Maria Perez
Maria is an experienced writer, providing content for Healthcare Industry News since 2021. Working as a senior writer, Maria focuses on news reporting, making the complex healthcare topic comprehensible for readers. Maria’s expertise and dedication to delivering accurate stories make him a trusted source on our site.
by Maria Perez | Apr 24, 2024 | Digital Health
Philips is facing regulatory scrutiny after an inspection by the U.S. Food and Drug Administration (FDA) at its Suzhou, China facility revealed multiple compliance issues concerning its computed tomography (CT) and ultrasonography systems. During the October 2023 inspection, the FDA identified that the devices were “adulterated” within the context of the Federal Food, Drug, and Cosmetic Act, indicating non-conformance with good manufacturing practice requirements. Specifically, Philips failed to validate an injection molding process necessary for manufacturing a data cable used in its Incisive CT machines. This lack of validation led to the cable being redesigned following 64 complaints regarding cable connection issues, which were linked to potential delays in diagnosis due to ECG gating signal errors.
Further compounding the regulatory challenges for Philips, the FDA found that the company had not reported three specific field corrections associated with the Incisive CT machines to the agency as required. These corrections were important as they were intended to reduce risks to patient health, including a cable connection failure that could delay diagnoses and software defects that could result in reversed or upside-down images or image artifacts, potentially leading to misdiagnoses. The FDA’s warning letter to Philips noted that these omissions in reporting were serious and outlined the need for a more in-depth review by Philips, extending beyond the initial two-year period they had examined. This situation reflects a broader issue of oversight and reporting within Philips’ operations, as evidenced by similar issues with other devices, including the company’s sleep and respiratory devices, which are also under scrutiny.
Adding to the oversight failures, the FDA’s letter disclosed that Philips did not correctly manage the control over its product, services, suppliers, contractors, and consultants. This was evident in the insufficient validation of the injection molding process used by Philips’ supplier for the custom-manufactured data cables. Although Philips responded to the initial FDA findings by halting the distribution of the problematic cables and requalifying the supplier to meet validation requirements, the agency found these measures inadequate. The FDA criticized Philips for its limited range in reviewing and ensuring the quality and compliance of its parts and processes, suggesting that this could be indicative of more systemic problems within the company’s quality management systems.
In response to the FDA’s findings and the subsequent warning letter, Philips has stated its commitment to addressing the issues raised and to enhancing its processes to prevent future occurrences. The company has undertaken to extend the review timeframe for field safety notices and to reassess all parts supplied to its Suzhou facility. Philips also aims to improve its Advanced Product Quality Plan process and has updated its protocols for managing product corrections and removals. Despite these efforts, the ongoing challenges highlight the importance of strict quality control and regulatory compliance in the manufacturing of medical devices, particularly those that are necessary for diagnostic accuracy. Philips’ experience serves as a cautionary tale for the medical device industry, emphasizing the need for continuous oversight and adherence to regulatory standards to ensure patient safety and trust in medical technologies.
by Maria Perez | Apr 24, 2024 | Artificial Intelligence
Exo has recently advanced the capabilities of its Iris handheld ultrasound system by integrating new FDA-cleared artificial intelligence (AI) tools aimed at enhancing the diagnosis and management of cardiac and lung conditions. These tools, now available on the high-performance, pocket-sized device, promise to transform patient care by providing immediate diagnostic insights. Particularly beneficial for health systems and practitioners in rural or under-resourced areas, these AI enhancements simplify the process of image acquisition and interpretation, making sophisticated medical imaging more accessible and cost-effective. The introduction of AI into Exo Iris extends to several specific applications, such as the ability to quantify bladder volume, and now includes tools that assist in measuring cardiac ejection fraction and detecting lung structures and artifacts. These tools have been designed to support healthcare professionals in making informed decisions quickly, which is necessary for conditions like heart failure where timely intervention can alter outcomes.
Exo’s AI tools will have a big impact on healthcare delivery, particularly in point-of-care settings. With over 6.7 million Americans currently suffering from heart failure, there is a need for accessible and reliable diagnostic methods that can be deployed directly at the patient’s side. Exo’s AI applications, validated across diverse patient populations and health conditions, enable healthcare providers to perform important diagnostics without the need for high-end lab equipment. For example, the cardiac AI tool can quickly measure left ventricular ejection fraction, a key indicator of heart health, while the lung AI tool helps in identifying signs of pulmonary edema. These capabilities streamline the diagnostic process and reduce the dependency on specialized imaging technicians, decreasing the overall healthcare delivery costs and enabling more frequent and widespread use of ultrasound technology.
Innovation in ultrasound technology, as demonstrated by Exo, also includes the integration of Pulsed-Wave Doppler capabilities in the Iris system, enhancing the device’s utility in cardiac, abdominal, and vascular applications. This addition broadens the range of Exo’s diagnostic tools, allowing for more detailed examinations of blood flow and velocity, which are necessary for an in-depth assessment of various health conditions. The continuous expansion of FDA-approved AI functionalities within the Iris system shows Exo’s commitment to advancing medical imaging technology. By doubling the number of its FDA clearances by 2025, Exo plans to further enhance the capabilities of the Iris system, supporting a broader range of diagnostic needs and potentially transforming it into a must-have tool in modern healthcare practices.
Exo is allowing access to advanced medical imaging through initiatives like making its products available via a new e-commerce channel. This approach supports the acquisition of the latest medical technology by healthcare providers and allows the widespread adoption of AI-powered tools in routine clinical practice. By providing these tools in a user-friendly and cost-effective format, Exo aims to allow those with limited experience in point-of-care ultrasound (POCUS) to perform complex diagnostics. The availability of these tools online is complemented by Exo’s award-winning POCUS workflow software, Exo Works®, creating a medical imaging system that fits into the pocket of healthcare providers. Through these innovations, Exo addresses the immediate needs of healthcare professionals and contributes to the broader goal of improving patient outcomes and efficiency within healthcare systems.
by Maria Perez | Apr 23, 2024 | Digital Health, Telehealth News
Summer Health has secured $11.65 million in Series A funding to enhance its technology platform, aimed at revolutionizing pediatric care through a text-based service. The platform is designed to respond to medical inquiries within 15 minutes, serving as a virtual extension of a family’s primary pediatrician. This innovative approach primarily targets the accessibility issues faced by parents during non-working hours, where typically, the only alternative is a costly and time-consuming trip to urgent care. By providing immediate text-based access to pediatric advice, Summer Health reduces the necessity for these urgent care visits, easing the burden on parents and the healthcare system.
The idea for creating Summer Health came from Ellen DaSilva, the company’s founder and CEO, who, as a parent of three, experienced firsthand the frustrations of accessing timely pediatric advice. Her background as an early executive at Hims & Hers provided her with insights into the digital health market, which she used to create a service that utilizes the simplicity of smartphones. The service supports text communication and allows for the transmission of photos and videos, supporting the consultation process. This nature of communication ensures that parents can receive healthcare advice without disrupting their daily activities, whether they are at work or attending their child’s soccer game.
Since its creation in July 2022, Summer Health has completed over 30,000 visits, a testament to its rapidly growing acceptance and the need for such services. The recent funding round was led by Lux Capital and 7WireVentures, with participation from existing investors such as Sequoia Capital and Metrodora Ventures, as well as new contributors like Pivotal Ventures, a fund by Melinda French Gates. The investment team includes parents who are active users of the service, showing their personal and professional belief in the company’s impact. As the digital health landscape continues to evolve post-pandemic, investors like Alyssa Jaffee of 7WireVentures see growth potential for platforms that address genuine and expanding healthcare needs.
Summer Health plans to use the Series A funding to expand its technology platform further and broaden the range of its services. Ellen DaSilva has outlined ambitious plans to include features such as visual diagnostics and home testing for children, which could transform how pediatric care is delivered by moving more services into the home setting. The company also aims to enhance its backend technology using generative AI to streamline administrative tasks for providers. This initiative includes a partnership with OpenAI to develop features like automated medical visit notes, which helps in maintaining efficiency and HIPAA compliance. As Summer Health aims to make pediatric care accessible for all 75 million children in the U.S., including those on Medicaid, its innovative use of technology and commitment to expanding access could have a strong influence on the future of pediatric healthcare delivery.
by Maria Perez | Apr 18, 2024 | Artificial Intelligence
Amid the escalating burnout crisis affecting healthcare professionals across the United States, a shift towards embracing AI-driven solutions is evident. Surveys, such as one recently conducted by Athenahealth and Harris Poll, highlighted that nearly all U.S. physicians report feelings of burnout, with many contemplating drastic career changes. This overwhelming burnout is largely attributed to the excessive administrative tasks that take time away from patient care. In response, a growing number of health systems are integrating AI technologies like AI scribes and generative AI tools. These innovations aim to alleviate the administrative load, enabling doctors to dedicate more time to direct patient interactions. The adoption of such technologies is not just a strategy for efficiency but is also increasingly viewed as necessary for enhancing patient care quality and physician job satisfaction.
Technology firms are offering sophisticated solutions that redefine clinical documentation processes. Companies such as Microsoft’s Nuance, Abridge, and Suki are allowing the use of voice technology that seamlessly translates doctor-patient dialogues into structured clinical notes, directly integrated into electronic health records (EHRs). These AI tools include features like advanced dictation, coding, and even real-time data retrieval for answering clinical questions. For example, Suki claims its technology can reduce the time physicians spend on notes by 72%, decreasing the rate of claim denials and amended encounters. These technological advances not only streamline workflow but also open up new areas for revenue generation and operational efficiencies within health systems.
The practical application of these AI tools in clinical settings is illustrated by the adoption strategies of large health systems such as the Rush University System for Health. Their partnership with Suki to pilot an AI assistant across their network demonstrates a proactive approach to combating clinician burnout. Rush’s choice reflects a broader trend where health systems are are aiming for deep integration with existing digital health records systems like Epic. This integration is necessary for ensuring the widespread adoption of AI technologies by making them an important part of the healthcare delivery process, minimizing disruption to existing clinical workflows. The enthusiasm for these AI solutions is noticeable among healthcare providers who anticipate benefits in terms of reduced workload and improved patient interaction quality.
Despite the promising advancements and optimistic adoption of AI tools in healthcare, challenges remain. The integration of AI into healthcare settings raises concerns about the potential loss of the human touch in patient care, a factor that healthcare providers are keen to retain. While AI applications promise to reduce the burden of administrative tasks, there is a need for transparency regarding the data used to train these systems. Physicians emphasize the importance of understanding the origin and creation of the data to trust AI’s role in clinical decision-making. The healthcare sector’s journey towards fully integrating AI tools involves not only technological adoption but also addressing ethical considerations, ensuring data privacy, and maintaining the delicate balance between efficiency and personal care. As the sector progresses, the continuous refinement of these technologies will be important in realizing the full potential of AI to mitigate burnout and enhance healthcare delivery.
by Maria Perez | Apr 17, 2024 | Digital Health
Eli Lilly’s innovative drug, Zepbound, also known by its scientific name tirzepatide, has demonstrated efficacy in treating obstructive sleep apnea (OSA) in overweight or obese individuals, according to recent findings from two late-stage clinical trials. The trials investigated the effects of Zepbound on individuals with moderate-to-severe OSA, both those using continuous positive airway pressure (CPAP) devices and those not using them. Zepbound achieved a remarkable reduction in the apnea-hypopnea index (AHI), which measures the severity of sleep apnea by recording the number of partial and complete airway blockages per hour of sleep. Specifically, in the study group not using CPAP devices, Zepbound reduced the average hourly number of sleep apnea events by 55%, a reduction of 27 events per hour, compared to a minimal reduction in the placebo group. In the CPAP user group, the drug reduced sleep apnea events by 63%, or 30 events per hour, again outperforming the placebo. These results highlight Zepbound’s potential as a direct treatment for OSA but also suggest its role in enhancing the quality of life for individuals struggling with this sleep disorder.
The implications of Zepbound’s efficacy extend beyond the primary symptom relief, as the studies also recorded weight loss in participants, which is particularly relevant given the strong linkage between obesity and OSA. Participants in the non-CPAP trial experienced an 18% reduction in body weight, while those in the CPAP trial saw a 20% reduction, compared to only 1-2% weight loss in the placebo groups. This weight loss contributes directly to the reduction in OSA severity, as excess weight is a major exacerbator of the disorder. The dual benefits of Zepbound could position it to manage OSA associated with obesity, providing a layered approach by simultaneously addressing the root cause and the symptoms of the disorder.
Lilly plans to submit this data to the U.S. Food and Drug Administration (FDA) and other global regulatory bodies, aiming for an expanded indication of Zepbound for the treatment of OSA. The drug has already received Fast Track designation from the FDA for its potential in treating sleep apnea and obesity, signaling a recognition of the urgent need for effective therapies in these areas. The full dataset from these trials is expected to be disclosed at the upcoming American Diabetes Association annual meeting and subsequently published in a peer-reviewed medical journal. These steps are part of Lilly’s broader strategy to enhance the clinical understanding and therapeutic potential of GLP-1 agonists, a class of drugs traditionally used in diabetes management that is now finding a new role in treating complications associated with obesity and metabolic dysfunction.
The broader impact of these findings is important, considering the current treatment landscape for OSA, which primarily revolves around mechanical interventions like CPAP machines that many patients find inefficient and uncomfortable. The introduction of a pharmacological treatment that can reduce the severity of OSA symptoms and facilitate weight loss could revolutionize the standard of care, offering patients a potentially more appealing treatment option. This could especially benefit the number of patients who are either intolerant of or non-compliant with CPAP therapy. With obesity rates continuing to rise globally, the demand for effective weight management solutions that can also address associated issues like OSA is higher than ever. Zepbound’s development and potential market approval could mark a big step forward in the management of these interconnected health issues, setting a new standard for treatment of these health concerns.
