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The Perils of Over-Regulating AI in Healthcare and Life Sciences | By Adnan Masood, PhD. Chief AI Architect

Over-Regulating AI in Healthcare and Life Sciences
Adnan Masood, PhD. Chief AI Architect

As an AI researcher and practitioner deeply embedded in the healthcare and life sciences sectors, I see the passage of California’s SB 1047 as a complex issue with significant implications. This controversial bill, now heading to Governor Newsom’s desk, represents a fundamental misunderstanding of AI as a general-purpose technology. It attempts to regulate the technology itself rather than focusing on specific, problematic applications.

It goes without saying that AI is not a monolith – but a versatile tool capable of numerous applications—from driving diagnostic tools in hospitals to powering chatbots in customer service. However, SB 1047 does not seem to distinguish between these vastly different use cases. It broadly imposes liability on AI developers, assuming they can predict and control every potential use of their technology downstream. This is not only unrealistic but stifles innovation by placing undue legal burdens on developers who are often far removed from how their tools are eventually used.

Consider this analogy: regulating AI in this manner is like holding a scalpel manufacturer liable for every possible use of their tool, whether it’s for life-saving surgery or a criminal act. It’s absurd to regulate the scalpel itself rather than its specific, potentially harmful applications. This approach would be like requiring all scalpel manufacturers to install a “safety lock” to prevent any misuse, regardless of the context in which it’s used. Such broad-brush regulation will chill innovation, deter investment, and create a maze of compliance that many developers, particularly smaller startups and open-source contributors, simply cannot navigate.

Our UST AI survey reflects this concern. A whopping 90% of respondents acknowledge the need for some level of regulation. Still, there is a fine line between regulation that ensures safety and one that throttles innovation. The risk here is over-regulation—laws that are too broad, too vague, and too onerous, resulting in a stifling effect on the open-source community and academic research. Open models have been crucial for advancing AI safety and encouraging competition. By raising compliance costs, SB 1047 threatens to shut down this vital avenue for innovation.

The healthcare and life sciences industries in particular stand to lose significantly if SB 1047 becomes law. AI is a transformative force in these fields. It drives innovations such as predictive analytics for patient care, AI-enhanced imaging techniques, and personalized medicine. Each of these applications involves complex, data-driven models that evolve through continuous learning and iteration. The fear is that such a regulation will force developers to operate defensively, slowing down or halting the open sharing of AI models and algorithms crucial for medical advancements.

The “kill switch” requirement in SB 1047 stems from hypothetical risks rather than real-world challenges, especially in healthcare, where AI models must be robust, accurate, and continuously evolving—not subject to abrupt shutdowns driven by unfounded fears. This could drive AI innovation into silos, reducing collaboration and oversight from academic and open-source communities. Now Governor Newsom faces a choice: address valid concerns about unchecked AI development or avoid over-regulating a transformative technology. We need targeted regulations focusing on specific, tangible risks, not broad punitive measures that stifle innovation.

I believe that the regulation should promote an environment where AI can advance healthcare, not hinder its potential to improve patient care and medical science. Thoughtful, precise regulation that recognizes AI’s diverse applications is crucial for its future in healthcare and beyond.

Editor’s Note:  Adnan Masood, PhD., is the Chief AI Architect at the global digital solutions company UST. Engineer, researcher, and a forward thinker who is passionate about developing highly innovative breakthrough technologies. Adnan strives to bridge the gap between cutting-edge academic research and industry. He was previously the regional director at Microsoft and is a visiting scholar at Stanford University’s School of Engineering.

 

Acquisition of Critical Care from Edwards Lifescience Completed | Reports BD

BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced it has completed the acquisition of Edwards Lifesciences’ Critical Care product group, which will be renamed as BD Advanced Patient Monitoring.

BD Advanced Patient Monitoring is a global leader in advanced monitoring solutions that expands BD’s portfolio of smart connected care solutions with its growing set of leading monitoring technologies, advanced AI-enabled clinical decision tools and robust innovation pipeline. BD Advanced Patient Monitoring’s technologies are often used simultaneously with the BD Alaris™ Infusion System in the operating room or intensive care units. The combination of BD’s new advanced monitoring and existing infusion platforms enables future innovation opportunities for closed-loop hemodynamic monitoring and IV fluid and medication administration by integrating combined company data sets and interoperability capabilities.

Tom Polen, chairman, chief executive officer and president of BD:

“The health care industry is being redefined by AI, robotics, and autonomous solutions, and our team continues to accelerate the application of these new technologies to improve the quality and cost of patient care around the world. Today, BD is proud to welcome BD Advanced Patient Monitoring, whose leading technologies, AI-enabled solutions and strong innovation pipeline expand our portfolio of smart, connected care solutions, create significant value for customers, and put BD at the forefront of enabling the future of health care.”

BD Advanced Patient Monitoring’s portfolio includes the gold-standard Swan Ganz pulmonary artery catheter, minimally invasive sensors, noninvasive cuffs, tissue oximetry sensors and monitors. Its smart technologies are driven by advanced data analytics with machine learning and AI-based predictive and prescriptive algorithms to help clinicians better understand current and future patient conditions and provide clinical decision support tools.

BD Advanced Patient Monitoring will operate as a separate business unit within BD’s Medical segment to align with its smart connected care approach, and it will maintain its presence in Irvine, Calif. Katie Szyman, who has served as corporate vice president of the business under Edwards since 2015, has been named worldwide president of BD Advanced Patient Monitoring, reporting to Mike Garrison, executive vice president and president of the BD Medical segment.

The completion of the acquisition is expected to have an immaterial impact to the previously disclosed BD fiscal year 2024 guidance provided in the August 1 third quarter earnings news release. For additional information about the transaction, please reference the Investor Presentation and Transaction Announcement Press Release issued on June 3, 2024, both available on the Investor page on BD.com.

Vision-based ChatGPT Shows Deficits Interpreting Radiologic Images

Researchers evaluating the performance of ChatGPT-4 Vision found that the model performed well on text-based radiology exam questions but struggled to answer image-related questions accurately. The study’s results were published today in Radiology, a journal of the Radiological Society of North America (RSNA).

Chat GPT-4 Vision is the first version of the large language model that can interpret both text and images.

“ChatGPT-4 has shown promise for assisting radiologists in tasks such as simplifying patient-facing radiology reports and identifying the appropriate protocol for imaging exams,” said Chad Klochko, M.D., musculoskeletal radiologist and artificial intelligence (AI) researcher at Henry Ford Health in Detroit, Michigan. “With image processing capabilities, GPT-4 Vision allows for new potential applications in radiology.”

For the study, Dr. Klochko’s research team used retired questions from the American College of Radiology’s Diagnostic Radiology In-Training Examinations, a series of tests used to benchmark the progress of radiology residents. After excluding duplicates, the researchers used 377 questions across 13 domains, including 195 questions that were text-only and 182 that contained an image.

GPT-4 Vision answered 246 of the 377 questions correctly, achieving an overall score of 65.3%. The model correctly answered 81.5% (159) of the 195 text-only queries and 47.8% (87) of the 182 questions with images.

“The 81.5% accuracy for text-only questions mirrors the performance of the model’s predecessor,” he said. “This consistency on text-based questions may suggest that the model has a degree of textual understanding in radiology.”

Genitourinary radiology was the only subspecialty for which GPT-4 Vision performed better on questions with images (67%, or 10 of 15) than text-only questions (57%, or 4 of 7). The model performed better on text-only questions in all other subspecialties.

The model performed best on image-based questions in the chest and genitourinary subspecialties, correctly answering 69% and 67% of the image-containing questions, respectively. The model performed lowest on image-containing questions in the nuclear medicine domain, correctly answering only 2 of 10 questions.

The study also evaluated the impact of various prompts on the performance of GPT-4 Vision.

  • Original: You are taking a radiology board exam. Images of the questions will be uploaded. Choose the correct answer for each question.
  • Basic: Choose the single best answer in the following retired radiology board exam question.
  • Short instruction: This is a retired radiology board exam question to gauge your medical knowledge. Choose the single best answer letter and do not provide any reasoning for your answer.
  • Long instruction: You are a board-certified diagnostic radiologist taking an examination. Evaluate each question carefully and if the question additionally contains an image, please evaluate the image carefully in order to answer the question. Your response must include a single best answer choice. Failure to provide an answer choice will count as incorrect.
  • Chain of thought: You are taking a retired board exam for research purposes. Given the provided image, think step by step for the provided question.

Although the model correctly answered 183 of 265 questions with a basic prompt, it declined to answer 120 questions, most of which contained an image.

Although the model correctly answered 183 of 265 questions with a basic prompt, it declined to answer 120 questions, most of which contained an image.

“The phenomenon of declining to answer questions was something we hadn’t seen in our initial exploration of the model,” Dr. Klochko said.

The short instruction prompt yielded the lowest accuracy (62.6%).

On text-based questions, chain-of-thought prompting outperformed long instruction by 6.1%, basic by 6.8%, and original prompting style by 8.9%. There was no evidence to suggest performance differences between any two prompts on image-based questions.

“Our study showed evidence of hallucinatory responses when interpreting image findings,” Dr. Klochko said. “We noted an alarming tendency for the model to provide correct diagnoses based on incorrect image interpretations, which could have significant clinical implications.”

Dr. Klochko said his study’s findings underscore the need for more specialized and rigorous evaluation methods to assess large language model performance in radiology tasks.

“Given the current challenges in accurately interpreting key radiologic images and the tendency for hallucinatory responses, the applicability of GPT-4 Vision in information-critical fields such as radiology is limited in its current state,” he said.

“Performance of GPT-4 with Vision on Text- and Image-based ACR Diagnostic Radiology In-Training Examination Questions.” Collaborating with Dr. Klochko were Nolan Hayden, M.D., Spencer Gilbert, B.S., Laila M. Poisson, Ph.D., and Brent Griffith, M.D.

Radiology is edited by Linda Moy, M.D., New York University, New York, N.Y., and owned and published by the Radiological Society of North America, Inc. (https://pubs.rsna.org/journal/radiology)

RSNA is an association of radiologists, radiation oncologists, medical physicists and related scientists promoting excellence in patient care and health care delivery through education, research and technologic innovation. The Society is based in Oak Brook, Illinois. (RSNA.org)

For patient-friendly information on medical imaging, visit RadiologyInfo.org.

AliveDx Receives IVDR-CE Mark for Multiplexed Assay to Accurately Detect Celiac Disease on the MosaiQ® System

AliveDx mission is to empower diagnostic insights, transform patient care, and innovate for life. We are excited and proud to announce AliveDx has received IVDR-CE mark certification for its multiplexed MosaiQ AiPlex™ CD microarray immunoassay, designed to improve the accuracy and speed of diagnosing celiac disease. Receiving the IVDR-CE mark means the assay meets the rigorous IVDR standards set by the European Union, ensuring it is safe, effective, and ready for widespread clinical use in geographies accepting the CE mark certification. AliveDx is expanding its impact across CE mark accepting geographies, helping to improve the lives of those affected by celiac disease.

A global challenge

Celiac disease is a chronic autoimmune disorder with a global prevalence of 1 in 100[1], primarily affecting the small intestine, often accompanied by a variety of multiorgan clinical symptoms. The immune system’s abnormal response in celiac disease is triggered by the consumption of gluten in genetically susceptible individuals, leading to the production of autoantibodies and small bowel damage.

Diagnosis of celiac disease typically involves serological testing for specific autoantibodies, with other clinical, laboratory, imaging, genetic, and histopathological findings. For instance, clinical guidelines recommend testing for IgA autoantibodies against tissue Transglutaminase (anti-tTG IgA) and Deamidated Gliadin Peptides (anti-DGP IgA).

Given that some individuals with celiac disease may have selective IgA deficiency, it is advised to measure total IgA levels alongside autoantibodies. In cases of IgA deficiency, testing for relevant IgG autoantibodies (e.g., anti-tTG IgG, anti-DPG IgG) is recommended. It is important for users to consult current guidelines for further details.

Simplified workflow, fast results, actionable insights

The newly IVDR-CE marked MosaiQ AiPlex CD microarray immunoassay offers healthcare providers with a novel, unique solution to help shorten the diagnostic delay and reduce the unnecessary burden of celiac disease testing. By including the most clinically relevant autoantibodies, i.e. tTG IgA, DGP IgA, tTG IgG and DGP IgG as well as the detection of total IgA antibodies, it is designed to provide more complete diagnostic insights with a single sample and blood draw and to help laboratories automate and streamline the celiac disease diagnostic pathway. Once diagnosed with celiac disease, patients can benefit quickly from Gluten-Free Diet (GFD) to reduce gastrointestinal symptoms as well as to prevent long term, potentially severe health implications.

The MosaiQ AiPlex CD approval enhances our current autoimmune turnkey solution of MosaiQ, MosaiQ AiPlex CTD, and LumiQ portfolio. Additionally, AliveDx expects to significantly grow the menu of its MosaiQ autoimmune and allergy portfolio in 2025 and beyond.

“We are thrilled to obtain the CE mark for our MosaiQ AiPlex CD microarray,” said Manuel O. Mendez, CEO of AliveDx. “The MosaiQ fast portfolio expansion marks our fourth microarray CE mark approval in the last 12 months reflecting our dedication to rapidly advance diagnostic technologies and our commitment to support the millions of individuals affected by autoimmune diseases. Early and accurate diagnosis is crucial for managing this condition. Our innovative MosaiQ microarray solutions represent a significant advancement to partner with laboratorians and clinicians to reduce healthcare costs and improve patient outcomes and quality of life.”

About MosaiQ platform

A fully automated high-throughput platform that streamlines multiplex testing for Autoimmune, Allergy, and beyond. This intuitive platform delivers fast and accurate results using advanced microarray panels to rapidly detect and identify disease markers in up to 425 results per hour. With an expanding portfolio of tests, it continues to maximize workflow efficiencies, simplify pathways, and help shorten time to diagnosis.

*1 Rubio-Tapia A et al. Am J Gastroenterol. 2023;118(1):59-76.

SKG1108 Receives FDA Orphan Drug Designation for Retinitis Pigmentosa | Reports Skyline Therapeutics

Skyline Therapeutics, an innovation-driven gene therapy company committed to developing unique and novel solutions for rare and severe diseases, announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for SKG1108, a novel one-time intravitreally delivered gene therapy for the treatment of Retinitis Pigmentosa (RP). This designation reflects the recognition by the FDA of the potential of SKG1108 for treating RP. The ODD grants special status to SKG1108 and qualifies it for various benefits, which will greatly accelerate the development of the drug and enhance patient access to the leading-edge therapeutic solution.

SKG1108 is a recombinant adeno-associated virus (rAAV) vector with innovative design, utilizing the novel intravitreal capsid AAV.0106 to deliver single-stranded DNA encoding light-activatable proteins directly to the retina. The protein, regulated by specific genetic elements, aims to improve or restore visual function by generating new photo-sensing cells, thereby compensating for the loss of rod and cone photoreceptors in patients with late-stage RP, agnostic on the specific gene or genetic mutation responsible for the condition.

RP is a type of inherited retinal diseases (IRDs) linked to mutations in over 100 different genes or loci, all leading to progressive vision loss. While the age of onset is varied, most RP patients are classified as legally blind by their 40s. The disease typically begins with the degeneration of rod cells, followed by the gradual loss of cone cells, and ultimately leads to the near-complete loss of all photoreceptor cells, leaving the retina non-functional and resulting in blindness. Currently, there are no effective treatments worldwide that can halt or reverse photoreceptor degeneration. Existing therapies targeting specific mutant genes apply only to a small subset of RP patients. SKG1108, an innovative gene therapy that employs a novel approach to improve or restore patients’ visual perception and acuity independent of the underlying genetic defects, holds great potential to benefit a broader range of RP patients.

About Orphan Drug Designation (ODD)
Orphan Drug Designation (ODD) is a status granted by the FDA to drugs or biological products that show promise in treating, preventing, or diagnosing rare diseases. The goal of granting ODD is to encourage innovation and research in the development of treatments for rare diseases and to make these treatments available more quickly. ODD qualifies drug sponsors for incentives including tax credits for qualified clinical trials, exemption from the prescription drug user fees, and potential seven years of market exclusivity after approval.

Recor Medical Supports European Society of Cardiology’s Hypertension Guidelines

Recor Medical
Recor Medical Paradise System for uRDN

Recor Medical, Inc. (“Recor”) and its parent company, Otsuka Medical Devices Co., Ltd. (“Otsuka Medical Devices”) have endorsed the updated recommendations for the management of hypertension by the European Society of Cardiology (ESC), which were presented at the ESC Congress on Friday, August 30, 2024.

The new guidelines, “2024 ESC Guidelines for the management of elevated blood pressure and hypertension,” have been published online and recommend the consideration of renal denervation (RDN) as a safe and effective treatment option for patients who have uncontrolled resistant hypertension or those that have uncontrolled hypertension with a higher risk of cardiovascular disease, who express a preference to undergo RDN.

Hypertension, or high blood pressure, affects more than one billion people worldwide. It is known as the “silent killer” because many people do not know they have it and, over time, it can lead to serious health issues. About three-fourths of the patients who are treated for hypertension remain uncontrolled despite making healthy lifestyle changes and taking multiple medications. Recor’s Paradise™ Ultrasound Renal Denervation (uRDN) system is a first-of-its-kind ultrasound-based renal denervation technology designed to lower blood pressure by denervating overactive sympathetic nerves surrounding the renal arteries in patients whose hypertension is not controlled by medications alone.

“This presented guidance from the ESC Congress 2024 is a big step forward for patients who require a safe and effective option to control hypertension when lifestyle changes and medications are unsuccessful. The recommendation is based on the demonstrated efficacy and safety of renal denervation in randomized sham-controlled trials, and I am very pleased that RDN is now recommended in the ESC Guidelines as a treatment option for refractory and non-adherent patients,” commented Prof. Dr. Michael Böhm, Cardiologist and Clinic Director of Internal Medicine III, Saarland University Hospital in Homburg. “As presented at the congress the ESC guidelines recommend that renal denervation be performed in medium-to-high volume centers after multidisciplinary assessment and with a shared risk benefit discussion with the patient. It is now up to us to implement these guidelines in everyday clinical practice and provide patients with the services they need.”

Recor Medical has completed three global, independently powered, sham-controlled randomized clinical trials of the Paradise uRDN system in more than 500 patients with uncontrolled hypertension. The RADIANCE-HTN SOLO, RADIANCE-HTN TRIO and RADIANCE II clinical studies met their prespecified primary efficacy endpoints of blood pressure reduction, with positive safety outcomes. The Paradise system received CE mark in 2012, and Recor has been actively working with the European cardiology community to bring ultrasound RDN therapy to patients in the region. The growing support of societies like the ESC provides further momentum for the ongoing adoption of Recor’s hypertension therapy.

“We are delighted that the ESC guidelines recommend the consideration of renal denervation as an effective option to treat uncontrolled hypertension,” said Recor President and CEO, Lara Barghout. “The urgent global need to address the burden of uncontrolled hypertension remains, and we’re committed to revolutionizing the way hypertension is treated by bringing the benefits of Paradise ultrasound RDN to patients who need it.”

ProBiotix Health Strengthens Global Presence With DanCare Chinese Distribution Deal

ProBiotix Health Plc (‘ProBiotix’), a life sciences company developing probiotics to support cardiometabolic health, has strengthened its global footprint with a new partnership agreement with supplement specialist DanCare for the distribution of its InstaMelt product in China.

This strategic move marks a significant step for ProBiotix Health in penetrating the Chinese health and nutrition market with cardiometabolic supplement solutions. The InstaMelt formulation, ProBiotix’s newly developed food supplement, offers innovative features for health brands and retailers, and will be fully rebranded as a finished turn-key solution by DanCare.

InstaMelt is a direct dose stick solution that melts instantly on the tongue and contains ProBiotix’s proprietary IP protected probiotic strain LPLDL®, shown through comprehensive human studies to improve multiple cardiometabolic health biomarkers including decreasing harmful LDL cholesterol and increasing HDL cholesterol levels.

Steen Andersen, CEO of ProBiotix, commented: “This partnership with DanCare, a well-recognised high-quality innovative brand in China, positions us to address the growing consumer focus on cardiometabolic health in the region. With reports showing that cardiovascular disease is on the rise and an estimated 155 million Chinese adults having elevated cholesterol levels, our collaboration with DanCare enables us to effectively engage with this market, and support health and nutrition brands across China.

“InstaMelt is a fantastic solution for brand owners in the Chinese market, demonstrating how ProBiotix is putting a key focus not only on scientific evidence, but also on innovative, convenient and consumer-led delivery methods. Our approach meets the evolving needs of consumers while maintaining the highest standards of efficacy.”

DanCare, founded in 2003, has evolved from supplying branded products to the European supplement industry to becoming a global supplement and functional ingredient organisation with a strong presence in China. The company offers a broad range of clinically documented, high-quality supplements marketed globally under the DanCare brand.

The CEO and spokesperson of DanCare China commented: “We are looking forward to this collaboration with ProBiotix Health as our two companies share the same vision of improving quality of life by bringing efficacious, high quality innovate supplements to market. The significant clinical documentation backing the strain LPLDL®, in combination with the innovative new stick dosage format and DanCare’s strong market position, will be an excellent addition to our product line in the Chinese market. This sets high growth expectations for the product. We are excited to see where this dynamic partnership leads.”

Set to launch under the DanCare brand in Q4 2024, InstaMelt is available in fresh fruity flavours, designed to be taken once daily after a main meal. Aligning with the diversity of today’s global health consumer market, it is vegan, allergen-free and GMO-free.

This partnership agreement represents a key milestone in ProBiotix’s drive to expand its reach and bring its innovative cardiometabolic health solutions to the global market to support longer and healthier lives.

CMR Surgical Bolsters Leadership Team

CMR Surgical (CMR or ‘the Company’), the global surgical robotics business, today announces the appointment of Markus Bauman as Chief Legal & Business Affairs Officer, joining the Company’s executive leadership team.

Markus Bauman brings to CMR over two decades of significant in-house legal experience, as well as experience at global world-renowned law firms. He has worked with innovative European companies and has significant expertise in public and private company financings and mergers and acquisitions. He is currently a member of the Atomico Expert Network, providing counsel and support to Atomico’s portfolio of technology firms and is a Board Member of the University of Illinois Foundation. Previously, he served as Chief Legal Officer and General Counsel at Matillion, a software company specialising in data integration and transformation for cloud data warehouses. Prior to this, he was a Partner and Head of European Strategic Relations at Goodwin and built his expertise at other leading international law firms and investment banks, including JP Morgan and Goldman Sachs. Markus holds a JD/MBA in Law and Business from the University of Illinois Urbana-Champaign.

CMR Surgiucal also announce the appointment of Michelle Paknad who has joined CMR as Senior Vice President, Global Business Development. Michelle will be responsible for helping to further accelerate the Company’s commercial efforts to bring Versius to more hospitals around the world. Michelle brings more than 20 years of leadership experience in the medical devices sector, with particular expertise in sales and marketing, within the area of soft-tissue surgical robotics having held senior sales and marketing roles at Intuitive Surgical. She was most recently Vice President of Global Robotics and Digital Health at Smith & Nephew where she ran the robotics franchise. Prior to this, she held senior positions at Intuitive Surgical, including Director of Sales and Marketing for Asia Pacific. Michelle holds an MBA from Golden Gate University and a BA in Business Economics and Biochemistry from the University of California.

Supratim Bose, Chief Executive Officer at CMR Surgical, commented: “On behalf of the leadership team, I am delighted to welcome Markus and Michelle to CMR. Markus will be a key addition to the executive leadership team with his wealth of expertise in corporate law, strategic relations and financial operations. Michelle, with her extensive soft-tissue surgical robotics experience, will be instrumental in accelerating our commercial efforts and we look forward to utilising her skillset.”

Markus Bauman, Chief Legal & Business Affairs Officer at CMR Surgical said: “Given my experience of working with ambitious disruptive European businesses, I am looking forward to bringing my legal expertise to a company that is challenging the status quo in order to help bring more robotic-assisted surgery to patients around the world. Versius is a truly innovative technology, and I will work with the leadership team to ensure hospitals can realise the potential of this technology.”

Michelle Paknad, Senior Vice President, Global Business Development at CMR Surgical added: “I am excited to join a Company that is looking to disrupt the surgical robotics market. Soft-tissue surgical robotics is such a fast growing and changing market, and I look forward to bringing my extensive experience in this industry to partner with surgeons and hospitals so that more patients can get the benefits of robotic-assisted surgery with Versius.”

Iridium Network Becomes 1st Center In the World to Use RayCare and TrueBeam to Treat a Patient

RaySearch Laboratories AB (publ) announced that Iridium Network in Belgium has treated its first patient using RaySearch’s oncology information system RayCare®* together with a Varian TrueBeam®** linear accelerator. The treatment was successfully carried out on September 2, 2024.

Since its establishment in 2006, Iridium Network has grown to become the largest radiotherapy network in Belgium, providing highly specialized radiation oncology for three hospital networks in the larger region of Antwerp, as well as being a leading expertise center with an international reputation. In total, the network has ten TrueBeam linear accelerators, installed at four sites, treating more than 6,000 patients with radiation therapy each year.

Iridium Network and RaySearch have a close and long-standing collaboration. The network became a clinical partner to RaySearch in late 2015 when it acquired RayStation and has also strongly contributed to the development of RayCare. In 2018 the network became the first hospital in the world to clinically use RayCare, only two months after the release of the system.

Dr. Piet Dirix, Radiation Oncologist, Iridium Network, says: “My team and I are extremely happy to have been part of the journey of developing RayCare to what it is today, a next generation oncology information system designed to incorporate all disciplines of cancer care. We aspire to create one oncology workflow, allowing a seamless experience for both patients and health care professionals.”

As previously announced, the interoperability certificate between RayCare 2024A and TrueBeam was issued in May 2024, and applies to all linear accelerators in the TrueBeam family: TrueBeam, TrueBeam STx, Edge and VitalBeam. And once again, only a couple of months after the announcement, Iridium Network reaches an important milestone for RayCare, becoming the first hospital to take RayCare in clinical use together with TrueBeam.

Prof. Dirk Verellen, Director Medical Physics, Iridium Network, says: “With RayCare we achieve consistency and automation, two factors that play a crucial role in maintaining patient safety, efficiency and quality of care. RayCare strongly contributes to our ability to offer cutting-edge radiation oncology solutions to patients throughout our network.”

Johan Löf, founder and CEO, RaySearch: “RayCare is the result of a strong partnership between industry and clinical experts in developing an integrated oncology information system and I am proud of our long-standing collaboration with Iridium Network. Today, when RayCare was connected with TrueBeam, an important milestone was clinically manifested for our shared commitment to advancing cancer care with the patient in focus.”

* Subject to regulatory clearance in some markets.

** The marks Varian and TrueBeam are trademarks of Varian Medical Systems Inc.

Cold Weather Exposure Linked to Increased Risk of Heart Attacks

Hospital admissions for heart attacks increase after exposure to lower air temperature and cold spells, according to a study published today in JACC, the flagship journal of the American College of Cardiology, and presented at the European Society of Cardiology (ESC) Congress 2024. The findings underscore the need to understand further the physiological effects of global warming’s contribution to colder weather in specific regions and cold-related cardiac risks.

“This nationwide study reveals that short-term exposures to lower air temperature and cold spells are associated with an increased risk of myocardial infarction (MI) hospitalization after two -six days, suggesting that individuals may be particularly vulnerable to acute cardiac events during periods of cold stress,” said Wenli Ni, PhD, lead author of the study and a postdoctoral research fellow at Harvard University.

JACC Editor-in-Chief Harlan M. Krumholz, MD, SM, FACC, said the study reveals a crucial link between cold weather exposure and heart attack risk, highlighting a delayed effect that peaks days after the cold spell.

“These findings also underscore the urgent need for targeted interventions to protect vulnerable populations during and, particularly, after cold stress,” Krumholz said.

Heart attacks, or MI, occur when blood flow to a part of the heart is blocked, usually by a blood clot. This blockage prevents oxygen from reaching the heart muscle, causing damage or death to that part of the muscle.

Previous studies have revealed low temperatures had a greater cardiovascular burden than high temperatures worldwide. Due to a lack of data from colder regions with extreme weather conditions, researchers based this study in Sweden, a region known for its cold climate where cold spells are common.

Tracking 120,380 individuals from the SWEDEHEART registry, researchers examined how short-term exposure to lower air temperatures and cold spells influenced the risk of heart attack hospital admissions during Sweden’s cold season (October to March) from 2005 to 2019.

For this study, researchers defined cold spells as a period of at least two consecutive days where the average daily temperature was colder than the 10th percentile of temperatures recorded across the study duration.

Results revealed that lower air temperature exposure was associated with an increased risk of total MI, NSTEMI and STEMI after two to six days. Cold spell exposure after two to six days was associated with the same increased risks.

Researchers also found exposure from day zero to one decreased the risk of heart attack hospitalizations. They said that this temporary protective effect could be due to behavior modifications during cold weather, like staying indoors to reduce exposure or delaying healthcare due to service disruptions; however, those behaviors are not sustainable and could account for the delay in hospitalizations to two to six days later.

“This temporal pattern may indicate a delayed onset of cold-related impacts on MI risk, aligning with prior research underscoring delayed cardiovascular effects of cold exposure,” Ni said. “Understanding this cold-to-MI risk lag sequence may be important for designing and implementing targeted preventive interventions.”

Effects on first-time and recurrent MI were also observed independently but the difference in these effects between first-time and recurrent MI was not statistically significant.

In an accompanying editorial comment, Kai Chen, PhD, an associate professor of Epidemiology at the Yale School of Public Health and Khurram Nasir, MD, a professor of Cardiology at the Houston Methodist, said the study’s findings call for reevaluating how health care professionals approach the intersection of environmental factors and cardiovascular health.

“Our approaches must be reevaluated in the context of increasingly unpredictable climate patterns,” Chen and Nasir said. “Addressing both ends of the temperature spectrum will ensure our healthcare systems are well equipped to manage and mitigate these challenges, ultimately fostering a more sustainable and resilient cardiovascular future.”