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In April, FDA Commissioner Dr. Robert Califf laid out areas of challenge and opportunity when it comes to improving healthoutcomes, restoring public trust in science, and making the most of our ongoing investments in data analytics and clinical research. Wang, Chief Medical Officer of COTA, Inc.
What You Should Know: – Withings , a global leader in connected health, has announced that its Sleep Rx sleep apnea device has received clearance from the U.S. Food and Drug Administration (FDA). Improved Patient Outcomes: Early diagnosis and treatment of sleep apnea can lead to better healthoutcomes.
– TytoCare , a virtual care company enabling accessible, high-quality primary care from home, today announced that it received FDA clearance for its Tyto Insights for Wheeze Detection, paving the way for its rollout in the US. The Tyto Insights for Wheeze Detection already bears the CE Mark for usage by clinicians in Europe.
What You Should Know: – Teladoc Health , the global leader in virtual care announced a partnership with Gifthealth , a digital pharmacy platform and partner of Eli Lilly’s LillyDirect program , to improve access to tirzepatide (brand name Mounjaro) for weight management. Group Health at Teladoc Health.
While many consumer-grade wearables may not fall under FDA regulations, the data they collect necessitates adherence to stringent data privacy laws. While patient-generated health data from wearables such as these hold huge potential, challenges remain in integrating this data into existing healthcare systems.
First, let’s examine the new regulatory framework the FDA established. Health plans offering the OTC benefit can also leverage the opportunity to educate members about the significant role hearing aids can play in improving their overall health. – What new opportunities will arise? Introducing OTC hearing aids.
FDA Awards Breakthrough Device Designation to Fire1s Norm System FIRE1 , a leading connected medical device solutions company, today announced the successful completion of a $120 million financing round to accelerate the companys mission to transform the lives of millions of people living with heart failure.
senators have pressed the FDA to take steps to eliminate pulse oximetry’s racial bias, which has caused delays in treatment and worse healthoutcomes, and more recently has raised concern about the reliability of hospital AI tools that draw on reams of data from the devices. . The FDA’s response was modest.
The lawsuits, arising from the desire to hold platforms accountable for exploiting children’s susceptibility to rewarding stimuli during development, present a novel theory of liability based solely on an algorithm’s ability to cause addiction rather than adverse mental healthoutcomes.
The virtual caregiver is designed to engage with and help monitor the health of aging, chronically ill and child patients via touchscreen devices placed throughout a residence. Individual patients can purchase "Flow Health" for $599. "Addison is a.
What You Should Know: – SoundHealth , a medical technology company focused on harnessing AI for better healthoutcomes, has launched SONU , the world’s first FDA-cleared AI-powered wearable for treating moderate to severe nasal congestion.
UpScriptHealth also works with other medical device companies to increase access – for example, it powers telehealth consultations for Spark Biomedical's Sparrow Ascent, the only FDA-cleared, drug-free, non-addictive, non-invasive, wearable treatment technology for the relief of opioid withdrawal symptoms.
Food and Drug Administration (FDA) released a draft guidance that, if finalized, will update the agency’s 2018 guidance on its Breakthrough Devices Program (the “Program”). To address health disparities, FDA proposes adding new section III.B.3.d On October 21st, the U.S.
What You Should Know: Sonio, the artificial intelligence company revolutionizing fetal ultrasounds, announced today that their proprietary approach to ultrasound exams on pregnant people has now been recognized in the United States as a product that meets health performance and safety standards.
By eliminating the need for wearables, its FDA-listed technology provides lab-quality gait and motion analysis in seconds, enabling healthcare providers to assess, treat, and monitor patients remotely. “This partnership ensures senior living communities can leverage cutting-edge technology to support better healthoutcomes.”
AutoZone’s HealthOutcomes for Employees. – Clinically Significant Weight Loss: Across all groups, patients saw at least 8% weight loss on average (5% is the benchmark for FDA-approved weight-loss drugs and what is considered clinically significant).
Sean Brady, CEO and cofounder of Ventric Health, is doing his part to turn this problem around. He is head of the team behind a newly FDA-cleared cardiac device designed to help manage the challenges around heart failure. Please describe your newly FDA-cleared cardiac device for heart failure and discuss how it works.
These data insights can accelerate medical discoveries in the pharmaceutical and research fields, enable the acceleration of precision medicine and personalized treatments, help clinics improve the efficiency and effectiveness of medical care, and ultimately, drive better healthoutcomes.
The participant’s digital twin forecasts their healthoutcomes under placebo, regardless of their actual assignment. TwinRCTs reduce the time it takes to bring new drugs and therapies to market, ultimately paving the way for improved healthoutcomes for all. Founder and CEO at Unlearn. or follow us on X and LinkedIn.
Xandar Kardian’s XK300 Autonomous Health Monitoring Solution is the world’s first and only commercially available, contact-free, continuous VSM (vital sign monitoring) system that is FDA 510(k) cleared as a class II medical device.
PH affects up to 1% of the global population and is a marker of poor healthoutcomes.¹ Pulmonary hypertension is a severe condition that occurs when the pressure in the vessels that carry blood from the heart to the lungs is higher than normal, causing undo stress on the heart. A previous $2.7M
Another study in Frontiers highlighted the potential of mobile health solutions in low- and middle-income countries to enhance patient treatment and rehabilitation by providing low-cost, accessible healthcare through smartphones, tablets, wearable sensors, mobile applications, and telemedicine platforms.
By using them, providers can enhance patient engagement, allowing for personalized and proactive care management that drives better healthoutcomes and better care experiences. Connected care at-home technologies enable behavior change and empower individuals and clinicians to make informed decisions about healthcare treatment.
Abbott and others in their core business space of pharma, specialty medicines, and medical devices are now part of the expanding digital therapeutics world that marries software to medical goods – whether a pill or device – to bolster healthoutcomes, adherence, and quality.
OneStep: Revolutionizing Remote Physical Therapy with Smartphone-Based Gait and Motion Analysis OneStep leverages smartphone motion sensors to provide continuous, clinically-validated gait and motion analysis in real-life conditions without the need for wearables.
It combines TytoCare’s FDA-cleared handheld remote examination device, which performs heart, lung, throat, ear, and body temperature exams, with Tyto Insights™ clinical decision support software and Tyto Engagement Labs™.
a precision medicine company, announced a venture investment from PACE Healthcare Capital , an early-stage investment firm committed to improving healthoutcomes. Prenosis is currently seeking to obtain FDA clearance for the tool by the end of 2022. What You Should Know: – Prenosis, Inc.,
Although it is well established that diversity improves outcomes and drives excellence, implementing diversity lags behind in many industries, including life sciences and healthcare. experience significant health disparities , including higher rates of chronic disease and premature death compared to the white population.
Since DTx plays such a substantive role in the therapeutic process, these apps must meet the same standards of clinical evidence required by the FDA and other regulatory agencies for approval of conventional medical treatments. FDA website, March 27, 2018. – The richness and size of the real-world datasets.
While hospitals have the money and resources to use a variety of Federal Drug Administration-approved sensors and instruments to gain a holistic view of the necessary health data and deliver the best possible care for patients, the consumer care marketplace is not yet that advanced. Compliance.
Their innovative approach uses digital twins, AI-generated models that predict individual patient healthoutcomes under different treatment scenarios. AI-Powered Clinical Trials with Digital Twins Founded in 2017, Unlearn has consistently pushed the boundaries of AI in clinical research. founder and CEO of Unlearn.
Fund grant opportunities to state, local, or tribal health departments, community-based organizations, Indian organizations, or other public or private entities for projects that would improve healthoutcomes and reduce health disparities. Senators Murray and Burr expect the legislation to progress this year.
The beauty here is that once an app has detected a condition, users are then able to take guided action to improve healthoutcomes and lower their risks. Several factors play a part in this, from the need for FDA clearance to general user error. Unfortunately, most health apps are currently not regulated.
What You Should Know: – Eko Health , a provider of AI-powered heart and lung disease detection today announced FDA clearance for its Low EF detection AI. – Built in collaboration with Mayo Clinic, the AI allows U.S.
That a pharmaceutical company executive is speaking on the main stage at CES speaks to digital health’s mainstreaming beyond elite athletes and smartwatches that track activity. Other forces on the demand side of health/care converge with this supply side to make the market for tech-enabled, consumer-facing health care.
The platform has embedded video conferencing, or works alongside the video conferencing platform a health system has in place. It also equips providers with Eko’s FDA-cleared AI to assist in remote screening for AFib, heart murmurs, tachycardia and bradycardia. Vivify Health. iRhythm Technologies.
The ultimate goal is to develop innovative clinical trials that yield medical breakthroughs to improve preventive care and healthoutcomes for patients. One trial is evaluating an FDA-approved remote robotic ultrasound system to effectively capture expert quality cardiac ultrasound images remotely. Current Clinical Trials.
Zerigo Health’sFDA-cleared, natural light therapy solution safely and effectively shifts dermatological care from the clinic to the controlled convenience of home, keeping physicians and their patients with chronic skin conditions connected with personalized data and insights.
Food and Drug Administration (FDA). As healthcare systems implement AI tools thoughtfully and securely, they create opportunities for stronger connections between clinicians and patients, leading to restored trust in medical care and improved healthoutcomes. AI implementation must be systematic and thoughtful.
Leveraging TytoCare’s FDA-cleared, AI-powered lung and wheeze detection, these exams replicate the quality of in-person clinic visits, providing vital health services without requiring physical presence at medical facilities.
“That’s why we’ve developed a first-of-its-kind metabolic health program specifically designed for adolescents. Our goal is to encourage and set behavioral and lifestyle changes that will lead to healthier habits and better long-term outcomes.” In fact, a 2022 clinical trial found a 16.1 To learn more, visit knownwell.co.
Although marketing a drug prior to FDA approval is illegal, marketing a disease is not; in fact, disease mongering for a specific drug starts years before the treatment is expected to be approved. The post How pharmaceutical marketing affects decisions about patient care appeared first on Kaiser Permanente Institute for Health Policy.
This shift, driven by the FDA’s Diversity Action Plans, will accelerate trial enrollment, improve representation, and ultimately enhance patient safety by ensuring more diverse data in research. These networks ensure employees can receive top-tier care regardless of location, enhancing satisfaction and improving healthoutcomes.
The ability to accurately and reliably leverage the massive amount of data that is routinely collected throughout the healthcare arena and use it to amplify the clinical findings of the randomized clinical trial creates enormous opportunities for improved prescribing and improved healthoutcomes for patients.
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