Imidex, a leading medical device company specializing in utilizing AI for lung nodule and mass detection, and Orbit Genomics, a pioneer in DNA sequencing for precision cancer diagnosis, today announced a strategic relationship aimed at helping to reduce the number of lives lost to lung cancer. Lung cancer is currently the leading cause of cancer-related deaths around the world. 

“Imidex’s technology is one of the only FDA 510(k) cleared devices capable of screening broad populations and incidentally detecting lung nodules and masses from chest x-rays. This positions us as the front-end solution to identify high-risk populations for further evaluation at the lowest cost,” said Wes Bolsen, CEO of Imidex. “By leveraging chest x-ray, we have the ability to opportunistically identify millions more patients with pulmonary nodules that are unwilling or not qualified to get a low dose radiation CT scan.”

Low-dose computed tomography (CT) is currently the standard method for lung cancer screening in high-risk patients in the United States. However, less than 6% of high-risk patients in the U.S. undergo this screening, with some states reporting rates as low as 1%. Chest x-ray (CXR) offers a broader reach for the screening and incidental detection of lung nodules, which are often early indicators of lung cancer. Imidex’s FDA 510(k) cleared VisiRad XR device has demonstrated an 83% sensitivity in detecting lung nodules as small as 6mm in CXRs, positioning it as an important tool for the identification of critical pulmonary findings that are often missed.

Dede Willis, President & CEO of Orbit Genomics, commented, “This is a natural formation of a strategic relationship between two companies focused on the same goal: saving lives lost to cancer. We are preparing to start clinical trials for our first product, OrbiSeq-L, for diagnosing lung cancer in patients with indeterminate pulmonary nodules found through low-dose CT. Imidex’s technology is the top of the lung cancer identification funnel, utilizing chest x-rays rather than CT scans to detect potential cancer patients who might otherwise go undiagnosed. Orbit Genomics can then immediately test those identified lung nodule patients with OrbiSeq-L, providing highly specific insights from a simple blood sample into their condition and directing them to the most effective forms of care.”

The OrbiSeq technology platform extends beyond cancer detection, with applications in a wide range of diseases and conditions, including heart disease and neurological disorders. OrbiSeq uses AI to analyze repetitive DNA which mutates rapidly and reflects overall genome stability, serves as ideal regions of interest for studying age-related diseases and conditions. OrbiSeq also evaluated regions for ethnicity and gender bias, ensuring that products are effective for everyone. Orbit Genomics has demonstrated the ability to detect diseases early and predict drug efficacy in individuals, making the technology a valuable tool for personalized medicine.

This collaboration between Imidex and Orbit Genomics represents a significant step forward in the fight against lung cancer and other complex diseases, with the potential to save countless lives through early detection and intervention.

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The AR Alliance announces that Qualcomm Technologies, Inc. has become the last founding member added to the board of directors.

The AR Alliance provides a supportive and neutral environment for organizations of all sizes to take an active role in advancing and strengthening the augmented reality hardware development ecosystem. Diverse organizations across the expanding, global AR ecosystem work together through the AR Alliance to speed innovation of breakthrough technologies and processes for building AR wearables and devices that create a meaningful and positive experience for users.

“The founding members are driving AR together,” said Dr. Bharath Rajagopalan, chair, AR Alliance, and director of strategic marketing, STMicroelectronics. “The promise of AR and its potential industry are so vast that there is ample room for all our member companies to work together. The AR Alliance is the place where concrete work takes place to harmonize approaches for advancing, unifying, and growing the global AR supply chain and accelerating innovation. We are excited that Qualcomm Technologies has joined the alliance as they bring a key piece to the hardware ecosystem through enabling platforms for the development of applications, and with their years of experience in this space, their industry leading technology and deep market experience.”

“For over a decade, we’ve been committed to accelerating innovation and enabling the XR ecosystem with our Snapdragon® XR Platforms, powering many of the XR hardware available today. We are thrilled to be joining the AR Alliance to continue strengthening the XR industry,” said Said Bakadir, Senior Director, Product Management at Qualcomm Technologies, Inc. “We look forward to contributing our experience and expertise alongside the members of the AR Alliance to help grow the augmented reality space.”

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Dr. Ehud Baron brings his expertise in blood pressure, hemodynamics, health mapping, and AI-driven diagnostics to this strategic collaboration. This partnership highlights UTime’s new commitment to enhancing health and wellness through cutting-edge medical wearable technology. With support from strategic collaborations and advanced research, UTime strives to deliver effective global solutions for disease prevention and health management.

Dr. Ehud Baron was a former professor at the Israel Institute of Technology, UC Berkeley, and Stanford University. He also founded and led several companies in cardiology, sleep, and AI sectors.

In light of the heightened global emphasis on health and disease prevention following the 2019 COVID-19 pandemic, UTime has prioritized the development of advanced medical wearable products. In 2024, UTime and Dr. Ehud Baron embarked on a strategic initiative to create a new blood pressure monitoring watch utilizing Dr. Baron’s continuous blood pressure measurement technology. The collaboration with Dr. Ehud Baron is expected to play a key role in advancing UTime’s efforts in blood pressure monitoring solutions. Moving forward, UTime is dedicated to expanding its range of medical wearable products, leveraging Dr. Baron’s expertise to meet the growing demand for advanced health technologies worldwide.

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SoundHealth, Inc. (“SoundHealth”), a medical technology company harnessing the power of artificial intelligence and medical science to improve patient outcomes, today introduced SONU. SONU is the world’s first FDA De Novo authorized, AI-enabled, wearable medical device for the treatment of moderate to severe nasal congestion due to allergic and non-allergic rhinitis for at-home use by individuals 22 years of age and older. SONU provides a new non-pharmaceutical treatment option for patients and clinicians. The United States Food and Drug Administration (FDA) issued a De Novo classification for the SONU product, which includes the SONU device and the SONU app.

$7 million seed-round funding for marketing and expanded indications

In parallel with the official launch of SONU, SoundHealth received $7 million of seed-round funding. SoundHealth will use the funds to enhance the commercialization and marketing of SONU and to seek regulatory authorization for additional indications for pediatric use and insomnia. Moai Capital and J4 Ventures led the round with additional funding from TeleSoft Partners, Tau Ventures, TechU Ventures and Rhythm Venture Capital. Peter Moran, an early-stage investor in digital health and wellness companies, a former long-time managing partner at DCM Ventures, and a seed investor in SoundHealth, will join the SoundHealth board of directors. The investor syndicate has a long track record of successful investments in groundbreaking solutions from both enterprise and health tech startups.

“We are delighted to announce the close of our seed-round investment — the proceeds of which will be used for product launch and advancing our pipeline of indications for the SONU device. Our groundbreaking technology provides the first FDA authorized, non-pharmaceutical medical device treatment option for nasal congestion due to allergic and non-allergic rhinitis. SoundHealth’s mission is to provide personalized, intelligent wearables to help people breathe and sleep better!” said Dr. Paramesh Gopi, founder and CEO, SoundHealth.

“SONU is using the latest medical science to provide a game-changing and liberating alternative treatment for nasal congestion. Investors are increasingly looking for high-efficacy solutions to many maladies without the side effects of pharmaceutical approaches. I look forward to working with SoundHealth’s tenured team in helping many people find relief from nasal congestion with this simple yet powerful, non-invasive device without the side effects often associated with pharmaceuticals,” said Moran.

“We were especially struck by how quick and easy SONU can bring relief to allergies, without using a drug. Future applications could include helping with sleep and stress,” said Amit Garg, managing partner of Tau Ventures.

SONU provides acoustic resonance therapy for nasal congestion

SONU is an AI-enabled patented drug-free medical device that uses acoustic vibrational energy to provide personalized relief for nasal congestion. Acoustic vibration associated with humming has been shown to decrease symptoms of nasal congestion, possibly through modulation of autonomic inputs to the nasal mucosa or through nitric oxide activity, which may in turn exert a decongestant and anti-inflammatory effect on the nasal passages.

Yogic breathing exercises that incorporate humming have been practiced for centuries and have recently been demonstrated clinically to reduce symptoms of chronic sinusitis including nasal congestion.

Published research and panel discussion on acoustic resonance therapy at American Rhinologic Society’s Summer Sinus Symposium

An article presenting the results of a SoundHealth-sponsored clinical trial of acoustic resonance therapy, published by the International Forum of Allergy & Rhinology, is available here. In addition to co-authoring the article, SoundHealth founder and Head of Research Dr. Peter Hwang, MD, FARS, participated in a panel, “Acoustic Energy and Vibration Therapy of the Sinonasal Cavity,” on July 12, 2024 at the American Rhinologic Society’s 13^th Annual Summer Sinus Symposium. Attendees learned the principles, practical applications, devices and techniques of optimizing treatment for rhinitis using acoustic energy and vibration therapy. The American Rhinologic Society (ARS) is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians, which includes attending the Summer Sinus Symposium.

“SONU’s vibroacoustic therapy offers an innovative drug-free treatment option for my patients suffering from allergic and non-allergic nasal congestion. The prospect of replacing medications with a scientifically proven non-invasive therapy is truly exciting,” said Dr. Cecelia Damask, DO, FAOCO-HNS, FAAOA, a physician at Orlando and Lake Mary ENT & Allergy, board-member-at-large for the American Osteopathic Colleges of Ophthalmology and Otolaryngology-Head and Neck Surgery (AOCOO-HNS), coordinator of education for the American Academy of Otolaryngic Allergy (AAOA), chair-elect of the Allergy, Asthma, and Immunology Committee for the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) and assistant professor in the Department of Otolaryngology at the University of Central Florida College of Medicine.

“SONU is a really interesting technology. It’s based on the really old understanding that when we hum or sing or whistle, our sinuses open, and we also feel very relaxed. The vibration relaxes the sympathetic and parasympathetic parts of our autonomic nervous system; it opens our sinuses with resonance, improves the flow of mucus in the nose and promotes ciliary action. SONU was designed based on what we know about vibrations and acoustic resonance, without any medications, and the patient can do whatever else they want while using the SONU band. We’ve waited a long time in our field for a product that can help manage nasal congestion, sinus pressure and tension in the head and neck in such an elegant way, so that the whole experience is wonderful for our patients. It’s a very good alternative to the other options of medications, allergy management, surgery and office procedures. So, I’m excited to add SONU to the toolkit for patients with nasal congestion,” said Dr. Jacob Johnson, MD, president, San Francisco Audiology, ENT specialist, San Francisco Otolaryngology Medical Group, and associate clinical professor, University of California, San Francisco.

SONU uses AI for personalized therapy based on patients’ unique anatomy

SONU is easy, convenient and pleasant to use for patients. Using SoundHealth’s proprietary AI technology, the SONU app scans their face using a smartphone, creates a digital map of their sinuses and calculates 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 SONU band delivers frequencies tailored to the patient based on the app’s calculations. Symptom relief begins in minutes. Patients do not need to change their activities while using SONU. They can enjoy SONU anytime at home just for 15 minutes twice a day, for example, while online, brushing their teeth, drinking their morning coffee, exercising or watching TV.

The SONU band produces resonant sound waves that gently vibrate the nasal cavity. These micro vibrations are so small they may not even be noticeable, and they stimulate nasal nerves, which may result in vasoconstriction, which reduces swelling and opens nasal passages; sonication, which dilutes accumulated dense mucus; and mucociliary clearance, which drains healthy mucus. SONU represents a brand-new category of safe and rapid relief therapies for nasal congestion, and spares patients from the side effects commonly associated with pharmaceutical treatment options.

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Based in Houston, Velentium designs, develops, manufactures, and provides post-market support for medical devices, particularly active implantable and wearable devices. With expertise in systems engineering, software, cybersecurity, mobile/cloud solutions, and automated test systems, Velentium collaborates with clients worldwide to create medical solutions that improve lives.

“Velentium brings unique capabilities to their medical device customers and is a trusted partner to help drive new product innovation,” said Ryan Kaeding, Managing Director, Life Sciences at Trinity. “We believe in their team and are excited to help accelerate their growth as a one-stop shop for end-to-end medical device design, development, and contract manufacturing.”

Velentium recently moved into their new corporate headquarters in Houston, which is over 50,000 square feet, has class 7 cleanrooms and provides a significant improvement in their manufacturing capacity to support their growing contract manufacturing business. The new debt facility from Trinity will facilitate Velentium’s continued growth.

“We are thrilled to partner with Trinity as we continue to scale our business and make medical devices safer, more secure, and more user-friendly continuing our mission to Change Lives for a Better World through our customer partnerships.” said Dan Purvis, CEO of Velentium.

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Delcon, an Italian company specializing in medical devices and software for the transfusion sector, today announced the launch of OpenChair, a software solution that leverages AI to increase blood donation appointments. The platform sends messages direct to blood donors to encourage appointment bookings. Delcon launched OpenChair at the annual ADRP conference in St. Louis, Missouri.

Developed in collaboration with the international venture studio Co-Created, OpenChair addresses one of the most common challenges in blood donation. Recruiting new donors is slow and costly, making the continuous contribution of frequent donors essential for maintaining sufficient blood reserves year-round. OpenChair aims to engage this group by automatically creating personalized messages designed to capture their interest and encourage them to book another donation appointment.

Several tests with US partners, including Blood Assurance, Gulf Coast Regional Blood Center, Impact Life, and Central California Blood Center, have yielded remarkable results. Communications sent by the Gulf Coast Regional Blood Center in Texas using OpenChair saw a 24% increase in appointments among inactive donors and a 35% increase in donations from frequent donors compared to traditional methods used during the same period. This could potentially result in tens of thousands of additional donations annually for each center.

Theresa Pina, VP of Operations at Gulf Coast Regional Blood Center, commented: “We partnered with OpenChair to pilot a personalized approach to donor communications, including location-based targeting in campaign strategies. The pilot results show we could change how we engage donors to ensure a steady blood supply and make our donor communications more quality than quantity.”

The software works by analyzing donor characteristics, grouping them based on demographic, health, and various other data related to their donation experiences. The system generates personalized messages, refining and adjusting the content based on recipients’ responses and interactions. This allows the system to address hyper-specific needs identified from initial or ongoing data, such as availability and responsiveness to different communication styles. This capability enables blood centers to build a rich, detailed database of their donors over time, facilitating better understanding of their needs and a more effective communication.

“Our platform can truly make a difference in donation volumes,” says Barbara Sala, CEO of Delcon. “With OpenChair, we add a crucial component to our services supporting blood centers, all aimed at streamlining processes through technological innovation and digitalization. Our ecosystem of products addresses various steps across the blood center value chain: it starts with donor recruitment and engagement facilitated by OpenChair, followed by blood collection with our advanced Milano blood collection mixer, and blood components manufacturing with the state-of-the-art Giotto Monza device. All these solutions are unified under a single platform, enabling efficient data collection and integration throughout the entire process.”

Delcon, which currently employs more than 60 people, closed 2023 with a double digit increase on the previous year. Thanks to its data-driven approach, Delcon’s footprint in the American market is increasing, positioning the company as one of the emerging leading suppliers for blood centers in the US. The Milano smart scale, a co-designed project with the New York Blood Center, was developed to facilitate field operators’ work based on their needs. It is now the company’s flagship device. The device won the Compasso d’Oro award in Italy for its design in 2021. Over the past three years, the US market has emerged as a significant contributor to the company’s global revenue stream, accounting for an average of 25% of the blood bank total business.

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Frost & Sullivan has named Evidation the 2024 Honoree of the Best Practices Customer Value Leadership Award for Real-World Evidence Solutions in Healthcare. Frost & Sullivan recognizes Evidation’s transformative approach in harnessing consented real world data directly from individuals to deeply characterize and understand health and disease.

Evidation’s research solutions allow healthcare and life sciences organizations to connect directly with individuals to better measure, understand, and improve health. Evidation uses data from wearables, surveys, and electronic patient-reported outcomes (ePROs) to get a more complete picture of symptoms, disease progression, treatment impact, quality of life, and social determinants of health. Through its decentralized approach and ability to engage millions over the long term, Evidation is reimagining health research to make it faster, more precise, more inclusive, and more transparent.

“Evidation’s dedication to patient-centricity transcends mere rhetoric, and focuses on respect for problems, people, and customers. The emphasis on ‘real’ RWD sets it apart, providing a holistic understanding beyond conventional EHR and claims data,” said Ojaswi Rana, Best Practices Research Analyst. “This approach broadens the focus from patients to at-risk and healthy individuals, contributing to a more nuanced perspective on health and disease.”

The Evidation app is used by a community of almost 5 million people in 97% of U.S. ZIP codes, who are rewarded for engaging in healthy activities and contributing to health research; over one million individuals have participated in research on Evidation. Members earn points, which can be redeemed for cash or charitable donations, by tracking activities like walking, sleeping, and logging food and for participating in research surveys and studies. Evidation prioritizes transparency and consent by always obtaining user permission for data use and sharing. Participants can opt-in to sharing additional health data with researchers, including pharmacy claims and electronic health record data.

“Evidation’s large, highly characterized, and responsive population ensures rapid access to diverse data for bespoke data collection. Its direct, two-way connection with members also enables customers to quickly re-contact patients for follow-up questions and contextualize data sets,” said Unmesh Lal, Research Director at Frost & Sullivan. “The company’s technology platform is also a differentiator, due to its success in driving high engagement and protocol adherence rates at scale over long periods.”

Evidation’s solutions include:

• Recruitment: Recruit directly from Evidation’s engaged, diverse community to rapidly enroll individuals into research.
• Research: Deploy Evidation’s retrospective and prospective research solutions to measure health in everyday life.
• Platform: License Evidation’s platform to conduct long term, digitally enabled, direct-to-participant research programs.

The Best Practices Customer Value Leadership Awards is part of Frost & Sullivan’s ongoing effort to identify visionary companies at the forefront of innovation and growth. For more information on Evidation’s health research solutions, please visit evidation.com.

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Nihon Kohden, renowned for its history of excellence in providing innovative high quality, reliable medical technology that improves the way healthcare is practiced, is partnering with Medasense to introduce its nociception monitor to the Japanese market. This cutting-edge device, with its state-of-the-art AI powered NOL – Nociception Level Index®, provides real-time, objective pain monitoring, enabling the personalization and optimization of pain treatment. It will be accessible to hospitals and clinics throughout Japan through Nihon Kohden’s extensive distribution channels pending regulatory approval.

Medasense’s CEO & Founder, Galit Zuckerman, expressed enthusiasm about the collaboration: “We are honored to partner with Nihon Kohden, a company with a long history of excellence, that shares our vision of improving patient care through innovative solutions. Our mission is to help all patients suffer less from pain and the adverse effects of pain medication. Nihon Kohden’s established clinical, technological leadership and expertise in the Japanese market make them the perfect partner to distribute our nociception monitor.”

NOL monitoring provides an AI powered, clinically validated index to objectively quantify the physiological response to pain (nociception) supporting clinicians in delivering personalized anesthesia tailored to patient requirements. With over 40 peer reviewed publications, clinical studies have demonstrated that NOL-guided analgesia resulted in intraoperative opioid sparing, and improved post operative pain scores and patient recovery.^1,2

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JOGO Health (JOGO), a medtech company treating chronic pain and neuromuscular disorders, announced it has closed over $5.5 million in an investment round led by Hourglass Ventures. Due to high demand, the company is opening the round to public retail investors via a Regulation CF community investment round on Wefunder, inviting retail investors to join alongside firms like Mayo Clinic Ventures, the venture arm of the world-renowned hospital.

JOGO’s wearable technology and app leverage the brain’s natural neuroplasticity to provide non-invasive, drug-free relief for conditions including chronic lower back pain, stroke recovery, migraines, and incontinence. Cleared by the FDA and reimbursed by Medicare and commercial insurance, JOGO is expanding a $380B market without drugs or surgery, supported by 18 patent claims across all neuromuscular conditions. JOGO has already treated 25,000+ patients across 50+ hospital channel partners, including Mayo Clinic, Mount Sinai Hospital, and Brigham and Women’s Hospital.

Led by a team of accomplished healthcare entrepreneurs, JOGO’s team brings experience from Columbia University, Harvard University, Yale University, AT&T, Johnson & Johnson, and Astrazeneca. Co-Founder and CEO Sanjai Murali built JOGO from zero to FDA market authorization. Siva Nadarajah, President and Co-Founder, previously sold an AI healthcare startup to leading clinical research company IQVIA, delivering a 10x return to investors.

“The conviction of our investors is phenomenal,” added Siva Nadarajah, President and Co-Founder. “This round will enable us to meet growing demand.”

“We believe healthcare is too important to be controlled by a few,” said Sanjai Murali, CEO and Co-Founder. “JOGO is founded on the vision of ‘by the world, for the world,’ and opening our investment round to retail investors on Wefunder is a crucial step towards realizing this vision.”

Capital raised will support JOGO’s commercial launch, putting JOGO on track to become the first line of treatment for chronic pain and other neuromuscular disorders – impacting 1 in 5 people globally. The community investment round is open to everyone via Wefunder, with a minimum investment of $100.

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The AR Alliance announces that Google will become the next founding member with a seat on the board of directors.

The AR Alliance provides a supportive and neutral environment for organizations of all sizes to take an active role in advancing and strengthening the augmented reality hardware development ecosystem. Diverse organizations across the expanding, global AR ecosystem work together through the AR Alliance to speed innovation of breakthrough technologies and processes for building AR wearables and devices that create a meaningful and positive experience for users.

“We are building AR together,” said Dr. Bharath Rajagopalan, chair, AR Alliance, and director of strategic marketing, STMicroelectronics. “The promise of AR and its potential market are so vast that there is ample room for all our member companies to succeed together. The AR Alliance is the place where concrete work takes place to harmonize approaches for advancing, unifying, and growing the global AR supply chain and accelerating innovation. We are excited for Google to join us in this important work and bring their technology leadership, deep market understanding and unique market experiences and perspectives to help propel the AR market.”

Steve Goldberg, Director, Next-Gen HW/SW Platforms, at Google added “Our mission is to organize the world’s information and make it universally accessible and useful. AR technologies, like those the AR Alliance is working on, have the potential to transform how we interact with information by blending our physical and digital worlds. We look forward to partnering with AR Alliance and its members to continue exploring the possibilities of AR and how it can be harnessed to solve real-life everyday challenges.”

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