Connect with us

Technology

Lindus Health Launches Bespoke “All-in-One Medical Device CRO” Offering for Medical Device Clinical Trials

Published

on

NEW YORK, June 27, 2024 /PRNewswire/ — Lindus Health, the “anti-CRO” running radically faster, more reliable clinical trials for life science pioneers, has unveiled their all-encompassing contract research organization (CRO) and technology solution customized for the execution of medical device clinical trials.

Lindus Health has enrolled over 11,000 medical device trial participants to date in the US, UK, and Europe, and has demonstrated consistent success in executing device studies across virtually all therapeutic areas, including neurology, ophthalmology, cardiovascular, respiratory, and more. This covers many device types including Class I (low-risk) and Class II (moderate-risk) devices, diagnostics and others, as well as regulatory pathways such as premarket approval (PMA) and Conformité Européenne (CE) marking. With the introduction of their “All-in-One Medical Device CRO,” Lindus will accelerate and enhance clinical trials for medical devices, pulling from their robust resume in device development.

Lindus Health’s new offering integrates traditional CRO services and comprehensive experience in medical device clinical trials. Additionally, they have unique recruitment capabilities by utilizing their database of over 30 million electronic health records (EHRs) and or in-house digital marketing. This offering also includes their home-grown eClinical technology, Citrus™. Lindus offers extensive in-house site capabilities including their own virtual/hybrid site and physical community site networks. This all-inclusive package equips medical device sponsors with all the necessary tools to run their studies under one roof.

Medical device clinical trials follow distinct regulatory pathways and often require extensive post-market surveillance and reporting. Lindus Health’s offering leverages their expertise in FDA 510(k) and De Novo submissions and participant monitoring in device trials alongside their virtual and traditional site capabilities, multi-channel recruitment approaches, and more. Their tech-driven approaches to nearly all facets of medical device trial execution enable them to achieve study milestones quicker and enroll participants twice as fast as traditional CROs.

“Device trials are highly unique in the endpoints they measure, the level of support that may be needed to educate participants on the investigational device, shipping and storage considerations, and much more,” said Anthony Brogno, Director of Clinical Operations at Lindus Health. “Whether it’s a decentralized or site-based study, our ‘All-in-One Medical Device CRO’ allows us to help sponsors navigate the specialized demands of these trials at every stage while prioritizing patient experience.”

The “All-in-One Medical Device CRO” offering provides medical device companies with an exhaustive suite of features:

End-to-end CRO and study management: From startup through close-out, Lindus Health’s clinical operations team handles all project-related and administrative medical device study activities.Innovative recruitment tactics: Lindus’ multifaceted approach to recruitment involving primary care collaboration, screening from a network of over 30 million EHRs, digital marketing capabilities and more help medical device sponsors quickly meet enrollment timelines.Study-specific eClinical software: Citrus™, Lindus Health’s proprietary trial execution technology, houses all the necessary tools needed to run medical device research in one place, including the Clinical Trial Management System (CTMS), Electronic Data Capture (EDC), patient scheduling, eConsent, IRT/randomization, and more, tailored to each individual study.Medical device and regulatory expertise: The Lindus Health team, including its advisors, offer expert insights in medical device trial operations including deep knowledge of regulatory frameworks and staying current with industry trends.Dedicated site services: Lindus’ site operations team maintains strong rapport with principal investigators (PIs) and research staff to effectively manage clinical trials of various models, including single-site or multi-site and virtual/hybrid or traditional.

“Working with the Lindus Health team has been a game changer,” said Akash Bijalani, Director of Global Market Access at Aptar, a global leader in medical technologies. “They have a can-do attitude and make things happen, going above and beyond the call of duty.”

Lindus Health’s “All-in-One Medical Device CRO” is bolstered by the support of their advisory board, including Robert Langer, co-founder of Moderna, and other medical device industry experts such as Acacia Parks, Chris Butler, Peter Polos, Jason Bain, and David Stempel.

Lindus Health is passionate about helping sponsors bring innovative medical devices to market by streamlining all variables of the clinical research process while ensuring stellar trial experiences for both sponsors and participants.

To learn more about Lindus Health’s “All-in-One Medical Device CRO,” click here.

About Lindus Health
Lindus Health is an anti-CRO running radically faster and more reliable 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 30 million Electronic Health Records.

Clinical trials are the biggest bottleneck to advances in healthcare. Lindus Health removes this constraint by handling the end-to-end execution of clinical studies, including design, patient recruitment, clinical data capture, monitoring and project management.

To date, Lindus Health has delivered more than 90 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 $24M from investors including Peter Thiel, CREANDUM, Firstminute Capital, Presight Capital, Seedcamp, Hambro Perks, Amino Collective and Calm/Storm.

Lindus Health Media Contact:
Jodi Perkins
Amendola for Lindus Health
jperkins@acmarketingpr.com 

 

View original content to download multimedia:https://www.prnewswire.com/news-releases/lindus-health-launches-bespoke-all-in-one-medical-device-cro-offering-for-medical-device-clinical-trials-302184163.html

SOURCE Lindus Health

Continue Reading
Click to comment

Leave a Reply

Your email address will not be published. Required fields are marked *

Technology

Alogent Receives Federal Reserve Authorization to Directly Exchange X9 Check Image Files for Banks and Credit Unions, Expanding its Role as a Payments Infrastructure Provider

Published

on

By

PEACHTREE CORNERS, Ga., April 21, 2026 /PRNewswire/ — Alogent (@AlogentCorp), a global software leader in the banking and financial services market, announced it has been authorized by the Federal Reserve to send and receive X9 check image exchange files on behalf of its financial institution clients, enabling end-to-end check presentment and returns without the need for intermediary processors.

This direct connectivity allows banks and credit unions to consolidate capture, processing, clearing, settlement, and returns within a single, integrated Alogent platform, delivering faster processing, simpler integrations, fewer vendors, and greater operational control.

“Becoming authorized by the Federal Reserve to directly exchange X9 files for both outbound presentment and inbound returns marks a fundamental shift in Alogent’s role in the payments ecosystem,” said Dede Wakefield, CEO of Alogent. “By removing third‑party intermediaries, we’re repositioning Alogent as a core infrastructure provider, giving banks and credit unions a more direct path to the Fed, and a strong foundation as payments continue to modernize toward consolidation and real‑time settlement.”

Key Benefits for Banks and Credit Unions Include:

Direct exchange of X9 check presentment and return files with the Federal Reserve, without intermediary processorsFaster clearing and settlement times for check image exchangeEnd-to-end visibility across forward presentment and returns workflowsSimplified technology integrations and reduced vendor sprawlGreater operational control and transparency across payment workflowsA future‑ready foundation for real‑time and next‑generation Fed services

“This authorization translates our product strategy into tangible operational benefits for banks and credit unions,” said Ashish Bhatia, VP of Product Management at Alogent. “By consolidating critical payment workflows within a single platform, institutions gain simpler operations, stronger oversight, and sustained control.”

As adoption of faster payments and modern settlement models accelerates, Alogent’s direct Federal Reserve connectivity positions both the company and its clients at the center of the evolving U.S. payments infrastructure, while establishing a foundation for potential direct connectivity to additional Federal Reserve services, including FedNow® real‑time payments, Fedwire®, FedACH®, and FedLine®. This authorization places Alogent among a limited group of technology providers trusted to directly exchange check image files with the Federal Reserve on behalf of financial institutions.

About Alogent

Alogent provides proven, end-to-end check payment processing, and enterprise content, information, and loan management platforms, to financial institutions of all sizes, including credit unions, community banks, and some of the largest national and international institutions. Our unique approach spans the entire transaction ecosystem — capturing and digitizing transaction data, exception tracking, and automating entire transaction and loan management workflows so that information is available across the enterprise. Alogent’s solution suites leverage the latest in machine learning and predictive analytics, including enterprise-wide data intelligence and reporting solutions that enable financial institutions to deliver products and services that boost engagement through personalization and data-backed decisions. Learn more about Alogent at www.alogent.com.

View original content to download multimedia:https://www.prnewswire.com/news-releases/alogent-receives-federal-reserve-authorization-to-directly-exchange-x9-check-image-files-for-banks-and-credit-unions-expanding-its-role-as-a-payments-infrastructure-provider-302746616.html

SOURCE Alogent

Continue Reading

Technology

yieldWerx and Enlight Technology Extend Design-to-Test Data Continuity Across Taiwan’s Semiconductor Ecosystem

Published

on

By

HSINCHU, Taiwan, April 21, 2026 /PRNewswire/ — yieldWerx is expanding its presence in Taiwan through a collaboration with Enlight Technology Co., Ltd., bringing advanced test data aggregation and analysis capabilities to one of the world’s most concentrated semiconductor markets.

The collaboration combines Enlight Technology’s established role across Taiwan’s semiconductor design, manufacturing, and research landscape with yieldWerx’s expertise in data aggregation and statistical analysis. Together, the companies aim to address the increasing demand for data-driven yield optimization as device complexity grows across advanced packaging, silicon photonics, and heterogeneous integration.

Enlight Technology is the authorized representative of Siemens EDA in Taiwan and provides a portfolio of electronic design automation (EDA), manufacturing execution systems (MES), and engineering solutions spanning IC, silicon photonics, MEMS, PCB, and system-level applications. The company supports semiconductor and electronics customers, including fabless design houses, foundries, OSATs, and system companies, with engagement across more than 100 semiconductor organizations and 300 system companies in the region.

As part of the partnership, the companies will work together to:

Provide localized technical engagement and support aligned with Taiwan’s semiconductor workflows and language requirements.Support improved yield learning cycles and more efficient production ramp across the region.Extend yield analytics capabilities into an ecosystem spanning design, verification, and manufacturing execution.

“We are excited to partner with Enlight Technology as we expand into Taiwan and the broader Asian market. Their deep domain expertise and strong ecosystem presence significantly enhance our ability to deliver scalable, data-driven yield solutions to customers operating at the forefront of semiconductor innovation.” — Aftkhar Aslam, CEO, yieldWerx

“As advanced packaging and silicon photonics drive exponential test data growth, our partnership with yieldWerx equips Taiwan’s ecosystem with powerful statistical analysis. We empower customers to turn complex data into actionable insights, accelerating yield learning and time-to-market” — Su Cheng Yu, General Manager, Enlight Technology

About yieldWerx
yieldWerx is a leading data and yield analytics platform for semiconductor manufacturing, advanced packaging, and photonics I/O. The platform provides end-to-end visibility across wafer probe, optical and electrical wafer acceptance, module assembly, and system-level test. By analyzing this data, yieldWerx helps organizations understand yield performance, variability, and production trends, enabling optimized quality and faster time-to-market.

About Enlight Technology Co., Ltd.
Enlight Technology Co., Ltd. is a Taiwan-based provider of electronic design automation and engineering solutions and serves as the authorized representative of Siemens EDA in Taiwan. The company delivers solutions spanning IC, silicon photonics, MEMS, PCB, DFM, and manufacturing execution systems, supporting customers from IC-level design to system-level integration. With over three decades of experience, Enlight Technology provides customized solutions and technical services to the electronics industry.

For further information, please visit https://www.yieldWerx.com or https://www.enlight-tec.com/.

Company contacts:

yieldWerx
Tina Shimizu
Chief Marketing Director
412529@email4pr.com
+1 888-929-4022

Enlight Technology Co., Ltd.
Jamie Su
Marketing Director
412529@email4pr.com 

View original content to download multimedia:https://www.prnewswire.com/news-releases/yieldwerx-and-enlight-technology-extend-design-to-test-data-continuity-across-taiwans-semiconductor-ecosystem-302748158.html

SOURCE yieldWerx

Continue Reading

Technology

Former UK SAS Sargeant Joins Delta Three Oscar to Drive Awareness of Next-Generation Military Protection

Published

on

By

BLACKSBURG, Va., April 21, 2026 /PRNewswire/ — Delta Three Oscar, the military and ballistic protection division of D3O, today announces former UK Special Forces veteran and expedition leader Jay Morton as its first-ever brand ambassador.

 

Morton will bring his military expertise to Delta Three Oscar and will be endorsing the company’s latest impact protection and shock absorbing footwear whilst providing experience backed insights to the team as part of the company’s ongoing innovation into protective equipment.

The partnership is a strategic move for the protection brand to increase awareness and the benefits of its impact and shock absorbing personal protection systems amongst end users. Delta Three Oscar engineers the most advanced ballistic helmet liners, impact protection body armour, and shock absorbing midsoles used in helmets, uniforms, chest plates and footwear worn by U.S. military, NATO forces and law enforcement departments worldwide. The body armour is lightweight, flexible and designed to reduce fatigue by ensuring a comfortable fit with unrivalled impact protection, tough enough to be used in the harshest environments.

Morton served 14 years in the British Armed Forces, including four years in the Parachute Regiment and ten years with the Special Air Service, touring the Afghanistan and Iraq on multiple occasions. His frontline experience and expertise in high-risk environments give him huge credibility to endorse Delta Three Oscar’s next-generation protection designed for elite performance, enhanced comfort, and impact reduction.

Now as an elite expedition leader, Morton has highlighted the importance of trust, comfort, and reliability in protective gear.

“Trust in your protective equipment is absolutely essential,” he said. “When you’re operating in high-risk environments, comfort and reliability are paramount and you can’t afford distractions. Delta Three Oscar’s body and limb protectors deliver exceptional impact and ballistic performance while remaining incredibly comfortable. It’s ‘fit and forget’ protection that allows operators to focus entirely on the mission.”

Delta Three Oscar engineers advanced protection technologies including:

Ballistic body armour protection materials to mitigate back face deformationHALO® helmet suspension systems available in 3, 7 and 9 pad configurationsImpact protection flexible moulded armour for knees and elbows including tough outer shellsUnderfoot shock-absorbing protection used in midsoles

These products and materials are engineered to reduce fatigue, improve comfort, and enhance operational effectiveness in demanding environments.

“Jay brings a huge amount of credibility and real operational insight into what frontline personnel require from their protective equipment,” said Mostyn Thomas, Chief Marketing Officer at Delta Three Oscar. “His experience at the highest level of military performance makes him an ideal partner as we continue advancing protection technology and supporting those who serve, giving them a subconscious advantage by knowing they have the best protection available”

As Delta Three Oscar’s first ambassador, Morton will feature in the company’s latest brand campaign highlighting the benefits of Delta Three Oscar’s unique military protection innovation and performance.

Media Contact:
Serena Thynne
09178533121
412519@email4pr.com

View original content to download multimedia:https://www.prnewswire.com/news-releases/former-uk-sas-sargeant-joins-delta-three-oscar-to-drive-awareness-of-next-generation-military-protection-302748124.html

SOURCE D3O

Continue Reading

Trending