Latest news with #DeNovo
Yahoo
02-06-2025
- Business
- Yahoo
ADDING MULTIMEDIA Clairity Becomes the First FDA-Authorized AI Platform for Breast Cancer Prediction – Historic Milestone for Women's Health
CLAIRITY BREAST provides clinicians with a first-in-class, novel platform for identifying future risk of breast cancer A milestone in equitable healthcare, with potentially life-saving insights from a screening mammogram alone FDA grants De Novo authorization for new device for future five-year breast cancer risk prediction, based on an image alone BOSTON & CHICAGO, June 02, 2025--(BUSINESS WIRE)--Clairity, Inc., a digital health innovator advancing AI-driven healthcare solutions, has received U.S. Food and Drug Administration (FDA) De Novo authorization for CLAIRITY BREAST, a novel, image-based prognostic platform designed to predict five-year breast cancer risk from a routine screening mammogram. With this authorization, Clairity is planning to launch among leading health systems through 2025 – propelling a new era of precision medicine in breast cancer. Each year, more than 2.3 million new cases of breast cancer are diagnosed worldwide1, including over 370,000 cases in women in the United States2. Early detection and risk reduction are powerful tools to save lives, but their most effective deployment depends on accurate risk assessment. Most risk assessment models rely heavily on age and family history to predict risk. However, 85% of women diagnosed with breast cancer have no family history, and nearly half have no identifiable risk factors3,4. In addition, traditional risk models, built on data from predominantly European Caucasian women, have not generalized well to women of diverse racial and ethnic backgrounds5. CLAIRITY BREAST analyzes subtle imaging features on screening mammograms that correlate with future breast cancer risk, making early risk prediction feasible based on a screening mammogram alone. The result is a validated five-year risk score delivered to healthcare providers through existing clinical infrastructures, supporting more personalized follow up care. "For more than 60 years, mammograms have saved lives by detecting early-stage cancers. Now, advancements in AI and computer vision can uncover hidden clues in the mammograms – invisible to the human eye – to help predict future risk," said Dr. Connie Lehman, Founder of Clairity, who is also a breast imaging specialist at Mass General Brigham. "By delivering validated, equitable risk assessments, we can help expand access to life-saving early detection and prevention for women everywhere." "Personalized, risk-based screening is critical to improving breast cancer outcomes, and AI tools offer us the best opportunity to fulfill that potential," said Dr. Robert A. Smith, Senior Vice President of Early Cancer Detection Science at the American Cancer Society. "By integrating AI models that assess individual risk, we can better identify women at higher risk, and those who may benefit from supplemental screening methods, such as MRI, improving early detection and more effective prevention strategies." "Clairity's FDA authorization is a turning point for more women to access the scientific advances of AI-driven cancer risk prediction," said Larry Norton, Founding Scientific Director of the Breast Cancer Research Foundation. "Breast cancer is rising, especially among younger women, yet most risk models often miss those who will develop the disease. Now we can ensure more women get the right care at the right time." "What makes the availability of CLAIRITY BREAST a true sea change is that we're now predicting risk of future cancer from patterns in breast tissue, in an otherwise normal screening, before it's even there," said Jeff Luber, CEO of Clairity. "CLAIRITY BREAST is designed to fit seamlessly into the current clinical infrastructure to help providers scale precision prevention – with the goal of reducing late-stage diagnoses, lowering costs, and saving more lives." The FDA De Novo authorization positions CLAIRITY BREAST as a first-in-class platform within the $63 billion global breast cancer prediction market, ushering in a new standard for personalized, risk-based screening and cancer prevention. Be the first to know when it launches, and how you can get it: About CLAIRITY BREAST CLAIRITY BREAST, authorized under the name Allix5, is a mammography-based AI risk prediction platform that analyzes imaging data at the pixel level to identify individuals at elevated risk of future breast cancer. The AI model behind CLAIRITY BREAST was trained on millions of images and validated across more than 77,000 mammograms from five geographically distinct screening centers – including hospital-based and free-standing facilities – that collectively serve a diverse patient population, with validation anchored in five-year outcome data. To learn more about indications for use, visit: Clairity's first-in-class platform was designed to complement existing clinician workflows, making it uniquely positioned to address, at scale, the widespread shortfalls in breast cancer risk assessment and cancer prevention. About Clairity Founded in 2020 and headquartered in Boston, Massachusetts, Clairity, Inc. is transforming healthcare risk assessment through the power of artificial intelligence and deep learning. Founded by Dr. Connie Lehman, backed by Santé Ventures and ACE Global Equity, Clairity's technology can uncover subtle patterns in routine images that are invisible to the human eye, enhancing risk prediction to empower clinicians and their patients with actionable, personalized insights. Clairity's mission is to shift the standard of care from late-stage treatment to proactive prevention. To learn more, visit us at | LinkedIn ____________________ References: 1 2 3 4 5 View source version on Contacts Media Contact: Nina GillLaVoieHealthScience781-856-3103ngill@ Investor Interest: Sam LibbyTCB Capital Advisors973-563-3141samlibby@ 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 Wire
30-05-2025
- Health
- Business Wire
FDA Grants De Novo Clearance for Reflow Medical's Spur ® Peripheral Retrievable Stent System
SAN CLEMENTE, Calif.--(BUSINESS WIRE)--Reflow Medical, Inc., a leading developer of innovative medical devices focused on complex cardiovascular disease, announced that the U.S. Food and Drug Administration (FDA) has granted De Novo clearance for the company's Spur Peripheral Retrievable Stent System, a unique clinical solution for the treatment of de novo or restenotic lesions following predilatation in patients with infrapopliteal arterial disease. This first-of-its-kind technology offers a truly novel approach to treating patients with BTK CLTI disease. Share The Spur Stent System is the first and only retrievable stent system that features a self-expanding stent with an integrated dilatation balloon catheter on an over-the-wire system. It is designed for controlled lesion penetration and treatment through a series of radially expandable spikes. Known as Retrievable Scaffold Therapy (RST), the spikes on the Spur Stent penetrate the lesion to increase the acute luminal diameter and modify the lesion morphology to change vessel compliance and reduce vessel recoil effect. Results of the recently concluded DEEPER REVEAL clinical trial (NCT05358353) to evaluate the Reflow Medical Spur Stent System for below-the-knee (BTK) treatment of chronic limb-threatening ischemia (CLTI), demonstrated that following predilatation, the Spur Stent System achieved a 99.2% technical success 1 rate and 97.0% freedom from MALE 2 and POD 3 at 30 days. 'Clinical data submitted to the FDA demonstrated the safety and efficacy of the Spur Stent System,' said Mahmood K. Razavi, MD, FSIR, FSVM, who serves as Director of the Clinical Trials and Research Center at St. Joseph Heart and Vascular Center in Orange, California. 'This novel device will be a valuable and innovative expansion of our treatment toolbox as a unique device for the treatment of complex BTK disease,' he added. S. Jay Mathews, MD, MS, FACC, FSCAI, the Cath Lab Director at Bradenton Cardiology/Manatee Memorial Hospital in Bradenton, Florida, commented, 'It's exciting to see the clinical success of the DEEPER REVEAL trial enabling the De Novo clearance of the Spur Stent System. This first-of-its-kind technology offers a truly novel approach to treating patients with BTK CLTI disease. As an adjunct to standard balloon angioplasty, Spur RST enables us to address this complex disease in a more effective way, achieving these outcomes that go beyond what PTA alone can deliver.' Both Dr. Mathews and Dr. Razavi were lead Principal Investigators for the study, which was conducted at 49 centers in the U.S. and enrolled 130 patients. 'Extensive research and development, which laid the groundwork for the DEEPER REVEAL trial, enabled the creation and clinical validation of the Spur Stent System, an innovative mechanical endovascular device engineered to enhance lesion penetration and optimize the treatment of BTK peripheral arterial disease,' said Teo Jimenez, Senior Vice President of R&D at Reflow Medical. According to Reflow Medical CEO and Co-Founder, Isa Rizk, 'The FDA's De Novo clearance, following positive clinical trial results in patients with CLTI, enables us to provide physicians with an effective therapeutic option for this growing patient population. We are fully prepared to launch our innovative technology through our dedicated sales force, ensuring it promptly reaches physicians to support patients.' The FDA decision will be available on their website under DEN240048. About Reflow Medical, Inc. Reflow Medical is a global company that partners with leading physicians to develop innovative technologies addressing unmet clinical needs in the endovascular treatment of complex cardiovascular disease. The company's portfolio includes coronary and peripheral microcatheters, crossing catheters, and a revolutionary system known as Retrievable Scaffold Therapy (RST). Products include the CoraCatheters line, available in the U.S. only; the Wingman™, Spex ® and Spex LP, available in the U.S., CE Mark and CE Mark-accepting countries and selected markets; and the Spur ®. Spur received CE Mark approval for the treatment of restenotic lesions in below-the-knee arteries, when used in conjunction with a commercially available drug-coated balloon. Reflow Medical is headquartered in San Clemente, California. 1. Technical success defined as less than 30% residual stenosis by visual estimation; 2. Major adverse limb events; 3. Perioperative death
Yahoo
30-05-2025
- Business
- Yahoo
FDA Grants De Novo Clearance for Reflow Medical's Spur® Peripheral Retrievable Stent System
SAN CLEMENTE, Calif., May 30, 2025--(BUSINESS WIRE)--Reflow Medical, Inc., a leading developer of innovative medical devices focused on complex cardiovascular disease, announced that the U.S. Food and Drug Administration (FDA) has granted De Novo clearance for the company's Spur Peripheral Retrievable Stent System, a unique clinical solution for the treatment of de novo or restenotic lesions following predilatation in patients with infrapopliteal arterial disease. The Spur Stent System is the first and only retrievable stent system that features a self-expanding stent with an integrated dilatation balloon catheter on an over-the-wire system. It is designed for controlled lesion penetration and treatment through a series of radially expandable spikes. Known as Retrievable Scaffold Therapy (RST), the spikes on the Spur Stent penetrate the lesion to increase the acute luminal diameter and modify the lesion morphology to change vessel compliance and reduce vessel recoil effect. Results of the recently concluded DEEPER REVEAL clinical trial (NCT05358353) to evaluate the Reflow Medical Spur Stent System for below-the-knee (BTK) treatment of chronic limb-threatening ischemia (CLTI), demonstrated that following predilatation, the Spur Stent System achieved a 99.2% technical success1 rate and 97.0% freedom from MALE2 and POD3 at 30 days. "Clinical data submitted to the FDA demonstrated the safety and efficacy of the Spur Stent System," said Mahmood K. Razavi, MD, FSIR, FSVM, who serves as Director of the Clinical Trials and Research Center at St. Joseph Heart and Vascular Center in Orange, California. "This novel device will be a valuable and innovative expansion of our treatment toolbox as a unique device for the treatment of complex BTK disease," he added. S. Jay Mathews, MD, MS, FACC, FSCAI, the Cath Lab Director at Bradenton Cardiology/Manatee Memorial Hospital in Bradenton, Florida, commented, "It's exciting to see the clinical success of the DEEPER REVEAL trial enabling the De Novo clearance of the Spur Stent System. This first-of-its-kind technology offers a truly novel approach to treating patients with BTK CLTI disease. As an adjunct to standard balloon angioplasty, Spur RST enables us to address this complex disease in a more effective way, achieving these outcomes that go beyond what PTA alone can deliver." Both Dr. Mathews and Dr. Razavi were lead Principal Investigators for the study, which was conducted at 49 centers in the U.S. and enrolled 130 patients. "Extensive research and development, which laid the groundwork for the DEEPER REVEAL trial, enabled the creation and clinical validation of the Spur Stent System, an innovative mechanical endovascular device engineered to enhance lesion penetration and optimize the treatment of BTK peripheral arterial disease," said Teo Jimenez, Senior Vice President of R&D at Reflow Medical. According to Reflow Medical CEO and Co-Founder, Isa Rizk, "The FDA's De Novo clearance, following positive clinical trial results in patients with CLTI, enables us to provide physicians with an effective therapeutic option for this growing patient population. We are fully prepared to launch our innovative technology through our dedicated sales force, ensuring it promptly reaches physicians to support patients." The FDA decision will be available on their website under DEN240048. About Reflow Medical, Inc. Reflow Medical is a global company that partners with leading physicians to develop innovative technologies addressing unmet clinical needs in the endovascular treatment of complex cardiovascular disease. The company's portfolio includes coronary and peripheral microcatheters, crossing catheters, and a revolutionary system known as Retrievable Scaffold Therapy (RST). Products include the CoraCatheters line, available in the U.S. only; the Wingman™, Spex® and Spex LP, available in the U.S., CE Mark and CE Mark-accepting countries and selected markets; and the Spur®. Spur received CE Mark approval for the treatment of restenotic lesions in below-the-knee arteries, when used in conjunction with a commercially available drug-coated balloon. Reflow Medical is headquartered in San Clemente, California. 1. Technical success defined as less than 30% residual stenosis by visual estimation; 2. Major adverse limb events; 3. Perioperative death View source version on Contacts Jennifer Carlylejcarlyle@ 949-481-0399
Yahoo
28-05-2025
- Business
- Yahoo
CEO maligns FDA delays over depression device treatments' US market entry
The CEO of Flow Neuroscience has called out the US Food and Drug Administration (FDA) for market entry delays for clinically validated devices for treating depression. The UK company's CEO pointed out that in spite of these delays, the US market is instead 'flooded' with wellness products that lack clinical validation and make 'vague' claims about their ability to 'improve focus' or relieve the symptoms of depression. Transcranial direct current stimulation (tDCS) devices such as the one developed by Flow, which gained a breakthrough device designation from the FDA in 2022, have been proposed as a new treatment in major depressive disorder (MDD). In a recent international clinical trial of Flow's device, the results of which were recently published in Nature Medicine, 57% of patients experienced remission from depressive symptoms and no severe side effects reported, while 92% of participants had a clinically significant response to the treatment. Despite the breakthrough designation, Flow remains unavailable in the US. 'People can easily purchase wellness devices with no clinical evidence behind them, while science-backed companies are still waiting on regulatory approval,' said Flow Neuroscience CEO Erin Lee. 'This kind of regulatory imbalance doesn't just hold back innovation, but ultimately harms patients.' Lee pointed out that the FDA system is 'fundamentally inconsistent' and called its approach 'two standards under one roof' given the FDA demands extensive US-based trials from devices that already meet international medical standards, yet at the same time, companies can 'flood the wellness category with unverified claims and no clinical scrutiny'. A recent whitepaper testifies to this gap. It found that 85-90% of medical devices in the US reach market via the 510(k) pathway, which doesn't require clinical trials, while novel neuromodulation devices like tDCs are typically pushed into De Novo or Premarket Approval routes, requiring multi-year trials even if they have existing international approval. Lee concluded: 'In practice, what this means is that people in Sweden, the UK, or even Hong Kong can access a device like Flow, while Americans are left with expensive gadgets that claim to stimulate the vagus nerve or boost brainwaves, without any evidence.' The FDA did not immediately respond to a request for comment. "CEO maligns FDA delays over depression device treatments' US market entry" was originally created and published by Medical Device Network, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. 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
News.com.au
21-05-2025
- Business
- News.com.au
ASX medtechs chasing FDA De Novo for a shot at big US markets
Nanosonics scores FDA De Novo approval in March EMVision is also targeting De Novo for its brain scanner The company's big potential in the US When Nanosonics (ASX:NAN) landed FDA De Novo clearance for its CORIS system back in March, the market took notice, and for good reason. The CORIS system is not only a world-first device designed to clean the complex inner channels of endoscopes. It also walked the De Novo path – a route the US FDA reserves for genuinely new technologies. De Novo (which literally means "from new" in Latin) is not a simple clearance. This one is for devices without a predicate – i.e. no similar product already on the market. That means the FDA has to classify and assess the technology from the ground up. In short: it's hard to get, and a big deal if you do. Investors responded in kind, with Nanosonics' share price jumping by 13% on the news that day. Other ASX medtechs are also currently chasing De Novo clearance. PainChek (ASX:PCK), for instance, is waiting on a mid-2025 decision for its pain-assessment app. TrivarX (ASX:TRI) is also pursuing the De Novo path, with a pivotal trial in the works for its mental health wearable. Just a few years earlier, in 2016, another Aussie medtech, ProMedicus (ASX:PME), also made inroads in the States, thanks to a key partnership with none other than the prestigious Mayo Clinic. Since 2016, ProMedicus shares have gone on a jaw-dropping tear, up by more than 9000% today. Filling the CT and MRI gap Now, the $145m market capped EMvision Medical Devices (ASX:EMV) is quietly walking a similar path. We're not suggesting EMvision is about to pull a Nanosonics or do a ProMedicus victory lap. But, with De Novo ambitions of its own and an eye on cracking the US, it's probably one stock worth keeping on the radar. The Brisbane-based company is in the thick of a pivotal trial at Mayo Clinic in Florida, UTHealth in Houston, as well as the Royal Melbourne in Australia. Mayo Clinic joined the trial after clinicians there reached out to the company, having come across EMVision's EMU product. EMU is a portable, bedside brain scanner that aims to help detect strokes and bleeds where access to CT and MRI is limited or simply not practical. 'It has a physical footprint similar to a cart-based ultrasound system, and it's designed to support point-of-care diagnosis for stroke and stroke-like symptoms," EMV CEO Scott Kirkland told Stockhead. The company is also currently chasing De Novo approval for the device. But if you're wondering whether this could eventually compete with CT or MRI, the answer is… not really. And that's the point. 'We're not trying to replace a CT or an MRI. In fact, we're here to fill a gap where they are not available," said Kirkland. EMU's trials and First Responder EMU isn't just a 'me-too' device – a term for products or drugs that make minor modifications from a better known prototype. It's going after stroke, one of the biggest health problems on the planet. One in four adults will suffer a stroke in their lifetime, and most don't walk away unscathed – two out of three lead to lasting disability. What makes it worse is that many patients, especially in the regions, can't get timely access to imaging. The nearest CT could be hours away. EMU is now in a pivotal trial, aiming to enrol 300 patients across six sites; three up and running, three more to come. The primary endpoint of the trials is its ability to detect the presence or absence of haemorrhage. 'We have a gold-standard reference diagnosis expert panel that assesses all the ground truths, which are then compared with our diagnostic output to determine our sensitivity and specificity. "The minimum performance criteria is to exceed 80% sensitivity and 80% specificity. That's the minimum, but there's nothing to stop us from going as high as possible." Stroke's not the only target for EMV. One of EMVision's four trials is also focused on traumatic brain injury. Then there's the First Responder. It's backpack-sized, battery-powered, and built for use in ambulances and aeromedical units, not hospital wards. The device has already been tested with the Royal Flying Doctor Service and the Australian Stroke Alliance in outback South Australia. Next up is a trial inside a Melbourne stroke ambulance, the kind with a CT scanner in the back. 'First Responder doesn't require a specialist operator, such as a radiographer, and the output can be sent back to a neurologist to guide decision making – whether that's triage, transfer or potentially treatment at the scene," Kirkland said. Mapping the US market Crucially, EMVision isn't just taking a punt on the US, it has a clear plan for where its technology belongs. Kirkland reckons there are around 10,000 EMU opportunities across US stroke wards, ICUs and EDs. 'Within our first targets, there are really two ends of the spectrum. "One is comprehensive and primary stroke centre, the other are critical access hospitals, which are small regional clinics with 25 beds or less,' he explained. The First Responder has an even bigger runway – about 60,000 units, covering both road and air ambulances. And every scan comes with a consumable (a cap and coupling media), adding recurring revenue of around US$25 per scan for EMU, and closer to US$50 for First Responder. Kirkland is clear-eyed about what comes next. 'We've guided that we expect to head to the market kind of late calendar year 2026,' he said. 'It's a very, very large market. You can do the numbers, and if we can achieve 10% of the market, it is a very large business indeed.' With De Novo ambitions, a top-shelf US trial, and the Mayo Clinic in its corner, EMVision is playing a long game. No aggressive claims, just data collection and careful steps. But in the world of medtech, careful steps in the right direction can sometimes lead to very big leaps.
