Latest news with #LindusHealth
Yahoo
10 hours ago
- Business
- Yahoo
Lindus Health Named Fierce CRO Award Winner in the Outstanding Patient Recruitment and Retention Category
BOSTON, June 18, 2025 /PRNewswire/ -- Lindus Health, the anti-CRO running radically faster, more reliable clinical trials, has been honored the winner in the 2025 Fierce CRO Awards' Outstanding Patient Recruitment and Retention category, which celebrate exceptional achievements and innovations by Contract Research Organizations (CROs). These awards spotlight CROs that exemplify innovation, performance, and leadership in advancing life sciences research and improving patient outcomes. Lindus Health earned this recognition for its innovative use of the Patient Identification Center (PIC) technique, which leverages advanced algorithms and customized search protocols based on real-world medical record data to reduce screen fail rates and accelerate recruitment with greater precision. This approach was instrumental in its collaboration with Myota on a pre-diabetes trial, which achieved a 54% screening conversion rate—five times the industry benchmark—and completed enrollment in just four months. Backed by deep expertise in healthcare data, clinical systems, and physician behavior, Lindus Health's unique PIC approach stands out not just for using EHR-driven participant searches, but for how it executes them. While many CROs rely on medical practices to run standard queries, Lindus builds its own highly customized, in-house searches. These go beyond basic inclusion and exclusion criteria, incorporating a nuanced understanding of how data is actually recorded and coded by general practitioners. For example, when a trial sought patients with "reduced sexual desire," Lindus optimized results by using "low libido"—a term more commonly coded by GPs—significantly improving the ability to identify eligible participants. "Receiving the Fierce CRO Award is a tremendous honor," said Meri Beckwith, co-founder of Lindus Health. "It reflects our mission to fix the broken clinical trial model so patients can access treatments faster. With innovative strategies like our PIC technique, smart study design, and proprietary AI, we're delivering faster, more precise, and cost-effective trials—even in complex cases. Our work isn't done though, and we're continuing to push the boundaries of what's possible in clinical research, making it more efficient, inclusive, and patient-centric every step of the way." This award comes on the heels of Lindus Health's Series B funding round of $55 million, which is fueling strategic hiring across clinical operations and product development, while expanding the capabilities of its proprietary AI-powered eClinical platform, Citrus™. The investment is enabling advancements in study design optimization, automated central monitoring, and real-time biostatistics. As the only major service provider with a fully in-house platform, Lindus integrates all core clinical research technologies—including CTMS, EDC, eDiary, visit scheduling, and more—into a seamless, unified ecosystem. In partnership with Oxford University, Lindus Health published a study on diverse perceptions of clinical trial participation, helping to inform more inclusive and patient-centered research. Additionally, Lindus is collaborating with CDISC, the organization that sets clinical data standards for the FDA, to develop standardized templates for clinical observations and is contributing to ARIA's Safeguarded AI program to improve trial design through safer, more reliable AI. The full Fierce CRO Awards report profiling all winners is available here. Lindus Health's award-winning capabilities can be found at About Lindus Health Lindus Health is an anti-CRO running radically faster, more reliable clinical trials for life science pioneers – bringing ground-breaking treatments to patients more quickly. This is achieved through a commercial model that aligns incentives (fixed-priced quotes per study, with milestone-based payments), a world-class clinical operations team with its unique software platform, and access to over 40 million Electronic Health Records. Clinical trials are the biggest bottleneck to advances in healthcare. Lindus Health removes this constraint through end-to-end execution of clinical studies driven by technology and forward-thinking approaches to clinical operations. To date, Lindus Health has delivered clinical trials across the US, UK, and Europe to tackle a range of conditions, including diabetes, asthma, acne, social anxiety, major depressive disorder, hypertension, chronic fatigue syndrome and insomnia. The company has raised over $80M from investors including Peter Thiel, Balderton, Creandum, Firstminute Capital, and Seedcamp. About Fierce BiotechFierce Biotech is the biotech industry's daily monitor, providing the latest news, articles, and resources related to clinical trials, drug discovery, FDA approval, FDA regulation, patent news, pharma news, biotech company news and more. More than 300,000 top biotech professionals rely on Fierce Biotech for an insider briefing on the day's top stories. Signup is free here. Press contact: Jodi PerkinsAmendola Communications for Lindus HealthJperkins@ Cell: 847.508.0877 View original content to download multimedia: SOURCE Lindus Health
Yahoo
14-03-2025
- Health
- Yahoo
Sooma gains FDA approval to commence study of tDCS device
Sooma Medical has received the approval of an investigational device exemption (IDE) from the US Food and Drug Administration (FDA), allowing the company to initiate a pivotal study of its transcranial direct current stimulation (tDCS) medical device, Sooma 2GEN, as a home-based treatment for major depressive disorder (MDD). The study will evaluate the efficacy and safety of the device, which is designed as a wearable cap that enables low-level electrical current delivery to the brain leveraging tDCS therapy. This non-invasive technique aims to ease symptoms of depression eliminating the need for pharmaceuticals. In collaboration with Lindus Health, Sooma Medical will conduct the trial involving 200 subjects across the US. Lindus Health will leverage its virtual site offerings for subject recruitment and trial management, employing Citrus, its eClinical platform, for study-related activities. Sooma's portable neuromodulation device provides a flexible and accessible treatment option for individuals with MDD. The device has already received breakthrough device designation from the US regulator. It claims to be a brain stimulation treatment that patients can utilise safely at home. Sooma 2GEN is already cleared for treating the condition in 35 countries The US trial's positive outcomes are expected to further substantiate the device's safety and efficacy, backing the company's efforts to gain clinical validation for the tDCS therapy in the US market. Sooma Medical CEO and co-founder Tuomas Neuvonen stated: 'Until now, early-stage treatment options have been limited for patients who don't respond to medication or lack access to therapy. Those who have tried several antidepressants without success are considered treatment-resistant, which affects their prognosis and hope for improvement. 'We're excited to partner with Lindus Health to generate the US data that will demonstrate Sooma 2GEN's capabilities in improving the quality of life in depression patients.' "Sooma gains FDA approval to commence study of tDCS device" 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. Sign in to access your portfolio
Yahoo
12-03-2025
- Health
- Yahoo
Sooma gains FDA approval to commence study of tDCS device
Sooma Medical has received the approval of an investigational device exemption (IDE) from the US Food and Drug Administration (FDA), allowing the company to initiate a pivotal study of its transcranial direct current stimulation (tDCS) medical device, Sooma 2GEN, as a home-based treatment for major depressive disorder (MDD). The study will evaluate the efficacy and safety of the device, which is designed as a wearable cap that enables low-level electrical current delivery to the brain leveraging tDCS therapy. This non-invasive technique aims to ease symptoms of depression eliminating the need for pharmaceuticals. In collaboration with Lindus Health, Sooma Medical will conduct the trial involving 200 subjects across the US. Lindus Health will leverage its virtual site offerings for subject recruitment and trial management, employing Citrus, its eClinical platform, for study-related activities. Sooma's portable neuromodulation device provides a flexible and accessible treatment option for individuals with MDD. The device has already received breakthrough device designation from the US regulator. It claims to be a brain stimulation treatment that patients can utilise safely at home. Sooma 2GEN is already cleared for treating the condition in 35 countries The US trial's positive outcomes are expected to further substantiate the device's safety and efficacy, backing the company's efforts to gain clinical validation for the tDCS therapy in the US market. Sooma Medical CEO and co-founder Tuomas Neuvonen stated: 'Until now, early-stage treatment options have been limited for patients who don't respond to medication or lack access to therapy. Those who have tried several antidepressants without success are considered treatment-resistant, which affects their prognosis and hope for improvement. 'We're excited to partner with Lindus Health to generate the US data that will demonstrate Sooma 2GEN's capabilities in improving the quality of life in depression patients.' "Sooma gains FDA approval to commence study of tDCS device" 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.
