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Headspace Health Expands Mental Healthcare Services to International Markets

Headspace Health Expands Mental Healthcare Services to International Markets

Headspace Health, the provider of the worldโ€™s most comprehensive digital mental health platform, announced the expansion of its care services for organizations headquartered outside of the U.S. Starting with the U.K. this month, Headspace Health now brings together Headspace’s world-class meditation and mindfulness offering with on-demand coaching, therapy and EAP services to provide a single mental health solution that reduces complexity, administrative burden and cost for employers. The company plans to extend these services into additional markets throughout 2023.

The pandemic and global economic pressures have exacerbated the mental health crisis around the world with employees increasingly looking to their employers for support. A recent U.K. Corporate Mental Health Benchmark Report byย CCLAย revealed 93 out of 100 companies assessed acknowledge workplace mental health as an important business issue. While employee mental health support is an increasing topic of significance on company agendas, more work is required in this area to enact real change. Aย recent Headspace Health studyย revealed that one in three British workers feel their employer isnโ€™t doing enough to support their mental health, and over half (63%) admit they missed at least one day of work over a 12 month period due to stress, anxiety, or other mental health challenges.

The Headspace Health stepped-care approach is designed with an emphasis on prevention, providing employees with the ability to increase or decrease the level of support they need as individual needs change over time. The end-to-end offering includes:

  • Self-Guided Care: On-demand, self-guided activities through the Headspace app to build proactive skills and enhance everyday wellbeing. Employees can access more than 1,000 hours of mindfulness content from evidence-based guided meditations, eyes-open exercises like mindful walks and runs, breathing and wind-down exercises, focus music, sleep content and more.
  • Behavioral Health Coaching: Unlimited 24/7 access to a team of highly-trained Headspace Health behavioral health coaches to build coping skills and manage day-to-day stressors related to general wellness, work, family and relationships, among others. Coaching is delivered via text with a market-leading response time โ€“ within two minutes โ€“ so employees can access the support they need in real time.
  • Therapy: High-quality clinical care delivered by video, phone or in person by licensed therapists trained in a range of clinical specialties and evidence-based treatments, such as Cognitive Behavioral Therapy (CBT). Employees are able to request a therapist based on their personal preferences once they reach out for clinical support.
  • EAP Services: In addition to the above framework, a dedicated EAP account specialist can ensure employees have access to support for issues ranging from eldercare and childcare to financial and legal support.

โ€œWeโ€™re creating the mental health solution youโ€™d design if you were creating the system from scratch,โ€ said Russell Glass, CEO of Headspace Health. โ€œPeople know and love Headspace, so it creates an approachable, engaging front door for individuals who can then access higher levels of care as needs arise. Expanding this complete capability into the U.K. today constitutes a major milestone in our journey toward transforming mental healthcare to improve the health and happiness of the world.โ€

Dr. Dana Udall, Ph.D., chief clinical officer of Headspace Health, added, โ€œHaving pioneered this integrated offering in the U.S., we are thrilled to deliver a full-suite solution to organizations internationally. Of the existing Headspace Health members using our stepped-care model, 80% have their needs fully met via coaching and content alone, with an average 4.85/5 satisfaction with our coaches and clinical care providers. Ourย studiesย show that using more cost-effective forms of care in accessible environments delivers similar levels of improvement while reserving clinical capacity for those who truly need it.โ€

FDA Approves Abbott’s Spinal Cord Stimulation for Diabetic Peripheral Neuropathy

Abbott announced that the U.S. FDA has approved its Proclaim XR spinal cord stimulation system to treat painful diabetic peripheral neuropathy (DPN), a debilitating complication of diabetes. The Proclaim XR SCS system can provide relief to DPN patients in need of alternatives to traditional treatment approaches, such as oral medication. People who receive therapy from the Proclaim XR SCS system will also be able to use Abbott’s NeuroSphereโ„ข Virtual Clinic, a connected care app that allows people to communicate with a physician and receive treatment adjustments remotely.

Roughly 34.2 million Americans, or 10.5% of the U.S. population, have diabetes.3ย Diabetic neuropathy, one of the complications of diabetes, is a type of damage seen predominately in nerves running to the feet.4ย During their lifetime, approximately 50% of adults with diabetes will develop peripheral neuropathy, which may include symptoms such as pain and numbness in the legs, feet and hands.5

Currently, there are no disease modifying treatments for DPN, only symptom management and behavioral modifications to mitigate further nerve damage that can result from high blood sugar (glucose) levels.6ย Spinal cord stimulation is a non-opioid approach that has been used for more than 50 years to help manage chronic pain and is proven to be more effective than conventional medical management in the treatment of this type of chronic pain.1,2ย As a global leader in diabetes care, Abbott is committed to bringing life-changing solutions, including diagnostics, nutritionals, medicines and medical devices such as spinal cord stimulation to help better the lives of people living with diabetes.

Approved for the treatment of chronic pain in 2019, the Proclaim XR SCS system now offers DPN patients relief from chronic pain by delivering low amounts, or doses, of stimulation. Unlike other SCS systems that require frequent charging sessions to maintain therapy, theย Proclaim XRย SCS system provides hassle-free pain relief with a battery that lasts up to 10 years at low-dose settings.ยงย People experiencing DPN can engage with their healthcare provider to be referred to a pain management specialist or spine surgeon to discuss the details of this treatment to determine the best course of care.

“Diabeticย peripheralย neuropathy has long plagued people affected by type 1 and type 2 diabetes,ย oftenย adding another areaย of disease managementย on top ofย their ongoing monitoring ofย their glucose levelsย toย manageย this challenging disease,”ย saidย Jason E. Pope, MD, DABPM, FIPP, president of Evolve Restorative Center inย Santa Rosa, Calif.ย “Abbott’sย Proclaimย XR spinal cord stimulation system providesย patients with painful diabetic peripheralย neuropathy the opportunity to obtain a better quality of life while more seamlessly fitting into their current lifestyles.”

Following a successful minimally invasive trial and undergoing an implant with the Proclaim XR SCS device, patients will have the ability to control their therapy through an Apple device. The device can also be programmed using the company’s proprietary NeuroSphere Virtual Clinic technology, a first-of-its-kind remote patient care technology in U.S. that allows users to communicate with physicians, ensure proper settings and functionality, and receive new treatment settings/adjustments remotely, as needed.

 

Sandoz Egypt Pharma and Ibnsina Pharma ink strategic partnership to improve patient access to OTC Products

Sandoz Egypt Pharma and Ibnsina Pharma ink strategic partnership to improve patient access to OTC Products

Sandoz Egypt Pharma and Ibnsina Pharma have announced a distribution and promotion agreement for the Sandoz over-the-counter (OTC) portfolio of products, strengthening the companyโ€™s commitment to widening access to products, with the help of Ibnsinaโ€™s expansive nationwide network. The broad outlines of the agreement amplify both companiesโ€™ efforts to reach a higher number of underserved patients.

Sameh Elbagoury, General Manager at Sandoz Egypt and Libya, said: โ€œOTC products are vital to advancing healthcare, and our partnership with a true market leader like Ibn Sina is an important step, catalyzing our ability on-ground to live up to our relentless commitment to improving access. Our OTC portfolio in Egypt currently spans eight products and we have concrete plans to expand, transforming it into one of our strategic pillars, alongside our generic and biosimilar drug portfolios.โ€

โ€œBy allowing people to recover from minor conditions like the common cold, allergies, minor pains and others, OTC products not only help people get back to enjoying their day-to-day lives faster, but they also help relieve the burden on the average citizen suffering from minimal symptoms, as well as on the healthcare system by aiding faster recovery and reducing the need for people to visit treatment facilities. In effect, OTC products are an indispensable part of the equation towards improved access to healthcare. Another important element of this partnership is knowledge-sharing and education, as it allows us to share the latest advances and scientific breakthroughs with pharmacist networks โ€“ the first and main point of contact for patients and consumers, ensuring that they remain at the forefront of the quest for science-driven health outcomes.โ€ added El Bagoury.

Mahmoud Abdel Gawad, Co-Founder and Co-CEO of Ibnsina Pharma, said, โ€œOur partnership with a recognized global leader like Sandoz is a testament that Ibnsina Pharma is the distributor of choice. The partnership will also boost our efforts to bring products to everyone in need, wherever they are. Ibnsina Pharma is the fastest-growing and second-largest pharmaceutical distributor in Egypt, with the capacity to efficiently deliver products to a large number of patients and consumers, leveraging innovative digital solutions to optimize performance.โ€

โ€œOur combined knowledge, expertise, and assets are definitive to helping us address coverage gaps across Egypt and achieving a breakthrough in access so that affordable, high-quality products are accessible and within easy reach. This agreement enables us to strengthen our position in the area of OTC products, helping us reach out to more pharmacists, and allowing us to optimize accessibility to non-prescription products for patients. We are proud of the network we have established which allows us to supply pharmaceuticals and cosmetics to more than 49,000 private and public-sector customers including pharmacies, hospitals, wholesalers, and health institutions, using a fleet of around 830 vehicles,โ€ added Abdel Gawad.

Sandoz launched its OTC portfolio in Egypt in early 2022, offering non-prescription products covering a variety of therapeutic areas including gastrointestinal diseases, pain management, respiratory conditions and pediatric vitamins and supplements. While ultimately bolstering access to products and bringing value to the healthcare system, this partnership combines both companiesโ€™ unique expertise to advance pharmacistsโ€™ up-to-date knowledge and provide them with science-based information that allows them to strengthen value-based relationships with their customers.

Agilent to Collaborate with Quest Diagnostics to Extend Access to the Agilent Resolution ctDx FIRST Liquid Biopsy Test

Baxter Announces Exclusive Distribution Agreement with bioMerieux for Novel Acute Kidney Injury Diagnostic Test in Europe and U.S.

Agilent Technologies Inc., announced an agreement with Quest Diagnostics , the worldโ€™s leading provider of diagnostic information services. The alliance will enable providers and patients throughout the United States to access the Agilent Resolution ctDx FIRST liquid biopsy next-generation sequencing (NGS) test. Healthcare providers can order the test beginning today.

The agreement between Quest and Agilent will enable broad adoption for ctDx FIRST, a single-site premarket approved (ssPMA) test performed at the Resolution Bioscience CLIA laboratory in Kirkland, Washington. ctDx FIRST is the first liquid biopsy test approved by the U.S. Food and Drug Administration (FDA) as a companion diagnostic (CDx) to identify advanced non-small cell lung cancer (NSCLC) patients who may benefit from treatment with KRAZATITM. KRAZATI (adagrasib) received accelerated approval as a targeted treatment option for adult patients with KRASG12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy. ctDx FIRST is also FDA-approved for tumor profiling of the epidermal growth factor receptor (EGFR) gene in accordance with professional guidelines in oncology for patients with advanced non-small cell lung cancer (NSCLC).

As a professional service, the ctDx FIRST test report* includes comprehensive genomic profiling on 109 genes across four types of alterations: single nucleotide variants, indels, copy number amplifications, and fusions.

โ€œWe are looking forward to the Quest Diagnostics alliance facilitating broad access to ctDx FIRST, our liquid biopsy solution,โ€ said Paul Beresford, vice president and general manager of Agilentโ€™s Companion Diagnostics Division. โ€œThis expands the testing options available for NSCLC patients as patients donโ€™t always have tissue available for molecular analysis.โ€

“The addition of the ctDx FIRST test to our oncology menu underscores our commitment to providing access to precision medicine innovations to improve care for patients with cancer,” said Kristie Dolan, vice president and general manager, Oncology Franchise, at Quest Diagnostics. “It also reflects our ability to optimize our national physician and patient access network to extend access to important medical innovations with the potential to improve patient outcomes.”

Under the terms of the agreement, Quest will offer ctDx FIRST to healthcare providers in the United States seeking a minimally invasive liquid biopsy test option as a CDx for KRAZATI. Healthcare providers can order the test electronically through the Quest connectivity platform, which connects to hundreds of electronic medical records (EMRs). Healthcare providers may direct patients to provide specimens at one of Questโ€™s 2,100 patient service centers across the United States. Integrating Questโ€™s electronic health record (EHR) platform and access to its national patient center network will make it easier for healthcare providers to incorporate ctDx FIRST as part of regular clinical care.

 

 

Strados Labs Forms Collaboration with Boehringer Ingelheim for its IPF Pilot Study

Strados Labs Forms Collaboration with Boehringer Ingelheim for its IPF Pilot Study

Strados Labs announced a collaboration with Boehringer Ingelheim to remotely monitor patients using its FDA-cleared pulmonary wearable device in an upcoming idiopathic pulmonary fibrosis (IPF) pilot study. In Boehringer Ingelheimโ€™s pilot study, the Strados RESP Biosensor will be used to monitor cough and crackles in IPF patients at home aiming to accelerate the development of much needed new therapies for people living with IPF.

Research has suggested that cough may be associated with worse outcomes in pulmonary fibrosis. Boehringer Ingelheim will assess how monitoring cough and crackles with the RESP Biosensor can be used to monitor the status of patients with this disease, with the aim of advancing clinical research and the development of next therapies to transform the lives of people with pulmonary fibrosis.

โ€œCurrently, disease progression in IPF is measured by a decline in forced vital capacity (FVC).โ€ Says Strados Labs CEO & Cofounder Nick Delmonico. โ€œWe are thrilled to help Boehringer Ingelheim explore cough and crackles as an additional method to monitor disease while allowing patients to stay in the comfort of their homes.โ€

The RESP Biosensor is a lightweight, non-invasive wearable device that is used in clinical trials to monitor cough frequency, severity, and type along with wheezing and other abnormal sounds. The device is also used for remote monitoring in healthcare to address the problem of patient readmissions associated with COPD, asthma, and other cardiopulmonary diseases.

 

 

Blackford and Brainomix Announce AI Partnership for Stroke Care

State of Artificial Intelligence in the Healthcare Industry revealed through a new IDC White Paper

Blackford, the pioneering strategic imaging AI platform and solutions provider, and Brainomix, the AI-powered medtech solutions company, have announced a strategic partnership to bring Brainomixโ€™s comprehensiveย e-Strokeย solution to the Blackford Platform, making advanced stroke care available to more institutions around the world.

According to the World Stroke Organization, there are over 12.2 million new strokes each year. In more rural areas, access to advanced imaging may be limited, which can have a negative impact on stroke diagnosis and treatment. Brainomixโ€™sย e-Strokeย AI tools can generate real-time interpretation of more widely available non-contrast CT exams, expanding access to life-saving stroke treatments.

“Timely diagnosis and treatment of stroke should not be limited to urban areas and comprehensive stroke centers,โ€ said Blackford Founder and CEO Ben Panter. โ€œAdding Brainomixโ€™s AI-poweredย e-Strokeย to the Blackford Platform allows more institutions around the world to accelerate transfer and treatment times and expand access to critical endovascular therapy for their patients.โ€

Brainomixโ€™s AI-poweredย e-Strokeย tools can utilize images from non-contrast or contrast enhanced CT exams to provide physicians fast, effective, and accurate analysis of images that expedite treatment decisions. Combined with theย e-Stroke Mobileย app, physicians can quickly and securely access, review, and share patient images and data to optimize workflow and facilitate faster transfer and treatment decisions.

โ€œWe are very excited to launch this partnership with Blackford โ€“ a company that has firmly established itself as a leading provider of tailored best-in-class medical imaging and AI-powered solutions that deliver clinical value, with an extensive customer base and a highly regarded focus on technical excellence,โ€ said Dr Michalis Papadakis, CEO & co-founder at Brainomix. โ€œWith our e-Stroke platform, we believe that we have the opportunity to work together to provide physicians with the most comprehensive stroke AI imaging solution, shown to optimize networks and ultimately improve patient outcomes.โ€

Sysnav Healthcare Announces a Multi-Year Collaboration with Roche

Sysnav Healthcare Announces a Multi-Year Collaboration with Roche

Sysnav Healthcare has developed medical grade wearables based on magneto-inertial technology for 3D movement reconstruction. This enables precise movement tracking without GPS, thus protecting patient privacy while enabling indoor monitoring.

Sysnav Healthcare and Roche have expanded their collaboration across multiple programs to develop meaningful digital endpoints that will monitor disease progression, support clinical trials and serve as regulatory approved standards of outcome measurement. The partnership will also develop the next generation wearable technology to further promote personalised healthcare.

“When high precision technology meets clinical expertise, it is a game-changing combination to accelerate medical progress. Bringing together Sysnav’s digital health technology and Roche’s expertise in neuroscience drug development and personalised healthcare will enable us to have a truly meaningful impact on patients with motor impairments. By establishing a new set of industry standards for the evaluation of motor impairments, we can unlock innovation for the benefit of all patients,” says Damien Eggenspieler, Sysnav Healthcare Program Director.

 

Imricor Collaborates with GE HealthCare in Interventional Cardiac MRI

GE Healthcare's Stress Agent Rapiscan Approved for use in Stress Cardiac Magnetic Resonance Imaging

Imricor Medical Systems, Inc. Imricor, the global leader in real-time interventional cardiac magnetic resonance (iCMR) ablation products, is pleased to announce that it has entered into a Memorandum of Understanding (MOU) with GE HealthCare.

Under the terms of the MOU, GE HealthCare and Imricor intend to collaborate to interface Imricorโ€™s Advantage-MR EP Recorder/Stimulator and Northstar-MR 3D Mapping System with GE HealthCare MRI scanners. A successful collaboration will enable cardiac electrophysiology (EP) ablation procedures guided by real-time MRI, using Imricorโ€™s catheters and other disposable devices, to be performed on the GE HealthCare MRI platform. The collaboration with GE HealthCare would expand Imricorโ€™s potential to interface with GE HealthCareโ€™s new and currently installed MRI scanners.

Imricorโ€™s short-term goal is to allow sites with GE HealthCare MRI systems to participate in the upcoming โ€œVision-MRย Ablation ofย Atrialย FLutterโ€ or VISABL-AFL clinical trial in the US and โ€œVision-MRย Ablation ofย Ventricularย Tachycardiaโ€ or VISABL-VT clinical trial in Europe. The Companyโ€™s overall goal is to broaden in the choices physicians and hospitals have when choosing an MRI platform for their iCMR labs.

โ€œImricorโ€™s innovative technology has the potential to bring significant benefit to a large number of cardiac arrhythmia patients,โ€ said Anja Brau, PhD, General Manager, GE HealthCare MR Clinical Solutions and Research Collaborations. โ€œGE HealthCare has a long-standing history of applying MR to therapy guidance and control; we would be pleased to add Imricorโ€™s capabilities to provide our customers with more options to treat their patients.โ€

โ€œWe are thrilled at the prospect of expanding the portfolio of MRI scanners that support Advantage-MR and Northstar-MR technology,โ€ said Steve Wedan, Imricorโ€™s CEO and Chair. โ€œThe addition of GE HealthCare will give physicians and hospitals significantly more flexibility to use the MRI hardware of their choice, when providing real-time iCMR ablations for their patients. We are grateful to our existing customers who have embraced our real-time iCMR ablation technology, and look forward to making the benefits of this technology even more widely available.โ€

Masimo Announces the Limited Market Release of Visual Clinical Activity Monitoring

Masimo Announces the Limited Market Release of Visual Clinical Activity Monitoring

Masimo announced the limited market release of Visual Clinical Activity Monitoring, a video analysis system that uses artificial intelligence to help facilitate compliance with hospital hand hygiene protocols. VCAM, which integrates seamlessly with the Masimo Hospital Automationโ„ข platform of solutions, including Masimo Patient SafetyNetโ„ข, Replicaยฎ, and Rootยฎ, is designed to help hospitals and other care facilities optimize protocol adherence, with real-time notifications at the point-of-care about current hand hygiene status and powerful analytics around protocol compliance โ€“ with the ultimate goal of helping institutions decrease the incidence of hospital-acquired infections (HAIs).

Hand hygiene is well known to be an important factor in infection control activities, with numerous studies showing that washing oneโ€™s hands is the โ€œsingle most important, simplest, and least expensive means of reducing the prevalence of HAIs and the spread of antimicrobial resistance.โ€1 A recently published study conducted across multiple sites over eight years in Finland, for example, found a direct correlation between increased compliance with hand hygiene protocols and decreased incidence of HAIs.2 However, in the absence of โ€œactiveโ€ hand hygiene initiatives โ€“ programs, for example, designed to measure and automate compliance โ€“ the compliance rate with such protocols rarely exceeds 40% in hospitals and other healthcare institutions.1

Masimo VCAM, powered by Masimoโ€™s expertise in AI-enabled algorithms and based on each facilityโ€™s standards, makes it easier for hospitals to optimize staff adherence to hand hygiene protocols by providing notifications on the spot, tracking compliance, and automating reporting. VCAM detects when clinicians are performing hygiene activities, such as washing hands or using an alcohol-based sanitizer, and identifies when they interact with people and objects, as well as when they touch or pick up an object from a potentially unclean surface such as the floor. Immediate notifications about current hygiene status are relayed to individual clinicians on bedside Root monitors and on Replica-equipped smartphones, prompting them, for example, to wash or sanitize their hands when they may have neglected to do so. In turn, VCAMโ€™s rich reporting capabilities provide detailed analysis, such as the rates of clean vs. dirty incidents (which can be filtered by room and by department), helping leadership target opportunities for workflow improvements.

Vijay Dhar, MD, Chief of Neonatology at Childrenโ€™s Hospital of Orange County (CHOC), California, said, โ€œWe, at CHOC, are eagerly anticipating the deployment of Masimo VCAM, the innovative artificial intelligence (AI) system that can characterize hand hygiene compliance. We hope VCAM will be able to help us to decrease hospital-acquired infections (HAIs), including viral pathogens such as respiratory syncytial virus (RSV), bacterial organisms such as MRSA, and other nosocomial organisms responsible for central line associated blood stream infections (CLABSI), the most common form of nosocomial infection affecting neonates. With Masimo VCAM helping us maintain hand hygiene, we aim to diminish these totally preventable HAIs and improve the safety and wellbeing of our neonates.โ€

Joe Kiani, Founder and CEO of Masimo, said, โ€œVCAM adds an important new tool to the growing Masimo ecosystem of Hospital Automation products, building on our experience developing breakthrough algorithms and next-generation connectivity solutions, to help streamline hospitalsโ€™ ability to meet compliance goals with as fundamental and critical a task as hand-washing. VCAM aligns with our continued mission to improve patient outcomes, reduce the cost of care, and ultimately, improve life.โ€

 

ClariMed, Inc Launches Integrated Medical Device Services Partner

ClariMed, Inc., announced the launch of the first MedTech services partner to take an integrated, human-centric approach to medical product development.ย  The Company also announced the acquisition of San Jose-based UserWise, LLC, and the appointment of Kelley Kendle as Chief Executive Officer and Chair of the Board of Directors.ย  The Company was formed in partnership with NaviMed Capital, a private investment firm focused exclusively on the healthcare industry.

ClariMed was formed to meet the MedTech industryโ€™s growing need for an integrated partner focused on development and regulatory services.ย  ClariMed embraces a human-centric approach to the MedTech product lifecycle, taking an integrated approach that differs from the current fragmented support ecosystem that sponsors face when bringing products to market and meeting regulatory requirements. With the increasing variety in users of medical products and growing regulatory requirements, MedTech innovators are struggling to find partners who can understand, coordinate, and meet the emerging requirements for human-centric product design and development.

Today, sponsors must go to multiple vendors and coordinate these very complex efforts themselves, requiring time and resources while sacrificing continuity and an integrated approach. ClariMed aims to address this unmet need by integrating best-of-breed services partners across product design, engineering, and development services in a cross-disciplinary approach that embeds human factors and regulatory disciplines at its core.

The ClariMed team brings an essential understanding of user needs and abilities within the context of their environments and systems that spans the entire product lifecycle, ensuring the right risk-benefit balance.

ClariMedโ€™s goal is to provide sponsors with a clear path to market, accelerate that path through iterative formative steps and scalable development services, and ensure risk mitigation through an integrated approach.ย  ย This accelerated approach enables greater efficiency and leads to better regulatory, marketability, and usability outcomes.

With the appointment of Kelley Kendle as CEO and Board Chair, ClariMed is led by an executive with a wealth of experience in service-based businesses targeting medical device and pharmaceutical companies. She previously held executive positions as President and CEO of Synchrogenix (a subsidiary of Certara), as Chief Solutions Officer of Certara, a pharma-focused strategic regulatory services business, and as CEO of a European Medical Device CRO.

Kelley Kendle, CEO and Board Chair, commented:

โ€œEvolving FDA regulations and the EU Medical Device Regulation (MDR) are motivating medical product sponsors to continue their focus on risk mitigation. These sponsors need a strategic partner with a differentiated platform of services to guide them through development milestones while maintaining a constant awareness of evolving agency expectations. The ClariMed team will help our clients balance risk-benefit and get a usable product to the market faster. We will bring together experienced firms with differentiated services to provide a comprehensive offering and a multi-regional footprint. I look forward to building a team that will have such a significant impact on peopleโ€™s lives.โ€

ClariMed was formed in partnership with NaviMed Capital, a healthcare-focused investor.ย  โ€œRecognizing the significant need from MedTech sponsors for an agile, services-focused partner, NaviMed is proud to partner with Kelley Kendle and the ClariMed team,โ€ said Josh Boylan, ClariMed Board Member and Vice President at NaviMed Capital.

UserWise, based in San Jose, is the leading independent human factors provider. Offering human factors and usability engineering services, usability study recruitment, market research/simulation facilities, and IRB services, UserWise has built a reputation as a thought leader in the human factors space.ย  ClariMedโ€™s acquisition of UserWise is an exciting step as ClariMed builds on its human-centric approach to the MedTech product lifecycle.

Shannon Clark, Founder & CEO at UserWise, commented:

โ€œWe have attracted the best and brightest of next-generation human factors engineers and participant recruiters as we focus on building a world-class organization. We are experts in human factors for medical product development and leverage our individual experiences, which range from Fortune 500 medical product companies to leading start-ups, to empathize with in-house innovators to work seamlessly with their teams. This broader perspective that human factors is a small piece in a greater puzzle is the key to developing successful, usable medical products.ย  We are excited to have the backing of ClariMed as we continue to pursue our common goals of maximizing the health, well-being, and safety of medical product patients and users.โ€

โ€œWe are excited to partner with UserWise, given the breadth of their expertise across medical products, including robotic surgery, home-use products, combination devices, and more,โ€ said Brian Canann, ClariMed Board Member and Managing Director at NaviMed Capital.

 

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