Latest news with #FDA-cleared
Business Wire
4 hours ago
- Health
- Business Wire
Nalu Medical Achieves National Payer Milestone with Aetna Coverage for PNS Therapy
CARLSBAD, Calif.--(BUSINESS WIRE)--Nalu Medical, Inc., a leader in miniaturized neuromodulation therapies, is pleased to announce that Aetna Inc. has issued an updated medical policy designating the Nalu Neurostimulation System as medically necessary for the treatment of chronic pain of peripheral nerve origin. This change, effective July 31, 2025, marks a critical milestone in Nalu's mission to expand access to safe, innovative, drug-free alternatives for chronic pain relief. This policy shift moves Nalu from its prior classification of 'Investigational/Experimental' to 'Medically Necessary' for eligible patients—opening access to more than 22 million additional covered lives across the U.S. 'Aetna's recognition of Nalu as a medically necessary therapy is a powerful validation of our technology, clinical evidence, and commitment to patient outcomes,' said Tom West, Chief Executive Officer of Nalu Medical. 'We've built a robust body of clinical data demonstrating that Nalu PNS provides safe, effective, and durable relief for patients living with chronic, intractable pain, as well as healthcare economic data that demonstrates use of Nalu PNS results in significant cost savings. We're proud to see a leading payer like Aetna acknowledge that value, and we look forward to engaging with other health plans to expand access to this life-changing therapy.' Chronic peripheral nerve pain is often debilitating and unresponsive to conventional therapies, including long-term medication and surgery. The Nalu Neurostimulation System offers a minimally invasive, drug-free alternative that delivers precise electrical stimulation to targeted peripheral nerves, providing long-lasting relief while reducing the risks of opioid dependency and avoiding systemic side effects. About the Nalu Neurostimulation System The Nalu System consists of a fully featured, battery-free, miniaturized implantable pulse generator (IPG) 1 that is powered wirelessly by an externally worn Therapy Disc and controlled through a smartphone-based remote control app. Despite its small size, the Nalu micro-IPG™ delivers treatment capabilities similar to larger IPGs as well as advantages associated with advanced waveforms, extensive programming options, exceptional upgradability, and an expected service life of 18 years. The Nalu Neurostimulation System has been repeatedly recognized for its revolutionary technology, including being named as one of the world's top 100 new products by R&D Magazine in 2021 and ranking number 19 in the 2023 Deloitte Technology Fast 500. It is FDA-cleared for Spinal Cord Stimulation (SCS) and Peripheral Nerve Stimulation (PNS) indications. To learn more, visit About Nalu Medical, Inc. Nalu is a Carlsbad, California-based medical technology company focused on developing and commercializing innovative and minimally invasive solutions for patients with chronic neuropathic pain. The Nalu Neurostimulation System delivers gentle electrical pulses to the nervous system to modulate pain signals before they get to the brain. The Nalu Neurostimulation System was designed to address major unmet needs in the treatment of chronic neuropathic pain and provide a differentiated value proposition for patients and physicians. [1] Data on file, Nalu Medical, Inc. 2025.
Malaysian Reserve
a day ago
- Business
- Malaysian Reserve
2026 Medicare Physician Fee Schedule Rates Set for Scalp Cooling CPT Codes
SAN DIEGO, July 15, 2025 /PRNewswire/ — Cooler Heads, a health tech company dedicated to making scalp cooling more accessible and affordable for people undergoing chemotherapy, celebrates a major milestone in the effort to expand access to their hair-preserving treatment. The Centers for Medicare & Medicaid Services (CMS) has released its 2026 Medicare Physician Fee Schedule (MPFS) Proposed Rule, which includes three new Category I CPT® codes for mechanical scalp cooling, each assigned a proposed payment rate. This is the first time scalp cooling has been included in the Medicare Physician Fee Schedule, marking a critical step forward in establishing consistent reimbursement. 'This decision is important for patients suffering from hair loss, a devastating and visible side effect of chemotherapy,' said Kate Dilligan, Founder and CEO of Cooler Heads. 'These new codes and proposed rates are a positive step towards helping all patients undergoing treatment for solid tumor cancers preserve their identity during treatment.' CMS has proposed payment rates for three new CPT® codes related to mechanical scalp cooling. The first code, covering the initial fitting of the scalp cooling cap and patient education, would be reimbursed at $1,701. The second code, for the pre-infusion cooling period, is proposed at $10 per treatment. The third code, covering the post-infusion cooling period in 30-minute increments, would be reimbursed at $6 per unit. The new codes do not apply to manual cold caps, highlighting the importance of FDA-cleared mechanical scalp cooling systems like Amma™. This decision also sets a precedent for private insurers to develop their own coverage policies, increasing the likelihood of broader access to patients. After the public comment period concludes on September 12, 2025, and any subsequent updates are made, CMS is expected to release the Final Rule in November 2025. The revised Medicare Physician Fee Schedule (MPFS) rates and updated CPT codes will take effect on January 1, 2026. This timeline presents an exciting opportunity for Cooler Heads to collaborate with health systems. Contact:press@ About Cooler Heads: Cooler Heads, based in San Diego, provides evidence-based products, content, and services that cancer patients need to manage the challenging side effects of treatment. Founded by a cancer survivor, Cooler Heads is driven by the mission to reduce the physical and emotional toll of cancer treatment, offering tools like Amma to improve the quality of life for patients.
Business Wire
2 days ago
- Business
- Business Wire
Elucid's PlaqueIQ™ Image Analysis Software Included in EviCore Coverage Guidelines
BOSTON--(BUSINESS WIRE)-- Elucid, an AI medical technology company focused on providing physicians with a more precise view of atherosclerosis to drive patient-specific therapeutic decisions, today announced that EviCore, a radiology benefit manager, has updated its cardiac imaging guidelines to include coverage of coronary computed tomography angiography (CTA) plaque quantification (see pages 82-24), effective October 1, 2025. EviCore's updated coverage guidelines for CPT Codes 0623T-0624T could extend non-invasive plaque analysis to more individuals and help physicians gain a clearer understanding of each patient's coronary plaque. Elucid's flagship PlaqueIQ™ coronary plaque assessment technology falls within the coverage guidelines. PlaqueIQ delivers automated quantification and classification of plaque morphology, and is uniquely capable of identifying and quantifying lipid-rich necrotic core, the plaque type most strongly associated with cardiovascular risk. Share PlaqueIQ is the first and only FDA-cleared, non-invasive plaque analysis based on objective histology. PlaqueIQ delivers automated quantification and classification of plaque morphology, and is uniquely capable of identifying and quantifying lipid-rich necrotic core, the plaque type most strongly associated with cardiovascular risk. The software is designed to help physicians prioritize and personalize treatment based on actual coronary artery disease, rather than population-based risk. This technology supports physicians in evaluating patients' risk of future cardiac events, such as heart attack and stroke, and enables the development of personalized care pathways informed by each patient's individual plaque characteristics. 'EviCore's updated coverage guidelines demonstrate the increased understanding of the value of non-invasive coronary plaque analysis using Elucid PlaqueIQ,' said Elucid CEO Kelley Huang, PhD. 'This important milestone is one more step towards our vision of a future where cardiac care is personalized patient care as opposed to risk factor and population-based care.' EviCore's updated commercial coverage guidelines follow a new CMS rule that went into effect January 1, 2025, which doubled the amount paid to hospitals and outpatient clinics who perform cardiac CT scans from $175 to $357.13. This has allowed more hospitals, particularly those in non-urban areas, to be able to offer this service, reducing disparities in care. In late 2024, five of the seven Medicare Administrative Contractors (MACs) issued decisions to extend coverage of Elucid's PlaqueIQ AI-enabled quantitative coronary plaque analysis software, making it available to over 70 percent of eligible Medicare patients across the United States. Elucid will showcase the importance of plaque morphology quantification and classification at the lesion level and why morphology based on histology is the gold standard for plaque characterization at the 20 th Annual Meeting of the Society of Cardiovascular Computed Tomography (SCCT 2025), in Montréal from July 17-20, 2025. About Elucid Elucid is a Boston-based AI medical technology company dedicated to developing technology designed to provide physicians with a more precise view of atherosclerosis (coronary plaque buildup), the root cause of cardiovascular disease. The company's PlaqueIQ™ image analysis software is designed to help physicians prioritize and personalize treatment based on actual disease, rather than population-based risk of disease. PlaqueIQ includes the only FDA-cleared computed tomography angiography (CTA) algorithm that objectively quantifies plaque morphology validated against ground truth histology, the gold standard for characterization of plaque, as indicated by renowned pathologists. PlaqueIQ equips physicians with critical information regarding the type and amount of plaque in arteries that can lead to heart attack and stroke. Elucid is also pursuing an indication for FFR CT, derived from its plaque algorithm, to help identify coronary blockages and the extent of ischemia non-invasively. For more information, visit
Business Wire
2 days ago
- Business
- Business Wire
RenovoRx to Host Second Quarter 2025 Financial Results and Business Highlights Conference Call on August 14 th at 4:30 p.m. ET
MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)-- RenovoRx, Inc. ('RenovoRx' or the 'Company') (Nasdaq: RNXT), a life sciences company developing innovative targeted oncology therapies and commercializing RenovoCath ®, a novel, FDA-cleared drug-delivery device, today announced it will host its second quarter 2025 financial results and business highlights conference call on August 14, 2025, at 4:30 p.m. ET. Additional details will be available in the Investor Relations section of the Company's website at On the call, RenovoRx management is expected to discuss the latest developments and achievements for the Company's ongoing RenovoCath device commercialization efforts and for the Company's pivotal Phase III TIGeR-PaC trial in locally advanced pancreatic cancer (LAPC). For interested individuals unable to join the conference call, a dial-in replay will be available until August 28, 2025, and can be accessed by dialing 1-844-512-2921 (U.S. Toll Free) or 1-412-317-6671 (International) and entering replay pin number 13754672. About RenovoRx, Inc. RenovoRx, Inc. (Nasdaq: RNXT) is a life sciences company developing innovative targeted oncology therapies and commercializing RenovoCath ®, a novel, U.S. Food and Drug Administration (FDA)-cleared local drug-delivery device, targeting high unmet medical needs. RenovoRx's patented Trans-Arterial Micro-Perfusion (TAMP™) therapy platform is designed for targeted therapeutic delivery across the arterial wall near the tumor site to bathe the target tumor, while potentially minimizing a therapy's toxicities versus systemic intravenous therapy. RenovoRx's novel approach to targeted treatment offers the potential for increased safety, tolerance, and improved efficacy, and its mission is to transform the lives of cancer patients by providing innovative solutions to enable targeted delivery of diagnostic and therapeutic agents. In addition to the RenovoCath device, RenovoRx is also evaluating its novel drug-device combination oncology product candidate (intra-arterial gemcitabine, known as IAG) in the ongoing Phase III TIGeR-PaC trial. IAG is being evaluated by the Center for Drug Evaluation and Research (the drug division of the FDA) under a U.S. investigational new drug application that is regulated by the FDA's 21 CFR 312 pathway. IAG utilizes RenovoCath, the Company's FDA-cleared drug-delivery device, indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. The combination product candidate, which is enabled by the RenovoCath device, is currently under investigation and has not been approved for commercial sale. RenovoCath with gemcitabine received Orphan Drug Designation for pancreatic cancer and bile duct cancer, which provides seven years of market exclusivity upon new drug application approval by the FDA. RenovoRx is also engaged in implementing commercialization strategies utilizing its TAMP technology and FDA-cleared RenovoCath as a stand-alone device. In December 2024, RenovoRx announced the receipt of its first commercial purchase orders for RenovoCath devices. Additionally, several of these customers have already initiated repeat orders in parallel to RenovoRx expanding the number of medical institutions initiating new RenovoCath orders, including several esteemed, high-volume National Cancer Institute-designated centers. To meet and satisfy the anticipated demand, RenovoRx will continue to actively explore further revenue-generating activity, either on its own or in tandem with a medical device commercial partner. For more information, visit Follow RenovoRx on Facebook, LinkedIn, and X. Cautionary Note Regarding Forward-Looking Statements This press release, the conference call referred to herein, and statements of the Company's management made in connection therewith contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, and Section 21E of the Securities Exchange Act of 1934, including but not limited to statements regarding (i) our pre-clinical and clinical trials and studies, including the overall timing and timing for additional interim data readouts for our ongoing TIGeR-PaC Phase III clinical trial study in LAPC, (ii) the potential of RenovoCath® or TAMP™ as standalone commercial products, our anticipated timing for revenue generation from RenovoCath sales, and our commercialization plans in general, (iii) the potential for our product candidates to treat or provide clinically meaningful outcomes for certain medical conditions or diseases and (iv) our efforts to explore commercialization strategies utilizing our TAMP technology. Statements that are not purely historical are forward-looking statements. The forward-looking statements contained herein are based upon our current expectations and beliefs regarding future events, many of which, by their nature, are inherently uncertain, outside of our control, and involve assumptions that may never materialize or may prove to be incorrect. These may include estimates, projections, and statements relating to our research and development plans, commercial plans, intellectual property development, clinical trials, our therapy platform, business plans, financing plans, objectives, and expected operating results, which are based on current expectations and assumptions that are subject to significant known and unknown risks and uncertainties that may cause actual results to differ materially and adversely from those expressed or implied by these forward-looking statements. These statements may be identified using words such as 'may,' 'expects,' 'plans,' 'aims,' 'anticipates,' 'believes,' 'forecasts,' 'estimates,' 'intends,' and 'potential,' or the negative of these terms or other comparable terminology regarding RenovoRx's expectations strategy, plans, or intentions, although not all forward-looking statements contain these words. These forward-looking statements are subject to a number of risks, uncertainties, and assumptions that could cause actual events to differ materially from those projected or indicated by such statements, including, among other things: (i) the risk that our execution of our commercial strategy for RenovoCath or our TAMP technology may not lead to viable or repeating revenue generating operations, (ii) circumstances which would adversely impact our ability to efficiently utilize our cash resources on hand or raise additional funding, (iii) the timing of the initiation, progress and potential results (including the results of interim analyses) of TIGeR-PaC and any other preclinical studies, clinical trials, and our research programs, (iv) the possibility that interim results may not be predictive of the outcome of our clinical trials, which may not demonstrate sufficient safety and efficacy to support regulatory approval of our product candidate, (v) that the applicable regulatory authorities may disagree with our interpretation of the data, research and clinical development plans and timelines, and the regulatory process for our product candidates, (vi) future potential regulatory milestones for our product candidates, including those related to current and planned clinical studies, (vii) our ability to use and expand our therapy platform to build a pipeline of product candidates, (viii) our ability to advance product candidates into, and successfully complete, clinical trials, (ix) the timing or likelihood of regulatory filings and approvals, (x) our estimates of the number of patients who suffer from the diseases we are targeting and the number of patients that may enroll in our clinical trials, (xi) the commercialization potential of our product candidates, if approved, (xii) our ability and the potential to successfully manufacture and supply our product candidates for clinical trials and for commercial use, if approved, (xiii) future strategic arrangements and/or collaborations and the potential benefits of such arrangements, (xiv) our estimates regarding expenses, future revenue, capital requirements, and needs for additional financing, and our ability to obtain additional capital, (xv) the sufficiency of our existing cash and cash equivalents to fund our future operating expenses and capital expenditure requirements, (xvi) our ability to retain the continued service of our key personnel and to identify, and hire and retain additional qualified personnel, (xvii) the implementation of our strategic plans for our business and product candidates, (xviii) the scope of protection we are able to establish and maintain for intellectual property rights, including our therapy platform, product candidates, and research programs, (xix) our ability to contract with third-party suppliers and manufacturers and their ability to perform adequately, (xx) the pricing, coverage and reimbursement of our product candidates, if approved, and (xxi) developments relating to our competitors and our industry, including competing product candidates and therapies. Information regarding the foregoing and additional risks may be found in the section entitled 'Risk Factors' in documents that we file from time to time with the Securities and Exchange Commission. Forward-looking statements included herein are made as of the date hereof, and RenovoRx does not undertake any obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as required by law.
Yahoo
2 days ago
- Business
- Yahoo
Firefly Inks Latest Commercial Agreement for Use of its FDA-Cleared BNA™ Platform in Groundbreaking Precision Neuroscience Research
– Institute of Human Genetics at Heidelberg University Hospital ongoing EEG biomarker study on 15q13.3 CNVs – – Collaboration aims to uncover novel insights into the brain's functional architecture in rare genetic conditions – – Building and growing a license business is an increasingly important pillar of Firefly's commercial strategy – KENMORE, N.Y., July 14, 2025 (GLOBE NEWSWIRE) -- Firefly Neuroscience, Inc. ('Firefly' or the 'Company') (NASDAQ: AIFF), an Artificial Intelligence ('AI') company developing innovative solutions that improve brain health outcomes for patients with neurological and mental disorders, is pleased to highlight its ongoing collaboration with Prof. Dr. med. Christian Schaaf, Director of the Institute of Human Genetics at Heidelberg University Hospital and Chairman of Human Genetics at the Medical Faculty of Heidelberg University, on a groundbreaking study investigating the neurophysiological impact of 15q13.3 copy number variants ('CNVs'). This engagement builds on prior work between Firefly and Prof. Schaaf, including a joint publication on CHRNA7-related phenotypes.1 The current study leverages Firefly's FDA-cleared technology to analyze Electroencephalograms ('EEG') data from 30 subjects — 15 with deletions and 15 with duplications of the 15q13.3 chromosomal region. Study subjects undergo resting state and two cognitive paradigms running automatically through Firefly's BNA platform. The study is scheduled to run through 2026, with Firefly commercially engaged to provide EEG systems, training, and full analytic support, including the comparison to its proprietary, FDA-cleared normative Resting and Event-Related Potential Cognitive tasks database. The study aims to: Identify electrophysiological biomarkers associated with 15q13.3 CNVs; Characterize neurocognitive profiles linked to deletions vs. duplications; and Support future diagnostic and therapeutic strategies for neurodevelopmental disorders. 'This collaboration reflects our shared commitment to advancing precision neuroscience,' said Gil Issachar, Chief Technology Officer of Firefly. 'By combining Heidelberg's clinical expertise with our proprietary technology, we aim to uncover novel insights into the brain's functional architecture in rare genetic conditions. But our mission goes well beyond any single study — deepening our understanding of cognitive disorders, both common and rare, is essential to transforming how we diagnose, monitor, and treat these conditions. Every insight we gain from rare genetic variants like 15q13.3 helps illuminate the broader landscape of neurodevelopmental and neuropsychiatric disorders. We believe that by decoding the brain's electrical language, we can bridge the gap between genotype and phenotype, and ultimately bring more personalized, effective care to patients worldwide.' Greg Lipschitz, Chief Executive Officer of Firefly, said, 'As pharma and medtech organizations increasingly look to leverage the use of objective measures of brain activity such as EEG across various stages of new product development, from ideation up to and including commercialization, there is growing industry awareness and adoption of our highly differentiated, AI-powered technology. We are truly honored that a world-renowned physician scientist, like Prof. Schaaf, is the latest to see the value of his institution licensing our technology, and we look forward to updating our stakeholders as this important research is completed.' Source 1 Stern T, Crutcher EH, McCarthy JM, Ali MA, Issachar G, Geva AB, Peremen Z, Schaaf CP. Brain Network Analysis of EEG Recordings Can Be Used to Assess Cognitive Function in Teenagers With 15q13.3 Microdeletion Syndrome. Front Neurosci. 2021 Jan 28;15:622329. doi: 10.3389/fnins.2021.622329. PMID: 33584189; PMCID: PMC7876406. About Firefly Firefly (NASDAQ: AIFF) is an Artificial Intelligence ('AI') company developing innovative solutions that improve brain health outcomes for patients with neurological and mental disorders. Firefly's FDA-510(k) cleared Brain Network Analytics (BNA™) technology revolutionizes diagnostic and treatment monitoring methods for conditions such as depression, dementia, anxiety disorders, concussions, and ADHD. Over the past 15 years, Firefly has built a comprehensive database of brain wave tests, securing patent protection, and achieving FDA clearance. The Company is now launching BNA™ commercially, targeting pharmaceutical companies engaged in drug research and clinical trials, as well as medical practitioners for clinical use. Brain Network Analytics was developed using artificial intelligence and machine learning on Firefly's extensive proprietary database of standardized, high-definition longitudinal electroencephalograms (EEGs) of over 17,000 patients representing twelve disorders, as well as clinically normal patients. BNA™, in conjunction with an FDA-cleared EEG/ERP system, can provide clinicians with comprehensive insights into brain function. These insights can enhance a clinician's ability to accurately diagnose mental and cognitive disorders and to evaluate what therapy and/or drug is best suited to optimize a patient's outcome. Please visit for more information. About Prof. Christian Schaaf Professor Schaaf is the Medical Director at Heidelberg University Hospital and Department Chair of the Institute of Human Genetics at the Heidelberg University in Germany. He studies the genetic causes of neurodevelopmental and neuropsychiatric disorders, including copy number variants of 15q13.3. His work led to the discovery of multiple new disease genes, and three disorders have been named after him: Schaaf-Yang syndrome, Bosch-Boonstra-Schaaf Optic Atrophy syndrome, and Marbach-Schaaf Neurodevelopmental syndrome. Professor Schaaf's groundbreaking work has been recognized with many awards, including the William K. Bowes Award for Medical Genetics by Partners Healthcare and Harvard Medical School and the inaugural Seldin-Smith Award for Pioneering Research by the American Society for Clinical Investigation. Forward-Looking Statements Certain statements in this press release may constitute 'forward-looking statements' for purposes of the federal securities laws concerning Firefly. These forward-looking statements include express or implied statements relating to Firefly's management teams' expectations, hopes, beliefs, intentions, or strategies regarding the future. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words 'anticipate,' 'believe,' 'contemplate,' 'continue,' 'could,' 'estimate,' 'expect,' 'intends,' 'may,' 'might,' 'plan,' 'possible,' 'potential,' 'predict,' 'project,' 'should,' 'will,' 'would' and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements are based on current expectations and beliefs concerning future developments and their potential effects. There can be no assurance that future developments affecting Firefly will be those that have been anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond Firefly's control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to those factors described under the heading 'Risk Factors' in the reports and other filings of Firefly with the Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should any of Firefly's assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. It is not possible to predict or identify all such risks. Forward-looking statements included in this press release only speak as of the date they are made, and Firefly does not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws. Investor & Media ContactStephen Kilmer(646)
