R.R. Donnelley & Sons Company (RRD), a leading global provider of marketing, packaging, print, and supply chain solutions, announced the extended portfolio of end-to-end services to support at-home testing. These services enable diagnostic device, at-home healthcare, health insurance, and point-of-care testing companies in their efforts to keep pace with the evolution of healthcare.

As the pandemic disrupted supply chains, it also shifted consumer preferences and accelerated adoption of at-home and digital healthcare. For many test manufacturers and healthcare companies, a number of challenges (e.g., labor constraints, infrastructure limitations, inventory visibility, supply irregularity, compliance, complex IT requirements, etc.) continue to stand in the way of bringing innovative new products and solutions to market.

Identifying an opportunity to provide greater support, RRD solidified its end-to-end offering that integrates and advances the regulated kitting, production, and fulfillment workstream. This solution includes a strategic alignment of the following RRD services:

• Packaging and labeling solutions — structural engineering, folding cartons, rigid boxes, branded corrugated, prototyping and testing, labels, instructions for use
• Sourcing and supply chain — component procurement, configuration and assembly, track and trace
• Fulfillment services — direct-to-patient compliant ordering, warehousing, fulfillment
• Creative and Professional Services — graphic design, kit ideation, and technology integration (Web and API)

RRD’s global network includes regulatory-compliant facilities, from FDA registration and ISO accreditation through cGMP compliance and SOC/SOC2+ for direct-to-consumer fulfillment. The company’s expertise is built on nearly two decades of experience producing and kitting diagnostic and medical kits.

“There has been significant innovation and advancement in the diagnostic test kits market in recent years, and we’re now seeing increased availability of rapid testing in new categories, such as diabetes, fertility, and sexually transmitted infections,” said John Pecaric, Head of Operations at RRD. “The pandemic accelerated the emergence of diagnostic testing for point-of-care and at-home, driving the need for increased accuracy and reliability.”

Pecaric adds, “Thanks to existing global resources and decades of experience in the life sciences sector, our organization is well positioned to help clients reimagine the care experience and take their products to market without compromise. RRD has the automation capabilities, capacity, and accreditations to help clients scale operations and manage the complexity of telehealth, virtual care platforms, and health insurance requirements.”

RRD has longstanding relationships with a number of medical device providers, including Siemens Healthineers. When the FDA approved the rapid COVID-19 antigen self-test, Siemens Healthineers collaborated with RRD for the inbound receipt, inspection, warehousing, labeling, fulfillment, and logistics of the tests. RRD leveraged its supply chain expertise and ability to scale quickly to facilitate the time-sensitive project.

An event that hasn’t happened before was demonstrated by researchers from Duke-NUS Medical School, colleagues in Germany, and the National Heart Centre Singapore (NHCS), suggesting that regenerative treatment to restore damaged kidney function could be a sure possibility. In a preclinical study, the researchers discovered that suppressing the harmful and scar-regulating protein interleukin-11 (IL-11) allowed the damaged kidney cells to recover, restoring reduced kidney function caused by illness as well as acute injuries.

The protein is involved in pushing a cascade of molecular processes that occur in response to kidney damage, resulting in inflammation, fibrosis, also known as scarring, and loss of function. In addition, they discovered that blocking IL-11 with a neutralising antibody can halt and even restore kidney damage in this situation.

More precisely, the researchers discovered that in reaction to kidney damage, renal tubular cells, which line the tiny tubes within the kidneys, release IL-11. It initiates a signaling cascade that results in increased activation of a gene known as Snail Family Transcriptional Repressor 1 (SNAI1), which inhibits cell growth and increases the possibility of kidney misfunctioning.

Turning off this method in a preclinical model of human diabetic kidney disease by way of administering an antibody that binds to IL-11 resulted in the proliferation of kidney tubule cells and the reversal of fibrosis as well as inflammation, making way for the regeneration of the injured kidney and also the restoration of renal function.

While clinical trials pertaining to an antibody that attaches to another pro-fibrotic molecule known as transforming growth factor-beta were unsuccessful, this novel technique offers the possibility of a new target.

Consultant Orthopaedic Oncologist and Honorary Senior Lecturer at the Newcastle University, Dr. Kenneth Rankin has decided to reunite with his fellow specialists across the Netherlands, UK, Japan, Canada, and USA to push new surgical treatment technologies in cases of bone tumours. An upcoming clinical trial that is going to be led by Dr. Rankin and assisted by the Bone Cancer Research Trust will study the effectiveness of a dye known as Indocyanine Green, or ICG, which can be given to patients before their surgery and thereby leads to the tumour fluorescing green.

The trial has plans to recruit 500 patients so as to test if the use of ICG in the fluorescence guided surgery can aid in identifying the tumour, help in an absolute removal and also reduce the healthy tissue amount be reduced. An expert research group has agreed that this type of guided surgery can lead to a significant level of patient benefit when it comes to reducing local recurrences as well as the surgery’s effects. That said, collaborative research is the need of the hour in this area, and the combined efforts and expertise will lead to researchers speeding up the introduction of patient care technologies.

Dr. Rankin, who is also a part of the Newcastle Hospital Trust, adds that they are indeed excited to highlight the fact that the cancer surgery technology is developing at a rapid pace, and with the funding from a trust as big as Bone Cancer Research, they will be working along with surgeons, scientists, as well as pathologists from across the world in order to test new techniques so as to elevate cancer operations for the bone sarcoma patients. This is bound to have an impact over the long term for patients suffering from different cancer types.

Fluorescence guided surgery happens to be an innovative technique which makes use of the light emission to get to know the tumours precise location and also boundaries at the time of a surgical removal. It enhances the surgeon’s capacity to successfully remove the whole tumour and decreases the probability of any cancer cells remaining. The consortium is all set to bring together researchers from across the world who are working towards improving tumour removal by way of surgery while at the same time limiting its impact on the patient’s functionality as well as quality of life.

Ethicon, a Johnson & Johnson MedTech company, today announced the first robotic-assisted removal of kidney stones using the Monarch platform.

Auris Health, an Ethicon subsidiary, received FDA clearance for Monarch for endourological procedures in May 2022. The University of California, Irvine’s UCI Health used the Monarch platform for urology to complete the first procedure.

According to a news release, it’s the first successful robotically assisted, electromagnetic-guided percutaneous access and mini-percutaneous nephrolithotomy procedure. Ethicon said its study involves a collaboration with co-investigator Dr. Mihir Desai from the University of Southern California.

“This clinical study is the first in the world to research and demonstrate the potential for improved navigation, access, clearance and control in mini-PCNL procedures using the Monarch platform for urology,” said Dr. Jaime Landman, chair of the UCI School of Medicine Department of Urology and director of the UCI Health Kidney Stone & Kidney Disease Services. “In addition to potentially helping urologists achieve stone-free patients in a single procedure, this approach could help reduce the need for retreatment after kidney stone removal and decrease risks and complication rates.”

Ethicon’s clinical group led the first case in its clinical study. It aims to collect performance data on robotic mini-PCNL procedures to optimize Monarch and inform training and education.

“The prevalence of kidney stones remains high, and many urologists seek a new treatment option that reduces overall retreatment and complication rates,” Desai said. “In patients who require treatment through surgery, close to one in two will require retreatment within five years.”

Philips is an active participant in the new European Union (EU) European Federation for Cancer Images consortium (EUCAIM) – a cornerstone project in the European Cancer Imaging Initiative that was launched by the European Commission in the run-up to World Cancer Day 2023. Addressing the need for researchers and innovators to access real-world oncology data at the scale and quality needed to develop new solutions to help detect, diagnose and treat cancer, notably those based on artificial intelligence (AI), the European Cancer Imaging Initiative will work towards creating a digital infrastructure that links up resources and databases of cancer imaging data across the EU, while ensuring adherence to high standards of ethics, trust, security, and data protection.

Within the Cancer Imaging Initiative, the EUCAIM project will focus on designing and deploying a federated infrastructure for cancer imaging data, with the resultant atlas of cancer imaging repositories made available to the initiative‘s second cornerstone project – the AI Testing and Experimentation Facility for Health (TEF-Health). TEF-Health will allow subject matter experts and other partners to test AI-based cancer care solutions using real-life data. The proposed infrastructure will also provide a platform for individual European citizens to donate their data for the purposes of cancer research.

“The Cancer Imaging Initiative will provide vital information for the next generation of cancer diagnostics and treatment and help us make screening more precise, timely and accessible. It is a key example of how we invest and make the best use of the potential of innovative digital solutions under Europe’s Beating Cancer Plan to change the realities for cancer patients and their families,” said Stella Kyriakides, European Commissioner for Health and Food Safety at the Cancer Imaging Initiative launch event in Brussels.

“Philips warmly welcomes this initiative as it offers access to health data in oncology and an excellent opportunity to engage with and collaborate with this community. This will help to develop AI-powered solutions derived from these data and validate them with clinical partners and customers such as La Fe Hospital in Valencia and Charité in Berlin. This initiative has immediate application in cancer AI-innovations, as these innovations rely on longitudinal patient data as well as a broad cohort to ensure robust AI solutions that be adopted into clinical practice,” said Tina Manoharan, Vice President of Data, AI and Digital Innovation at Philips.

Addressing the needs of expanded screening
One of the key aims of Europe’s Beating Cancer Plan is to ensure that 90% of the EU population who qualify for breast, cervical, or colorectal cancer screening are offered it by 2025, resulting in increased imaging volumes for screening and the precision diagnosis and personalized treatment of detected cases. AI is widely regarded as a powerful tool that could help radiologists cope with the workload. By combining AI with deep clinical knowledge, Philips is already creating AI-enabled solutions that integrate into and accelerate clinical workflows and provide clinicians with greater clarity at every moment of cancer care. Philips MRCAT (MR for Calculating Attenuation) Brain imaging software, for example, uses trained AI models to capture information needed to accurately and efficiently generate a patient’s radiotherapy plan in a single fast MR exam, without the need for a time and resource consuming CT scan and subsequent CT-MR image co-registration. In an ongoing partnership with Leiden University Medical Center (Leiden, The Netherlands) that recently benefited from EUR 2 million funding from the Dutch Research Council (NWO), Philips is developing innovative new AI solutions to further speed up and improve MR examinations, the aim being to reduce scan times from tens of minutes to less than five minutes and reconstructing detailed MR images despite patient or internal organ movement.

By automating and accelerating routine imaging tasks, Philips’ AI-based solutions aim to simplify workflows and logistics, leaving more time for clinicians to focus on their patients’ needs. At the same time, AI-enabled image reconstruction, quantitative analysis, and data integration tools allow oncologists to make better-informed decisions in diagnosis, therapy planning, treatment, and follow-up to provide patients with more precise and personalized cancer care.

Philips AI-enabled cancer care solutions
Philips intelligent Advanced Visualization and Pathway informatics solutions integrate data across radiology, pathology, genomics, and EHR systems to provide a comprehensive multi-faceted view of each individual patient’s unique cancer status, with plug-ins such as Multimodality Tumor Tracking, CT Spectral Tumor Tracking, and CT Virtual Colonoscopy to help aid decision-making. On top of that, the solution provides an additional layer of information access and management, including Dana-Farber Cancer Institute’s clinical pathways, genome informatics, clinical reporting, and clinical trial matching.

GE HealthCare, a leading global precision care innovator, announced that it has signed an agreement to acquire Caption Health, Inc., a privately owned artificial intelligence (AI) healthcare leader that creates clinical applications to aid in early disease detection, using AI to assist in conducting ultrasound scans. With Caption AI applications, ultrasound examinations can be easier and faster, enabling a broader set of healthcare professionals to conduct basic echocardiogram exams. This technology can help detect signs of diseases like heart failure in at-risk patients across doctors’ offices, the home, and alternate sites of care, potentially preventing hospitalizations and supporting improved clinical outcomes.

GE HealthCare Ultrasound President and CEO Roland Rott said, “Guiding ultrasound users during examinations with the help of AI is of growing importance, especially as we reach a broader set of healthcare professionals. Caption Health’s AI applications help enable reliable, consistent ultrasound examinations to deliver more precise diagnoses, improved treatment decision-making, and ultimately improved patient outcomes. This tuck-in acquisition will help expand affordable access to ultrasound imaging to novice users and is aligned with a broader shift to precision care globally.”

Caption Health CEO Steve Cashman said, “We are incredibly proud of the technology we have built and together with GE HealthCare, look forward to bringing this technology to more patients across the globe. Combining our AI applications with GE HealthCare’s ultrasound devices will help accelerate our mission to detect disease earlier, when an easily obtained diagnostic image can be a great equalizer to health quality and outcomes. This will ultimately help us reduce costs and enhance care.”

Heart ultrasound examinations are the primary tool used to help identify heart failure, the most common diagnosis in the U.S. for hospitalized patients over the age of 651. It contributes to millions of deaths globally every year, but early symptoms like fatigue or shortness of breath are commonly confused for normal signs of aging2. A study showed that 38% of new heart failure patients are diagnosed in acute care facilities, even though 46% of these patients had potential symptoms six months before diagnosis, when intervention would have had a greater impact in slowing disease progression3. Doctors call heart failure “the silent killer” because it is so easy to ignore symptoms until it is too late. It has remained a leading cause of death nationwide4, with cases on the rise following the COVID pandemic5.

Karley Yoder, Chief Digital Officer, Ultrasound at GE HealthCare, who will integrate Caption Health into the broader digital ecosystem of GE HealthCare, said, “We couldn’t be more excited to partner with the Caption Health team to increase access and accelerate growth of ultrasound. Caption Health will first be integrated in the Point of Care and Handheld business portfolio to advance ultrasound adoption, with expanded future use cases as well.”

As part of this acquisition, Caption Health will continue to provide management and administrative services to affiliated medical services providers (collectively referred to as “Caption Care”). By providing trained technicians across the country equipped with the Caption Health AI technology to perform cardiac ultrasounds in alternate sites of care and, in the future, in the comfort of patient’s homes, Caption Care service is intended to support early diagnosis and detection before diseases like heart failure become more difficult to treat.

Caption Health also has a strong development pipeline of AI software, including innovative technology for the use of ultrasound in pulmonary applications.

The consummation of the transaction is subject to customary closing conditions. Financial terms of the transaction are not being disclosed. GE HealthCare intends to fund this transaction with cash on hand.