Latest news with #FDA-cleared
Business Wire
2 days ago
- Business
- Business Wire
Qure.ai Recognized Among TIME's 100 Most Influential Companies of 2025
NEW YORK--(BUSINESS WIRE)-- the world's most widely adopted digital health innovator, has been named to TIME's 2025 TIME100 Most Influential Companies list. Now in its fifth year, the TIME100 list highlights companies making an extraordinary global impact through innovation, ambition, and measurable success. TIME's editorial spotlighted work in advancing diagnostic equity through AI, stating: 'Trained on one of the world's largest data sets, algorithms are as accurate as a radiologist, according to the company, providing crucial insights in rural or developing areas where specialists may not be available. tools have now been deployed in more than 100 countries, and the company has 18 FDA clearances—the greatest number for lung cancer AI in the U.S.—including three new approvals in 2024.' was selected alongside iconic and dynamic brands such as Abbott, Midi Health, Vertex Pharmaceuticals, Function Health, Gilead, CRISPR Therapeutics, NBBJ, and Northwell Health, and is featured in the Pioneer category among health tech AI firms on the 2025 list. Speaking on the recognition, Prashant Warier, CEO and Founder said, 'To be named among TIME's 100 Most Influential Companies is an acknowledgment of a simple but urgent belief: that access to timely, high-quality diagnostics should not depend on where you live. This honor reflects the dedication of our teams and partners across continents, working to close the gap between innovation and impact. This recognition pushes us to keep advancing that future, where care begins long before crisis.' This milestone recognition follows a pivotal year for marked by accelerated momentum in the United States. With over 18 FDA-cleared findings and the launch of its Lung Cancer Care Continuum, a portfolio of AI solutions to detect, measure, and manage lung nodules; now offers an end-to-end suite that supports earlier lung cancer diagnosis across diverse care settings. Backed by a strategic Series D round led by global investors including Lightspeed, 360 One Asset, and the Merck Global Health Innovation Fund, the company is scaling its commercial and clinical impact worldwide. On the global front, continues to lead in innovation for low- and middle-income countries, drawing on its deep experience in TB surveillance at scale. Its newest offering, Aira, a multi-disease clinical AI co-pilot, was launched at the World Health Assembly in Geneva to support care coordination in resource-constrained settings. To compile this year's TIME100 list, TIME's editors evaluated nominees across sectors based on impact, innovation, ambition, and success, after polling its global network of journalists and outside experts. The final list spotlights 105 companies helping chart a path forward for the world. See the full list here: About is a health tech company that uses deep learning and Artificial Intelligence (AI) to make healthcare more accessible and equitable for patients worldwide. Our solutions power the efficient identification and management of Tuberculosis (TB), Lung Cancer and Neurocritical conditions to support clinicians and propel developments in the pharmaceutical and medical device industries. We empower healthcare by helping to identify conditions fast, prioritize treatment planning and ultimately improve quality of patient life.
Yahoo
3 days ago
- Business
- Yahoo
Sequel Named as the Official Tampon Partner of the Indiana Fever
Free Sequel products to be available throughout Gainbridge Fieldhouse INDIANAPOLIS & SAN FRANCISCO, June 26, 2025--(BUSINESS WIRE)--Sequel has been named as the Official Tampon Partner of the Indiana Fever, it was announced today. As part of the partnership, Sequel products will be available to both Fever players and fans, with complimentary Spiral Tampons available in the team's locker room and throughout Gainbridge Fieldhouse restrooms. "We are very excited to team up with Sequel, a women-founded and led company that is prioritizing the needs of women athletes," said Indiana Fever COO and General Manager Amber Cox. "We are proud to offer free Sequel products to our Fever family, both on the court and off, so they can enjoy the game of basketball with comfort and confidence." "Partnering with the Fever means being able to work with the best organization, athletes, and fans in the world right now," said Sequel co-founder and Chief Executive Officer, Greta Meyer. "Whether you're on the court or cheering on in the stands, Sequel's goal has always been to be a reliable and trustworthy option, and with this partnership we're getting the chance to do that on one of the biggest stages in women's sports." Co-founded by former athletes and engineers Amanda Calabrese and Greta Meyer, Sequel tampons are designed with the athlete in mind. Looking for a period product that fit their active lifestyle and provided better leak protection, the Stanford Cardinal alumnae created their own product, which features helical grooves designed for even absorption. The game-changing product may be familiar to Fever fans, with guard Lexie Hull also serving as an ambassador for the brand. About the Indiana Fever: The Indiana Fever were announced as an expansion franchise in the Women's National Basketball Association (WNBA) in June 1999 and began play during the 2000 season. In 2012, led by Hall of Famer Tamika Catchings, the team won its first WNBA Championship. Today, the team is headlined by some of the league's biggest stars including back-to-back No. 1 overall draft picks Aliyah Boston (2023) and Caitlin Clark (2024), as well as veteran leaders such as Kelsey Mitchell and Natasha Howard. This season, over the weekend of July 18-19, the Fever will host the 2025 WNBA All-Star Game at Gainbridge Fieldhouse. More information can be found here. To learn more about the Fever, purchase tickets or join the season ticket waitlist, visit The team can also be followed across all social media platforms including YouTube, Instagram, Facebook, X, and TikTok. About Sequel: Sequel is redefining a critical and stagnant category in women's health, starting with the first reengineered tampon in 80 years. Founded by Stanford product designers and former high-level athletes, the FDA-cleared Sequel Spiral Tampon uses a patented helical design to help prevent leakage and support comfort on and off the field. Sequel is partnering with the best in the sports world to bring the Spiral Tampon to athletes and women everywhere, including Stanford Athletics, Athletes Unlimited, Unrivaled Basketball, DC United, DC Power, and the Indiana Fever. Sequel is backed by top investors in tech, impact, and sports, such as Pear VC, MaC Venture Capital, Cyan Banister and Assia Grazioli. To learn more and try Sequel visit or find us on socials @trysequel on Instagram and TikTok. View source version on Contacts Media Contact: Jackie Maynard, Indiana Fever (jmaynard@ Calabrese, Sequel (amanda@ 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
3 days ago
- Business
- Business Wire
Sequel Named as the Official Tampon Partner of the Indiana Fever
INDIANAPOLIS & SAN FRANCISCO--(BUSINESS WIRE)-- Sequel has been named as the Official Tampon Partner of the Indiana Fever, it was announced today. As part of the partnership, Sequel products will be available to both Fever players and fans, with complimentary Spiral Tampons available in the team's locker room and throughout Gainbridge Fieldhouse restrooms. 'We are very excited to team up with Sequel, a women-founded and led company that is prioritizing the needs of women athletes,' said Indiana Fever COO and General Manager Amber Cox. 'We are proud to offer free Sequel products to our Fever family, both on the court and off, so they can enjoy the game of basketball with comfort and confidence.' 'Partnering with the Fever means being able to work with the best organization, athletes, and fans in the world right now,' said Sequel co-founder and Chief Executive Officer, Greta Meyer. 'Whether you're on the court or cheering on in the stands, Sequel's goal has always been to be a reliable and trustworthy option, and with this partnership we're getting the chance to do that on one of the biggest stages in women's sports.' Co-founded by former athletes and engineers Amanda Calabrese and Greta Meyer, Sequel tampons are designed with the athlete in mind. Looking for a period product that fit their active lifestyle and provided better leak protection, the Stanford Cardinal alumnae created their own product, which features helical grooves designed for even absorption. The game-changing product may be familiar to Fever fans, with guard Lexie Hull also serving as an ambassador for the brand. About the Indiana Fever: The Indiana Fever were announced as an expansion franchise in the Women's National Basketball Association (WNBA) in June 1999 and began play during the 2000 season. In 2012, led by Hall of Famer Tamika Catchings, the team won its first WNBA Championship. Today, the team is headlined by some of the league's biggest stars including back-to-back No. 1 overall draft picks Aliyah Boston (2023) and Caitlin Clark (2024), as well as veteran leaders such as Kelsey Mitchell and Natasha Howard. This season, over the weekend of July 18-19, the Fever will host the 2025 WNBA All-Star Game at Gainbridge Fieldhouse. More information can be found here. To learn more about the Fever, purchase tickets or join the season ticket waitlist, visit The team can also be followed across all social media platforms including YouTube, Instagram, Facebook, X, and TikTok. About Sequel: Sequel is redefining a critical and stagnant category in women's health, starting with the first reengineered tampon in 80 years. Founded by Stanford product designers and former high-level athletes, the FDA-cleared Sequel Spiral Tampon uses a patented helical design to help prevent leakage and support comfort on and off the field. Sequel is partnering with the best in the sports world to bring the Spiral Tampon to athletes and women everywhere, including Stanford Athletics, Athletes Unlimited, Unrivaled Basketball, DC United, DC Power, and the Indiana Fever. Sequel is backed by top investors in tech, impact, and sports, such as Pear VC, MaC Venture Capital, Cyan Banister and Assia Grazioli. To learn more and try Sequel visit or find us on socials @trysequel on Instagram and TikTok.
Business Wire
3 days ago
- Business
- Business Wire
Alto Neuroscience Identifies Biomarker and Reports Positive Pharmacodynamic Results from Exploratory Phase 2 Proof-of-Concept Trial of ALTO-203
MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)--Alto Neuroscience, Inc. ('Alto') (NYSE: ANRO) a clinical-stage biopharmaceutical company focused on the development of novel precision medicines for neuropsychiatric disorders, today announced the identification of a patient selection biomarker and positive pharmacodynamic results from its exploratory Phase 2 proof-of-concept (POC) trial of ALTO-203 in major depressive disorder (MDD) patients with elevated levels of anhedonia. ALTO-203 is a novel, oral, histamine H3 inverse agonist, designed to modulate circuits underlying cognition, wakefulness, and alertness. The profile exhibited by ALTO-203 in the exploratory POC trial demonstrated clear effects on objective measures of attention and wakefulness, with observed improvements linked to changes in the EEG theta/beta ratio—a biomarker indexing cortical arousal and attentional control. These findings replicate results from the Phase 1 study in healthy volunteers, where ALTO-203 treatment led to improvements in sustained attention and reductions in the EEG theta/beta ratio. Baseline EEG theta/beta ratio predicted attentional benefits of ALTO-203 in both the Phase 1 study and Phase 2 POC trial. 'We aim to leverage objective biomarkers to enable targeted neuropsychiatric drug development so that patients can get better, faster,' said Amit Etkin, M.D., Ph.D., founder and CEO of Alto Neuroscience. 'In this exploratory trial, we identified a robust biomarker for ALTO-203, EEG high-theta/beta ratio, which is a well-validated measure of abnormal cortical arousal and poor attentional control. Notably, this biomarker is FDA-cleared for use alongside clinical evaluation in the diagnosis of ADHD, reinforcing its clinical relevance. These positive results replicate findings from an ALTO-203 Phase 1 study and enhance our understanding of the patient subtypes most likely to benefit from the drug, further strengthening the foundation of our precision psychiatry approach. We believe our platform has the potential to enable data-driven indication selection and trial design early in development—accelerating the path to more effective, personalized treatment.' The exploratory Phase 2 POC trial, which enrolled 69 patients, was conducted in two sequential, double-blind, placebo-controlled periods. The trial was designed to characterize the pharmacodynamic, pharmacokinetic, safety, and tolerability profile of ALTO-203 across two dose levels compared to placebo in a crossover design and was not powered to detect statistical significance on traditional depression outcome scales (e.g., MADRS). Adam Savitz, M.D., Ph.D., Chief Medical Officer of Alto Neuroscience, commented, 'We are encouraged by the positive pharmacodynamic activity observed in the study, which aligns with the proposed mechanism of ALTO-203. The wake-promoting and pro-cognitive effects demonstrated, suggest clear potential for ALTO-203 to be a meaningful treatment across various neuropsychiatric conditions in which sleep and attention are significantly impaired.' Topline, prespecified results from the exploratory Phase 2 POC trial of ALTO-203 include: Subjective Effects on Bond & Lader Visual Analog Scale (BL-VAS): Patients reported significant improvements from baseline on BL-VAS for alertness & mood at the 5-hour timepoint post dosing with ALTO-203. A higher-than-expected placebo response was observed on the Bond & Lader measurements – no significant separation between ALTO-203 and placebo was observed. EEG Biomarker of Drug Effect Identified: The theta/beta ratio, a neurophysiological marker linked to attentional control, was confirmed as a key pharmacodynamic readout. The effects of ALTO-203 on reducing theta/beta ratio were significant compared to placebo (25µg: p<0.05). This marker was previously shown to be significantly reduced by ALTO-203 in the completed Phase 1 study in healthy subjects, as well as in preclinical studies. Cognitive Enhancement Observed: ALTO-203 treatment led to significant improvements in sustained attention (25µg: p<0.05; 75µg: p=0.06 vs. placebo), aligning with reductions in the EEG theta/beta ratio. Improvement in attention was greatest in patients with high baseline theta/beta ratios (i.e., more abnormal) (25µg: p<0.01; 75µg: p<0.05 vs. placebo). The observed improvements in attention and corresponding changes in EEG theta/beta ratio replicated significant findings from the Phase 1 study. Wearable Device Confirmation: Objective sleep measures from wearable devices supported the wake-promoting effects of ALTO-203, and the increased wakefulness exhibited by ALTO-203 was significant for both doses (25µg: p<0.05; 75µg: p<0.001 vs. placebo). Pharmacokinetics and Safety: ALTO-203 displayed predictable accumulation over multiple doses with no adverse pharmacokinetic signals. ALTO-203 was well tolerated, with insomnia as the most frequent adverse event, consistent with its wake-promoting profile. MADRS Improvements: Patients taking 25µg of ALTO-203 exhibited a mean improvement of 2 points at week 3 and 0.9 points at week 4 compared to placebo. The differences were not observed in the 75µg dose group. MADRS improvements were evaluated during the 28-day multi-dose period, which was not powered to detect significance. Alto plans to report additional results from this exploratory study at a future medical meeting and expects to determine the next development steps for ALTO-203 following the complete analysis of the data set. About the Phase 2 POC Trial of ALTO-203 The Phase 2 POC trial enrolled 69 MDD patients with higher levels of anhedonia consisted of two dosing periods (63 completed the primary single-dose period): Single-dose period: Patients received two single-doses of ALTO-203 (25µg and 75µg), and placebo in a randomized, three-way crossover design. The powered primary outcome was an acute change in positive emotion assessed by the alertness and mood components of the Bond-Lader Visual Analog Scale (BL-VAS), an established scale of subjective feelings. Key pre-specified exploratory outcomes included measures of cognition, EEG changes, and effects on sleep. Multi-dose period: Patients were randomized to receive daily administration of ALTO-203 (25µg or 75µg QD) or placebo over 28 days. This period was designed to evaluate extended safety, tolerability, and pharmacokinetics, as well as exploratory biomarkers across EEG, cognitive testing, and wearable device data. About Alto Neuroscience Alto Neuroscience is a clinical-stage biopharmaceutical company with a mission to redefine psychiatry by leveraging neurobiology to develop personalized and highly effective treatment options. Alto's Precision Psychiatry Platform™ measures brain biomarkers by analyzing EEG activity, neurocognitive assessments, wearable data, and other factors to better identify which patients are more likely to respond to Alto product candidates. Alto's clinical-stage pipeline includes novel drug candidates in bipolar depression, major depressive disorder, treatment resistant depression (TRD), and schizophrenia, and other mental health conditions. For more information, visit or follow Alto on X. Forward-Looking Statements This press release may contain forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as 'expects,' 'plans,' 'will' and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding Alto's expectations about the potential benefits, activity, effectiveness and safety of its product candidates and Precision Psychiatry Platform ('Platform'); the reproducibility of any favorable results seen in the exploratory Phase 2 POC trial of ALTO-203 in major depressive disorder; and Alto's expectations with regard to the design and results of its clinical trials. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including uncertainties inherent in the initiation, progress and completion of clinical trials and other important factors, any of which could cause Alto's actual results to differ from those contained in the forward-looking statements, which are described in greater detail in the section titled 'Risk Factors' in Alto's Annual Report on Form 10-K for the fiscal year ended December 31, 2024 filed with the Securities and Exchange Commission ('SEC') as well as in other filings Alto may make with the SEC in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and Alto expressly disclaims any obligation to update any forward-looking statements contained herein, whether because of any new information, future events, changed circumstances or otherwise, except as required by law. Availability of Information on Alto's Website Alto routinely uses its investor relations website to post presentations to investors and other important information, including information that may be material. Accordingly, Alto encourages investors and others interested in Alto to review the information it makes public on its investor relations website.
Business Wire
4 days ago
- Health
- Business Wire
Empatica Unveils EmbraceMini: The World's Smallest Actigraphy Wearable for Clinical Trials
BOSTON--(BUSINESS WIRE)-- Empatica, a pioneer in digital biomarker development and patient monitoring using wearables and AI, today unveiled EmbraceMini, its revolutionary new wearable for clinical trials. We've created a wearable that combines the reliability of a medical device with the accessibility of a design accessory, something previously missing from the market. - Matteo Lai, Empatica's CEO and Co-founder Share EmbraceMini is an ultra-compact health monitoring device, focused on delivering exceptional wearability and high-quality data without compromising sponsor or participant needs. With its incredibly small footprint and refined looks, EmbraceMini offers effortless, seamless and non-invasive activity data collection while prioritizing the patient experience at all times. It wirelessly transmits sensor data to the FDA-cleared Empatica Health Monitoring Platform, enabling the continuous analysis and extraction of precise digital biomarkers from clinical trial participants while boosting compliance. 'We've created a wearable that combines the reliability of a medical device with the accessibility of a design accessory, something previously missing from the market,' said Empatica's CTO and Co-founder, Simone Tognetti. 'Most devices adopted in clinical trials today are too bulky, or just not fit for purpose. Wearability is crucial for the success of the study, so our goal with EmbraceMini was to make a compact, beautiful wearable that offers the same data quality and range as EmbracePlus, without 'competing' with people's favorite watches or accessories for room on their wrist.' At just 12mm thick and 14mm wide, EmbraceMini is the smallest wristworn actigraphy device for clinical research in the world – the size of an AA battery. It is purpose-made for studies that track sleep and movement, with a long battery life that can achieve at least 7 days of continuous data collection. EmbraceMini can passively monitor over 200 digital measures, including digital biomarkers across physical activity, sleep, gait, and light exposure. These can serve a key role as digital endpoints in trials on sleep disorders, movement disorders, obesity, depression, pain, and more. In addition, EmbraceMini can collect raw sensor data, providing more transparency and flexibility in how information can be processed. Thanks to Empatica's modular approach, EmbraceMini can be worn on the wrist, leg, around the waist, or the ankle. Empatica allows simultaneous data collection using multiple devices, so researchers can combine data from Empatica's flagship wearable EmbracePlus (including cardiorespiratory measures) and EmbraceMini, or use two EmbraceMini units worn at different body locations for richer insights. Besides working seamlessly with Empatica's software, EmbraceMini can also be integrated into existing Clinical Trial Management Systems using a Cloud API. FDA clearance for EmbraceMini is expected in late 2025. If you are interested in learning more about the device and to request a demo, visit or write to Empatica at research@ Empatica Empatica Inc is a pioneer in continuous, unobtrusive remote health monitoring driven by AI. Empatica's FDA-cleared platform and technology are used by thousands of institutional partners for research purposes, in studies examining stress, sleep, epilepsy, migraine, depression, addiction, and other conditions. Its flagship medical wearable, EmbracePlus, has been developed with key partners including HHS, USAMRDC, and the NASA-funded TRISH.
