference. But does it really work, or is it just another beauty gadget we'll all forget about in six months? I spent three weeks using the Solawave Wand daily to find out. Amazon Pros: Compact and travel-friendly Reduces redness and post-acne inflammation Easy to incorporate into nightly skincare Doesn't require a full face mask Cons: Time-consuming if you want to treat the full-face Not as strong as professional-grade red light tools Requires patience and consistency Combining red light therapy, galvanic current, therapeutic warmth, and facial massage, this multitasking wand is designed to reduce fine lines, dark circles, and puffiness to leave skin noticeably smoother and more radiant. Pair it with the Solawave Renew Complex Serum, recommended by the brand, to achieve a soothing, all-natural formula infused with aloe vera, hyaluronic acid, and other beneficial ingredients, maximizing the benefits of each treatment. In just three minutes per area, you'll feel the warmth and see the glow as it targets the forehead, under eyes, cheeks, and jawline with its 180-degree rotating head. It's lightweight, rechargeable, and travel-ready with a protective case. Overall, I highly recommend it, and it comes in three lovely shades of rose gold (which I enjoyed), gold, and charcoal. If you're interested in testing other competitors, read our LYMA Laser review or consider shopping full-face LED masks recommended by dermatologists to cover the entire face with one hit. Number of therapies: Four | Battery life: Up to a week | Results: Up to 21 days Solowave Review Advertisement Does Solawave work? Yes, but it depends on what you're using it for to get quick and easy results. The Solawave is a handheld skincare wand designed to deliver results that mimic in-office treatments but from your bathroom mirror. The company has also launched a Solawave mask ($349), which offers full-face red light exposure. However, the wand remains one of its most popular products, thanks to its portability; I even brought it along on weekend getaways. It worked wonders before my friend's baby shower, right before I (regrettably) popped a very juicy zit. I used the Solawave, and the blemish was barely noticeable the next morning. How to use a Solawave A lot of people are curious about how to use a Solowave. I read the directions and thought it would be complicated, but it was incredibly easy to use. Just plug it in to charge for up to two hours. Once it's ready, press the button and boom, as Sabrina Carpenter says, 'hot to go.' It's built to be used for just a few minutes per day, starting at three or if you begin to feel uncomfortable, but it can eventually be worked up to 12 minutes over time in one setting. Emma Sutton-Williams But before we dive in any further, I should give you a brief history of my skin so you can compare it to yours. As a child, I was burned with 3-degree burns, and later, a windshield of glass went through my face, so it has more uneven bumps and scarring that won't be taken away without plastic surgery and most definitely not a wand. And don't get me started on acne growing up — it was a pimple patch. While testing this wand, I've also been dealing with a rollercoaster of stress due to health issues, things entirely out of my control. Like clockwork, my skin tends to react under pressure, so I kept that in mind while testing. The Solawave Wand combines four skin therapies: Red light therapy to stimulate collagen and reduce inflammation Microcurrent to tone facial muscles and lift Facial massage to depuff and stimulate circulation Therapeutic warmth to help with product absorption and relaxation Begin by cleansing your face thoroughly and then gently pat it dry. Solowave recommends using its 2-in-1 Face Cream & Neck Cream or you can buy the 4-in-1 Red Light Therapy Wand & Activating Serum Kit for a more effective session. The substance feels velvety and a bit thick for my preference, but anything to help improve my fine lines and even out my skin tone. I also like that it helps the wand glide effortlessly across my skin. I tested it by applying it to half of my face and the other half with my standard moisturizer. I wish I could tell you I saw a night and day difference, but I haven't noticed any massive changes — yet. However, these things do take time, and the ingredients in the serum are supposed to brighten dark spots and leave the skin feeling refreshed and balanced. @solawave Get more from your light therapy with LightBoost topicals! Works with any device brand. ♬ original sound – Solawave – Solawave Using any water-based serum will work; however, avoid oils, as they can interfere with the microcurrent. If you're unfamiliar with microcurrents, it's a non-invasive treatment that mimics the natural currents in your body to boost cellular activity and reduce the appearance of aging. Who doesn't like that? The wand activates automatically when it touches your skin, so once it's on, slowly glide it over your face in upward and outward motions. After each use, wipe the wand clean with a soft cloth and recharge it as needed. Final Verdict If you're looking for a convenient, effective red light therapy tool under $200 that targets red spots, the Solawave Wand is one of the best options on the market. It's easy to use, visibly helps with redness, and adds a calming moment to your nighttime routine. I wanted my Solawave before and after shots to be mind-blowing, but there is a very minimal difference at first glance. But when my skin was agitated, it reduced the redness significantly. It's not a miracle worker, and it won't give you laser-like results because nothing except lasers can smooth over your skin with a deep peel. It will help your skin recover faster, glow a little more, and feel noticeably healthier over time. And for that, I'm keeping it in my skincare drawer. How we tested Over the course of three weeks, I used the Solawave 4-in-1 Facial Wand nightly as part of a consistent evening skincare routine. Each session lasted five minutes, focusing on areas with fine lines, puffiness, and uneven tone. I paired the wand with the brand's Activated Serum and evaluated changes in skin texture, hydration, and overall glow, tracking both immediate post-use effects and longer-term improvements. FAQ How often should I use the Solawave wand? For best results, it's recommended to use the wand 3–5 times per week for about 5 minutes per session. Consistency is key to seeing lasting improvements in tone and texture. We also suggest using it for 8 weeks before you make up your mind. Can I use the Solawave wand every day? Yes, many users (myself included) use it nightly. Just make sure to listen to your skin. If you experience irritation, take a day or two off, as it can cause your skin to become red if you're not careful. Do I need to use the Renew Complex Serum with it? While not required, the Renew Complex Serum is designed to enhance conductivity and results. Using a conductive serum ensures the wand's microcurrent function works properly. When will I start seeing results? Some people notice a glow or temporary lift after the first few uses. More noticeable improvements — like reduced puffiness or fine lines, typically show up after consistent use for 2–3 weeks. Is it safe for sensitive skin? Generally, yes. The wand is designed to be gentle, but if you have very sensitive skin or conditions like rosacea, it's best to do a patch test or consult your dermatologist. Starting with shorter sessions may also help minimize any reaction. Can I use it over acne or breakouts? It's best to avoid active breakouts, especially if they're inflamed. Instead, use the wand to support healing in surrounding areas and return to breakout spots once the skin has calmed down. This article was written by Emma Sutton-Williams, New York Post Commerce Writer/Reporter and resident fashionista. Emma is one of the best-dressed ladies in The Post's office, and also known for finding an unbelievable deal on any one of her stylish outfits. Divulging on everything from the most-popular and most-underrated purse brands to her honest thoughts on Kim Kardashian's Skims undergarments and apparel, Emma has cultivated an eye for style and an expertise for identifying the clothes and accessories worth your coin. At the same time, she proudly models the products she picks so you can see their fit and function first-hand. Emma has been creating shopping guides for The Post since 2024, and previously held bylines in Rolling Stone, Oprah Daily, Parents, InStyle, StyleCaster and more. Looking for a headline-worthy haul? Keep shopping Post Wanted.
Forbes
4 days ago
- Health
- Forbes
Omnilux LED Face Mask Review: An Easy-To-Use Tool That Gives Visible Results
There are few beauty devices as popular as LED face masks right now—they promise a host of anti-aging and skin-rejuvenating benefits and require minimal treatment time. When I had the opportunity to test out the Omnilux Contour Face, I jumped at the chance to press rewind on my dull, splotchy skin. The device uses red and near-infrared lights to reduce fine lines, improve hyperpigmentation and stimulate collagen production. After using it for six weeks, my smile lines appear less noticeable, and I've noticed a significant reduction in overall skin redness. For $395, the Omnilux Contour Face is pricey, but it's a long-term investment—it's meaningfully cheaper than in-office treatments and incredibly convenient because you can wear it in the comfort of your own home. It requires 10 minutes of use three to five times per week. While you need to wear this mask consistently to see results, if you're looking to minimize acne scarring, decrease fine lines and improve skin texture, the Omnilux LED mask is a worthwhile skincare tool. (Read our full review of the best LED face masks.) Light modes: Red, near-infrared | Skin concerns: Fine lines, redness, wrinkles, hyperpigmentation | Wireless: Yes (with connected controller) | Number of LEDs: 132 | Usage: 10 minutes, three to five times per week Best for: Skip if: This FDA-cleared device is hands-free and powered by a lightweight, palm-sized controller that you charge before use. It's pre-programmed to provide ten-minute sessions, and you wear it from three to five times per week. It's recommended that you use the Omnilux Contour Face for four to six weeks and then continue with maintenance. The device comes with four attachments to allow for international use in different outlets, as well as a fabric storage bag, making it very easy to pack for travel. While all LED masks on the market are pain-free and require no downtime (I also reviewed the CurrentBody Series 2 LED Light Therapy Face Mask), the Omnilux device stands out for comfort. It's made with soft, flexible silicone as opposed to rigid plastic like some other LED masks, so it flexes to the contours of your face when you tighten and secure the two rear Velcro straps. The nose area is designed to accommodate various nose shapes, and the mask is shaped so that it doesn't press uncomfortably on any specific area of your face while you wear it. While some beauty devices may have dubious results, LED masks are popular for their efficacy. The Omnilux device features 132 medical-grade LED lights in red (633nm) and near-infrared (830nm) wavelengths that are strategically positioned around your forehead, cheeks, chin and nose. It works to reduce wrinkles, improve acne, decrease inflammation, refine skin texture and stimulate collagen production. In clinical studies after four weeks, 95% of Omnilux Contour Face users reported visibly brighter and plumper skin, 98% reported firmer skin and 96% said their fine lines appeared less visible after 12 treatments. Setting up the Omnilux Contour Face is very simple. I plugged in the controller without the connected mask to charge and waited for the three lights to illuminate. I then connected the mask to the controller and securely attached it to my face with the two straps—one over my ponytail and the other at the nape of my neck. Since I am generally rushing in the morning to get organized for the day, I preferred to wear the Omnilux Contour Face at night before bed. I'd prep my face by washing it and patting it dry. I'd then wear the device with my eyes shut while listening to the TV or would sometimes check emails on my phone during my ten-minute session. Because the mask doesn't come with eye inserts, however, the bright light would sometimes irritate my eyes if I didn't keep them closed. During testing, the mask didn't cause my face to feel hot, and the flexible silicone was incredibly comfortable to wear—it didn't create annoying pressure points anywhere, and it didn't feel suffocating. The device would also turn off automatically at the end of each pre-programmed session, which was a nice feature. My only gripe is that the straps were too thin to keep it securely on my face if I decided to move around; thicker straps or an additional strap would help address this issue. After use, I gently wiped down the mask with a slightly damp microfiber cloth, let it air dry, and then placed it back in the provided storage bag to prevent it from attracting any lint. During the first four weeks of use, I wore the device five times per week; during weeks five and six, I only wore it three times per week. The company recommends using the device for at least four weeks to see results. While I'm skeptical of most beauty devices because I've historically been frustrated by inflated promises, the Omnilux Contour Face created visible results. I am in my 40s and come from an Irish and German background—what this combination means for me is that I have fine lines, uneven skin tone and an unfortunate amount of skin redness that seems to be increasing with age. I like that the Omnilux mask is non-invasive and treats visible signs of aging and damaged skin, which I have a fair amount of after working as a lifeguard while in high school and college. I found that it made my skin appear more plump and less dull, it seemed to visibly reduce the parentheses lines around my mouth, and it decreased the redness and inflammation on my face, especially around my nose and on my cheeks. It also seems to have kept my intermittent bouts with adult acne at bay. I plan to continue use it weekly, albeit not as frequently, to maintain results. As a magazine writer, I've spent twenty years writing about lifestyle topics, including fashion and beauty. I've written about and tested microcurrent devices, retinol creams, the best skincare for women over 50 and much more. When it comes to LED face masks, I've also tested the CurrentBody LED Face Mask and compared it to the Omnilux. This story was assigned and edited by deputy editor Jane Sung, who oversees the beauty, fashion and travel verticals for Forbes Vetted. An industry veteran with over 20 years of experience, she has produced a wide variety of skincare stories, including a roundup of the best LED face masks and the best at-home laser hair removal devices. For this story, I also interviewed board-certified dermatologist Dr. Rhonda Q. Klein of Modern Dermatology for her insights into what makes LED face masks worthwhile skincare devices. How Often Should You Use The Omnilux LED Face Mask? The brand recommends using the device up to three to five times per week for a minimum of four weeks for best results. Maintenance treatments can then be carried out as desired. Is The Omnilux LED Face Mask FDA Cleared? Yes, the Omnilux LED Face Mask is FDA cleared. What this means is that the Food and Drug Administration has reviewed the device and determined it is safe for its intended purpose. FDA Approval requires an additional, more stringent review process. How Long Do Results From Using An LED Face Mask Last? Unfortunately, you can't just put in the time with an LED face mask in the first four to six weeks and then stop using it and expect to see continued results. Much like going to the gym, consistency is key. A good plan is to jump start the process in the first four to six weeks of use, and then continue with maintenance.
