Latest news with #FDA-Approved
Business Wire
07-07-2025
- Health
- Business Wire
SoundHealth Launches Android App for Its FDA-Approved SONU Band
SAN FRANCISCO--(BUSINESS WIRE)-- SoundHealth, the medical technology company behind the SONU Band, has launched the first-ever medical-grade Android app capable of transforming a selfie into CT-accurate skeletal data for the treatment of rhinitis. The SONU Band is the world's first FDA De Novo authorized, AI-enabled wearable medical device that uses sound-based therapy to relieve moderate to severe nasal congestion and allergy symptoms at home and without the need for drugs or sprays. SoundHealth Launches Android App for Its FDA-Approved SONU Band Share Built to work seamlessly with the band, the app leverages proprietary AI to analyze 3D facial scans in conjunction with symptom data and CT imaging to deliver precise, therapeutic-grade treatments for sinus and allergy-related conditions. 'We are thrilled to bring the SONU Band to Android users now,' said Dr. Paramesh Gopi, founder and CEO of SoundHealth. 'Our Android app is a first of its kind, and this launch expands access to drug-free relief to millions of people suffering from allergies and sinus issues.' The SONU app scans the patient's face using a smartphone and creates a digital map of their sinuses, calculating their optimal resonant frequencies. Following the initial one-time scan, the patient simply places the SONU Band around their head, turns it on and the band delivers frequencies tailored to the patient. The band opens airways naturally to reduce congestion and promote easy breathing, without drugs or steroids. Providing relief in just 15 minutes, SONU is recommended by over 1,000 doctors and dentists across the country. SONU is the only FDA-approved device equivalent to or better than the leading nasal steroid spray, calming down symptoms of allergies, inflammation and congestion. It uses acoustic vibrational energy to provide personalized relief, reducing swelling, opening nasal passages and draining healthy mucus. Over 80 percent of SONU patients report improvement in their nasal symptoms, representing a new category of safe and rapid relief therapies for nasal congestion. The SONU Band also recently received FDA approval for pediatric use for children over 12 years of age, giving families a safe alternative to pharmaceuticals. SONU is convenient, user-friendly and pleasant to use for patients. For more information, please visit About SoundHealth SoundHealth is a medical technology company that harnesses the power of artificial intelligence and medical science to improve respiratory and mental health. The SoundHealth team consists of experienced medical professionals, data scientists and engineers who are passionate about improving healthcare. visit
Medscape
27-06-2025
- Health
- Medscape
New Guidance on the Use of Unproven Neurologic Therapeutics
A new position statement outlining guiding principles for navigating the use of unproven therapies for neurologic conditions that lack approval from the FDA or robust scientific evidence has been released by the American Academy of Neurology (AAN). The statement is intended to support informed conversations between clinicians, patients, and policymakers about emerging or unproven treatments. While it includes examples of such therapies, the document stops short of offering clinical recommendations. The use of emerging neurologic therapies not yet supported by science has been 'an ongoing concern,' with patients often asking providers about these therapies, the statement's lead author Larry B. Goldstein, MD, professor and chair of the Department of Neurology and associate dean for Clinical Research, University of Kentucky, Lexington, Kentucky, told Medscape Medical News. Developed in response to requests from AAN members seeking guidance on emerging therapeutics, the statement outlines guiding principles to support clinical and policy discussions. It was published online on June 25 in Neurology. Lack of FDA-Approved Options Many neurologic diseases have no available FDA-approved therapeutic options and no, or limited, evidence-based treatments. However, many potential treatments, both synthetic and naturally occurring, may be in varying stages of expert evaluation for neurologic conditions. Psychedelics have emerged as potential therapies for pain disorders such as cluster headache, as well as psychiatric conditions including major depression, posttraumatic stress disorder (PTSD), generalized anxiety, and substance use disorders. However, data on psychedelics' risks and benefits for these indications are limited. The AAN committee cites the example of midomafetamine combined with psychotherapy for the treatment of PTSD. Although this approach has generated interest, an FDA advisory committee recently recommended against its approval, citing significant methodological flaws in the supporting studies and advising the FDA to reject the Investigational New Drug Application. 'This illustrative example highlights the need for rigorous, placebo-controlled, double-blind trials to adequately test the effectiveness of these therapies while exhaustively documenting adverse events to characterize patient safety issues,' the statement's authors noted. The AAN supports the FDA-accelerated review of novel therapeutics for neurologic conditions 'when this process is appropriate,' said Goldstein. Off-Label Use The statement also addresses the expanded use of therapies beyond their original FDA-approved indications — for example, the off-label use of alteplase for thrombolysis in ischemic stroke patients treated 3-4.5 hours after they were last known to be well, as well as the use of tenecteplase in select cases of acute ischemic stroke. Goldstein noted that these examples reflect issues commonly encountered in hospitals nationwide. 'The AAN supports the off-label use of FDA-approved therapies in settings in which the high-quality evidence indicates that the benefit of the therapy outweighs the risks with shared decision-making between the patient and physician in the model of informed consent,' the statement authors noted. Another example is natalizumab, a humanized IgG4κ monoclonal antibody approved for the treatment of relapsing-remitting multiple sclerosis (MS). The drug was initially withdrawn from the market following reports of progressive multifocal leukoencephalopathy. However, it was later reintroduced, as some patients with MS have no alternative therapies to effectively manage their disease. Physician-patient discussions about unproven therapies might include situations where patients are considering their 'Right to Try.' Signed into law in 2018, the Right to Try Act allows individuals with a terminal illness who have tried all approved treatments and who are unable to participate in a clinical trial to receive an experimental treatment. The statement also addresses the issue of adverse events reported after FDA approval. For example, the statin cerivastatin was approved for cholesterol reduction but was withdrawn from clinical use following reports of deaths and hospitalizations. These cases, said Goldstein, illustrate the complexity of this issue. 'It's particularly challenging because healthcare providers must be constantly aware of new data that may become available as therapeutics enter general use after FDA approval,' said Goldstein. In cases where a therapy is approved but carries significant risks or an incomplete adverse event profile, the statement advises that the AAN should generally refrain from taking a definitive position until further review by the FDA is completed. Unproven 'Treatments' The authors also address the use of therapeutics with limited or no supporting data, many of which have been popularized on social media, to treat or prevent conditions such as dementia. Such use not only exposes patients to unknown risks but may also discourage them from pursuing evidence-based treatments or participating in clinical trials that could offer potential benefits, Goldstein noted. When seeing patients, healthcare providers should discuss potential participation in a relevant trial and ask more detailed questions about the use of unproven therapies, he said. 'Physicians should routinely not only confirm their patient's prescribed medications but also ask about any other substances they may be using. Some, including certain supplements, may have potential toxicities or interactions with prescribed medications.' Discussions between neurologists and patients about unproven therapies are becoming increasingly relevant. 'In the current climate of unfiltered, at times incorrect or misinterpreted information, having a trustworthy source of fact-based advice is critically important,' said Goldstein. 'The neurologist brings particular expertise and training related to neurological disorders and what is known about the risks and benefits of potential treatments to help inform patient decisions,' he added. The AAN policy statement offers 'a framework' to guide neurologists in their role as patient advocates, Goldstein added. Although it does not address specific treatments, it does provide a structure for conversations with patients, said Goldstein.
Time Business News
30-04-2025
- Health
- Time Business News
How Psychiatrists Determine If Spravato Treatment Is Right for You
Choosing the right path to healing isn't always straightforward—especially when it comes to managing treatment-resistant depression (TRD). For individuals who haven't found success with traditional antidepressants, Spravato (esketamine nasal spray) has become a groundbreaking option. But how do psychiatrists determine whether you're a candidate for Spravato? If you're considering Spravato in NYC, understanding the evaluation process can help you feel confident and prepared. In this article, we'll unpack how psychiatrists assess suitability for Spravato treatment, the criteria they use, and the steps involved to ensure you get the safest and most effective care. Before diving into the decision-making process, let's briefly revisit what Spravato is: Esketamine Nasal Spray : A fast-acting medication derived from ketamine, approved for adults with TRD and major depressive disorder (MDD) with suicidal ideation. : A fast-acting medication derived from ketamine, approved for adults with TRD and major depressive disorder (MDD) with suicidal ideation. FDA-Approved : Since 2019, offering new hope to those who haven't responded to other treatments. : Since 2019, offering new hope to those who haven't responded to other treatments. Administered at Certified Centers: Like many facilities offering Spravato in NYC, treatment must occur under medical supervision. Spravato works differently from traditional antidepressants by targeting the glutamate system to enhance brain plasticity and mood regulation. Psychiatrists begin with a full psychiatric evaluation, which includes: Mental Health History : Diagnoses, treatments, hospitalizations. : Diagnoses, treatments, hospitalizations. Medication History : Which antidepressants have been tried, for how long, and at what dosages. : Which antidepressants have been tried, for how long, and at what dosages. Current Symptoms : Depression severity, suicidal thoughts, functional impairments. : Depression severity, suicidal thoughts, functional impairments. Family History: Genetics can play a role in mental health treatment response. Clinics providing Spravato in NYC often use standardized diagnostic tools like the DSM-5 criteria to guide this process. Spravato is reserved for treatment-resistant cases. Psychiatrists must confirm that: You have tried at least two different antidepressants at therapeutic doses. You adhered to treatments for at least 6-8 weeks each time without sufficient improvement. Patients receiving Spravato in NYC are required to provide medical records or pharmacy histories to document previous treatment failures. Spravato is powerful—but not for everyone. Certain conditions can make it unsafe, so psychiatrists screen for: Cardiovascular issues (e.g., hypertension, aneurysms) (e.g., hypertension, aneurysms) Substance abuse (past or present) (past or present) Psychotic disorders (e.g., schizophrenia, schizoaffective disorder) (e.g., schizophrenia, schizoaffective disorder) Pregnancy and breastfeeding status Before beginning Spravato in NYC, a physical exam and lab work (blood pressure, liver function tests, etc.) are often required. Because Spravato has dissociative properties and some abuse potential, psychiatrists carefully assess your substance use history: Alcohol misuse Illicit drug use Prescription medication misuse For patients seeking Spravato in NYC, an open, honest discussion about substance use ensures safe and effective treatment planning. Psychiatrists also gauge: Coping skills Motivation for therapy Ability to participate in a structured treatment program Many centers offering Spravato in NYC integrate talk therapy into treatment because Spravato works best when combined with psychological support. Many insurers covering Spravato in NYC require: Documentation of antidepressant failures Prior authorization paperwork Ongoing progress reports Psychiatrists and clinic staff often help patients navigate these processes to minimize delays. Because you cannot drive after a Spravato session (due to possible sedation and dissociation), psychiatrists will ask about: A designated driver for each treatment day Emotional support at home Access to emergency help if needed Clinics administering Spravato in NYC sometimes require a 'treatment buddy' commitment for safety. Here's how decisions typically break down: ✅ Good Candidate: Diagnosed with TRD or MDD with suicidal ideation Failed multiple antidepressants No disqualifying medical conditions Engaged in therapy or willing to start Reliable support system ❌ Not Yet Ready: Active substance use disorder Uncontrolled physical health issues Untreated psychosis Refusal or inability to comply with post-treatment monitoring In short: eligibility for Spravato in NYC depends on readiness, safety, and clear medical need. Once you're approved, here's what you can expect: Induction Phase : Twice-weekly Spravato treatments for 4 weeks : Twice-weekly Spravato treatments for 4 weeks Maintenance Phase : Weekly or biweekly sessions based on progress : Weekly or biweekly sessions based on progress Observation Period : Mandatory 2-hour monitoring after each session : Mandatory 2-hour monitoring after each session Ongoing Psychiatric Check-Ins: Regular mood evaluations and side-effect monitoring Clinics offering Spravato in NYC create custom schedules to fit your needs while following REMS (Risk Evaluation and Mitigation Strategy) program protocols. Psychiatrists track: Symptom reduction via PHQ-9 or MADRS scores Side effects (e.g., dizziness, nausea, dissociation) Improvements in daily life functioning (e.g., work, relationships, hobbies) If no improvements are seen within 8–12 weeks, psychiatrists may adjust treatment plans or explore alternative options. After two months of integrated Spravato sessions and weekly therapy: Her PHQ-9 scores dropped by 60% - She returned to work full-time - She reported better sleep, higher energy, and restored hope Emma's story mirrors that of many who find renewed life through carefully selected Spravato treatment. Truth: Only those with treatment-resistant depression or acute suicidal ideation qualify. Truth: Esketamine (Spravato) is different from IV ketamine; many patients tolerate it better. Truth: Combining therapy with Spravato leads to stronger, longer-lasting outcomes. The decision to start Spravato isn't taken lightly. Psychiatrists use a thorough, patient-centered approach that evaluates your mental health history, physical health, support system, and readiness for deep healing. If you're exploring Spravato in NYC, trust that your psychiatric team is working to ensure this transformative treatment is safe, appropriate, and maximized for your success. TIME BUSINESS NEWS
Yahoo
07-04-2025
- Health
- Yahoo
Reunion Neuroscience Presents REKINDLE, a Phase 2 Clinical Trial Evaluating RE104 for the Treatment of Adjustment Disorder (AjD) in Cancer and Other Medical Illnesses at the Anxiety & Depression Association of America (ADAA) 2025 Conference
-- AjD is a Mental Health Condition Triggered By a Stressful Life Event; Particularly Common in People with Serious Medical Illness -- -- AjD Represents an Area of Significant Unmet Need; No FDA-Approved Therapies Currently Available -- -- Expansion of Clinical Development Program into AjD in Cancer and Other Medical Illnesses Reflects Broad Potential of RE104 to Revolutionize Mental Health Treatment -- -- Initiation of REKINDLE Phase 2 Trial Expected Mid-2025 -- MORRISTOWN, N.J., April 07, 2025 (GLOBE NEWSWIRE) -- Reunion Neuroscience Inc., a clinical-stage biopharmaceutical company committed to revolutionizing the treatment of underserved mental health disorders through the advancement of next-generation psychedelic-inspired therapeutic solutions, presented the study design for the REKINDLE Phase 2 clinical trial, which will evaluate the safety and efficacy of RE104 for the treatment of adjustment disorder (AjD) in patients with cancer and other medical illnesses. The study design was presented in a poster session at the Anxiety & Depression Association of America (ADAA) 2025 Conference, held April 3-5, 2025, in Las Vegas, NV. A copy of the poster is available at AjD is a mental health condition defined as a disproportionate reaction to a stressful life event or change, which impacts the ability to function and is characterized by depression, anxiety and/or other behavioral and mood disturbances. Serious medical illnesses are known to be a key precipitant of AjD; it is estimated that approximately 500,000 people in the United States are diagnosed with AjD each year following a medical or health-related stressor. Depressive and anxiety symptoms in medically ill patients with AjD can be associated with poorer medical outcomes, treatment compliance and quality of life as well as increased health care utilization. Current treatments for AjD are not consistently effective, and there are no therapies presently approved by the U.S. Food and Drug Administration (FDA) for its treatment. With RE104, the only psychedelic therapeutic in advanced clinical development for an AjD indication in the United States, Reunion Neuroscience aims to offer patients an effective, safe and fast-acting psychotropic medication to relieve distress and dysfunction in patients with AjD. 'The unveiling of our REKINDLE Phase 2 clinical trial marks an important step in our efforts to expand the clinical development of RE104. Similar to postpartum depression (PPD), where we are currently evaluating RE104 in the RECONNECT Phase 2 clinical trial, AjD is a devastating psychiatric condition that meaningfully impacts quality of life and is often marked by depression and/or anxiety,' said Greg Mayes, President and Chief Executive Officer of Reunion Neuroscience. 'With RE104, we believe we can leverage the power of 4-OH-DIPT to offer a rapid onset, short duration psychedelic experience that delivers immediate, substantial and sustained improvement to patients with AjD. We look forward to initiating REKINDLE in mid-2025 as we pursue our mission of transforming the care and treatment of mental health disorders through the advancement of next-generation psychedelic-inspired solutions.' The REKINDLE Phase 2 clinical trial is a randomized, double-blind, parallel-group, dose-controlled clinical trial evaluating the safety and efficacy of RE104 for the treatment of AjD in adult patients with cancer and other medical illnesses. The primary endpoint of the trial is the change in total Montgomery-Asberg Depression Rating Scale (MADRS) score, a clinician rated scale measuring depression severity from baseline, at Day 14. A key secondary endpoint of the trial is the change in Hamilton Anxiety Scale (HAM-A), a clinician rated scale measuring anxiety severity from baseline, at Day 14. The study will also assess safety and tolerability of RE104. 'AjD represents a significant unmet need -- it is debilitating both in its own right, and in the impact it can have on overall health outcomes in patients suffering from medical illnesses,' said Mark Pollack, M.D., Chief Medical Officer of Reunion Neuroscience. 'The importance of treating mental health in parallel with serious diseases is becoming increasingly well-recognized, and we are eager to introduce RE104 as an innovative solution, which can potentially rescue patients from the impact depression and anxiety may otherwise have on their physical well-being and recovery. As we approach mid-2025, we look forward to announcing initial data for RE104 in PPD, a disease that manifests much like AjD, and to initiating the REKINDLE trial.' Reunion Neuroscience is also evaluating RE104 in RECONNECT (NCT06342310), a multicenter, randomized, double-blind, active dose-controlled Phase 2 clinical trial evaluating the safety and efficacy of a single subcutaneous dose of RE104 in adult female patients with moderate-to-severe PPD. Initial data from RECONNECT are expected in mid-2025. To learn more about the study and eligibility for enrollment, please visit About RE104The Company's lead product candidate, RE104, is a proprietary, potential best-in-class, patented prodrug of 4-OH-DiPT. Reunion designed RE104 to deliver a short duration psychedelic experience compared to longer duration psychedelics like psilocybin. In a Phase 1 clinical trial, RE104 produced a psychedelic state similar in intensity and quality to psilocybin, but lasting only about half the time (3-4 hours), while demonstrating a similar, favorable safety profile. RE104 is currently being evaluated in the RECONNECT Phase 2 (NCT06342310) clinical trial, a multicenter, randomized, double-blind, active dose-controlled clinical trial in moderate-to-severe postpartum depression (PPD) patients. Initial data from RECONNECT are expected in mid-2025. To learn more about the study and eligibility for enrollment, please visit Reunion plans to initiate the REKINDLE Phase 2 clinical trial, a randomized, double-blind, parallel-group, dose-controlled trial in AjD in cancer and other medical illnesses in mid-2025. About Reunion Neuroscience Neuroscience is a clinical-stage biopharmaceutical company committed to revolutionizing the treatment of underserved mental health disorders through the advancement of next-generation psychedelic therapeutic solutions. In 2023, Reunion Neuroscience became a private company and in 2024, the Company completed a Series A financing co-led by MPM BioImpact and Novo Holdings. Reunion is actively investigating the use of its lead product candidate, RE104, in postpartum depression and adjustment disorder, as well as in additional neuropsychiatric indications where there remains a significant unmet need that is not addressed by the current standard of care. For more information about the company, visit IR Inquiries:Hannah DeresiewiczPrecision PR Inquiries:Ashley Murphy Precision in to access your portfolio
Associated Press
19-03-2025
- Health
- Associated Press
Gloss Medical Aesthetics & Laser Pioneers Safe & Effective Laser Hair Removal for All Skin Tones with FDA-Approved Technology
Baltimore, USA - Gloss Medical Aesthetics & Laser, a premier provider of advanced beauty and skincare treatments, is proud to reaffirm its commitment to inclusive beauty with FDA-approved laser technology. Specializing in safe and effective laser hair removal for a diverse range of skin tones, including darker skin, Gloss Medical Aesthetics & Laser is dedicated to providing exceptional results for all clients. With the evolution of aesthetic technology, many individuals with darker skin tones have struggled to find safe and effective laser hair removal treatments. Traditional laser devices were often limited in their ability to treat melanin-rich skin without the risk of burns or hyperpigmentation. However, Gloss Medical Aesthetics & Laser is changing the game by investing in cutting-edge FDA-approved technology specifically designed to cater to all skin types. Advanced FDA-Approved Laser Technology for All Skin Tones At Gloss Medical Aesthetics & Laser, patient safety and satisfaction are top priorities. The clinic utilizes state-of-the-art laser hair removal systems that are tailored to deliver optimal results with minimal discomfort. Their technology effectively targets hair follicles without causing damage to the surrounding skin, making it a safe and reliable choice for individuals of all ethnic backgrounds. 'Our goal is to make advanced skincare treatments accessible to everyone, regardless of skin tone,' said a representative of Gloss Medical Aesthetics & Laser. 'We understand the concerns that many individuals with darker skin have when considering laser hair removal, and we are proud to offer a solution that is both safe and effective.' The Benefits of Laser Hair Removal at Gloss Medical Aesthetics & Laser: Safe for All Skin Types – The clinic's FDA-approved lasers are designed to work effectively on all skin tones, including melanin-rich skin. Long-Lasting Results – Laser hair removal significantly reduces hair growth over time, offering a convenient and long-term solution to unwanted hair. Comfortable Experience – The advanced cooling technology incorporated into the laser systems helps to minimize discomfort during treatments. Experienced Professionals – The team at Gloss Medical Aesthetics & Laser consists of highly trained and certified professionals who are experts in treating a variety of skin tones. A Commitment to Inclusive Beauty Gloss Medical Aesthetics & Laser believes that beauty treatments should be accessible to everyone. By prioritizing inclusivity in their services, they continue to break barriers in the aesthetics industry, ensuring that clients from all backgrounds feel welcomed and confident in their treatment choices. Their team provides personalized consultations to assess each client's unique skin type and hair removal needs, ensuring customized treatment plans that deliver optimal results. The clinic's focus on safety, efficacy, and inclusivity has positioned it as a trusted name in Baltimore and beyond. Whether clients are looking to eliminate unwanted hair, achieve smoother skin, or enhance their overall confidence, Gloss Medical Aesthetics & Laser remains the go-to destination for top-tier laser hair removal services. Book a Consultation Today For those interested in learning more about laser hair removal and its benefits, Gloss Medical Aesthetics & Laser offers complimentary consultations to discuss individual treatment goals. The clinic encourages prospective clients to take the first step towards smoother, hair-free skin by scheduling an appointment today. For more information, visit or contact Gloss Medical Aesthetics & Laser at 443-998-9258. About Gloss Medical Aesthetics & Laser: Gloss Medical Aesthetics & Laser is a leading provider of aesthetic treatments in Baltimore, USA. Offering a range of advanced skincare and beauty services, the clinic is committed to delivering safe, effective, and inclusive treatments tailored to the needs of all clients. With a focus on cutting-edge technology and exceptional patient care, Gloss Medical Aesthetics & Laser continues to set the standard in the medical aesthetics industry. Media Contact
