Search Results for “medical device” – Page 74 – media

Making the Most of Real-World Data in Clinical Trials

Biomarkers, electronic health records (EHR), genomic data, imaging data, labs, social media, wearable sensors, and more provide enormous new sources of RWD that can aid in new discoveries for the quality, efficacy, and safety of new drug therapies. By DAVID BLACKMAN Clinical research is in the midst of a data explosion, and that’s a good thing. Technological advances are enabling access to secure and de-identified data sources for researchers, and the optimization of this data holds enormous potential for conducting clinical trials more efficiently, both from a cost and timeline perspective. The incorporation of real-world data (RWD), data gathered from actual patient experiences, in many ways represents an important step toward a fundamentally better understanding of states of disease and health. Biomarkers, electronic health records (EHR), genomic data, imaging data, labs, social media, wearable sensors, and more provide enormous new sources of RWD that can aid in new discoveries for ...
- Source: drugdu
- 177
- January 3, 2024
Boston Scientific initiates new Farapulse trial, expects FDA approval in 2024

BY SEAN WHOOLEY The Farapulse PFA system. [Image courtesy of Boston Scientific]Boston Scientific (NYSE: BSX)+ announced today that it initiated the AVANT GUARD clinical trial to evaluate its Farapulse pulsed-field ablation (PFA) system. The company also says it now anticipates FDA approval for Farapulse in the first quarter of 2024. AVANT GUARD looks at the safety and effectiveness of Farapulse as a first-line treatment for persistent AFib. Boston Scientific says this makes it the only trial studying the use of PFA as a frontline therapy in patients with this form of AFib. Farapulse is already a known commodity in the competitive PFA space. The nonthermal treatment uses electric fields to selectively ablate heart tissue. Boston Scientific bought Farapulse for nearly $300 million in 2021. The company shared its high hopes for the technology at its Investor Day event earlier this year, with analysts projecting FDA approval and rapid adoption in ...
- Source: drugdu
- 188
- December 30, 2023
CMEF 2024

CMEF(full name: China International Medical Equipment Expo) was founded in 1979, held twice a year in the spring and autumn, after more than 40 years of innovation and development, has become the world's leading covering the whole industry chain, scientific and technological innovation, new product launch, business docking, brand communication, academic exchange, trend insight, education and training in one of the medical health technology platform. With the theme of "Innovation and Technology leading the Future", this year's CMEF covers tens of thousands of whole-department and whole-industry chain product technologies and solutions for medical imaging, in vitro diagnosis, medical electronics, medical optics, hospital construction, operating room, disinfection sensor control, medical consumables, orthopedic medical robots, etc.
- Source: drugdu
- 207
- December 27, 2023
Orthofix has positive spine stimulation tech data

BY SEAN WHOOLEY rthofix Medical (Nasadaq: OFIX)+ today announced new data investigating pulsed electromagnetic field (PEMF) stimulation with lumbar spinal fusion. Lewisville, Texas-based Orthofix evaluated PEMF stimulation as an adjunct to lumbar spinal fusion procedures in patients at risk for pseudoarthrosis. Patients treated with the SpinalStim bone growth device demonstrated a high rate of successful fusion. They also showed significant improvements in pain, function and quality of life, despite having risk factors for pseudoarthrosis. SpinalStim, an FDA-approved bone growth stimulation therapy, offers an adjunct treatment for lumbar spinal fusion. It also functions as a nonsurgical treatment for spinal pseudoarthrosis. The device utilizes PEMF technology that provides 360 degrees of treatment coverage around the fusion site. Orthofix says its system has an overall success rate of 92% in treating spinal fusion surgery patients. Researchers published their data evaluating the SpinalStim system in the International Journal of Spine Surgery. Lead author Dr. ...
- Source: drugdu
- 182
- December 27, 2023
NHS trials home testing for chronic kidney disease

Tens of thousands of patients at risk of kidney disease will be able to get tested from the comfort of their own homes as part of a £30 million tech and AI innovation fund this winter. The Healthy.io early detection device will initially be sent to 30,000 patients who are considered most at risk for kidney disease. Analysis suggests the device could help detect 1,300 cases of undiagnosed chronic kidney disease (CKD) over the coming months, as well as stopping some patients from developing end-stage renal disease – improving outcomes for individuals and reducing pressure on the NHS by preventing unplanned hospital admissions. Patients place a small device in a urine sample before scanning the device into an app which gives immediate results on whether a patient may have a kidney condition. The test results are immediately uploaded to the patient’s electronic medical record for clinical review. The National CKD ...
- Source: drugdu
- 102
- December 27, 2023
FDA Roundup

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA issued a guidance for industry titled, “Rare Diseases: Considerations for the Development of Drugs and Biological Products” This guidance clarifies the FDA’s thinking on important considerations in rare disease drug development to ultimately assist rare disease drug and biologic product developers in conducting successful drug development programs. For more information and to submit a comment about this guidance, please visit Rare Diseases: Considerations for the Development of Drugs and Biological Products; Guidance for Industry; Request for Comments. On Thursday, the FDA warned consumers not to use counterfeit Ozempic (semaglutide) found in U.S. drug supply chain. The FDA continues to investigate counterfeit Ozempic (semaglutide) injection 1 milligram (mg) in the legitimate U.S. drug supply chain and has seized thousands of units of the product. The agency advises wholesalers, retail pharmacies, ...
- Source: drugdu
- 111
- December 26, 2023
Smartwatches prove effective in detecting heart arrhythmias in children

A recent study published in the journal Communications Medicine discusses how smartwatches can facilitate the diagnosis of arrhythmias in children. Background Smartwatches and other wearable devices are becoming increasingly popular and allow users to constantly monitor their health, leading to their value for medical diagnosis becoming well-recognized. While the utility of these devices for adults has been widely researched, including for cardiac health monitoring and reducing the time needed to detect symptomatic rhythms, little is known about how they can be used to monitor child health indicators. Palpitations and abnormalities in cardiac rhythms are a leading cause of referrals in pediatric cardiology. However, existing non-invasive methods like patch rhythm monitors are not always effective in diagnosing arrhythmias, as symptoms often present infrequently, and children cannot wear monitors for as long as adults. Invasive methods such as implantable loop monitors (ILR) allow long-term monitoring. However, this approach may not be ideal ...
- Source: drugdu
- 111
- December 20, 2023
Imperative Care begins first-in-human study of neurovascular stent

BY SEAN WHOOLEY Imperative Care announced today that it initiated a first-in-human clinical study for its novel neurovascular stent system. Campbell, California-based Imperative Care designed the system to only require single antiplatelet therapy for patients undergoing stent-assisted treatment of wide-neck intracranial aneurysms. Dr. Nobuyuki Sakai successfully treated the first three patients enrolled in the study. Sakai serves as director of neurosurgery at the Kobe City Medical Center General Hospital in Kobe City, Hyogo, Japan. All three patients underwent planned procedures for stent-assisted coiling of unruptured aneurysms. Imperative Care reported all three patient discharges from the hospital within 48 hours on an aspirin-only antiplatelet regimen. The company reported no device- or procedure-related complications, including clot formation. “The ability for neurovascular implants to avoid dual antiplatelet drug therapy, which carries the risk of serious bleeding complications, will be an important step forward,” said Sakai said in a news release. “I am encouraged ...
- Source: drugdu
- 125
- December 18, 2023
Nanopore Sequencing Cuts Tumor Analysis Times and Costs, Finds Study

Copy number variations (CNVs), which activate oncogenes and inactivate tumor suppressor genes, play a crucial role in the development and progression of cancers. As such, CNV analysis is a vital component of tumor grading and diagnosis. Traditionally, this analysis relies on nucleotide hybridization and next-generation sequencing, methods confined to high-complexity centralized laboratories and requiring several days to complete. A more rapid, cost-effective, and straightforward approach to CNV analysis could significantly enhance clinical decision-making, refine surgical planning, and facilitate the identification of potential molecular therapies within the timeframe of surgical procedures. Researchers have now identified nanopore sequencing as a method to refine CNV analysis. A study conducted by researchers at Dartmouth-Hitchcock Medical Center (DHMC, Lebanon, NH, USA) has found nanopore sequencing to be a more efficient means for CNV analysis. They used Oxford Nanopore’s MinION device, which offers real-time interpretation of long-read nucleotide sequences. To adapt this technology for CNV detection, ...
- Source: drugdu
- 102
- December 13, 2023
Bright Uro Snags $23M To Make Urology Diagnostics Easier for Providers & Patients

Bright Uro raised $23 million in Series A funds to help achieve FDA clearance for its urodynamics system and launch the product in the U.S. Should it be cleared, the system will become the first product on the market able perform urodynamic monitoring wirelessly and without a catheter, the company’s CEO said. By KATIE ADAMS Bright Uro, a Irvine, California-based startup founded in 2021, is on a mission to make urodynamic testing more accurate for clinicians, more comfortable for patients, and more efficient for clinics. On Thursday, the company announced it has raised $23 million to help it get closer to achieving those goals — the Series A funding round was led by Laborie Medical Technologies, a provider of urology diagnostic and therapeutic products. The round reflects the total amount of equity investment Bright Uro has raised since its founding, said CEO Derek Herrera. The startup also received a $2 ...
- Source: drugdu
- 150
- December 5, 2023

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