Search Results for “medical device” – Page 73 – media

New smartphone-based method for high-quality gait analysis

Researchers at Kennedy Krieger Institute and Johns Hopkins Medicine have developed a new, accessible approach to analyze a patient’s walking ability and stances more effectively. Following numerous tests, they determined that a simple video recorded on a personal pocket device, such as a smartphone or tablet, can be used to measure gait at a clinical, high-quality level. Experts say current state-of-the-art approaches to gait analysis are often expensive and inaccessible due to time constraints and extensive efforts required for assessments. However, there is a significant need for this analysis in patients experiencing conditions such as traumatic brain injury, physical injury, or disorders. Through freely available software they created, walking abilities can now be assessed more conveniently, enhancing the comprehensiveness of rehabilitation. Dr. Ryan Roemmich, a research scientist at the Kennedy Krieger Institute, assistant professor of physical medicine and rehabilitation at the Johns Hopkins University School of Medicine, and co-principal investigator ...
- Source: drugdu
- 149
- March 30, 2024
FDA Clears First Over-the-Counter Continuous Glucose Monitor

Today, the U.S. Food and Drug Administration cleared for marketing the first over-the-counter (OTC) continuous glucose monitor (CGM). The Dexcom Stelo Glucose Biosensor System is an integrated CGM (iCGM) intended for anyone 18 years and older who does not use insulin, such as individuals with diabetes treating their condition with oral medications, or those without diabetes who want to better understand how diet and exercise may impact blood sugar levels. Importantly, this system is not for individuals with problematic hypoglycemia (low blood sugar) as the system is not designed to alert the user to this potentially dangerous condition. “CGMs can be a powerful tool to help monitor blood glucose. Today’s clearance expands access to these devices by allowing individuals to purchase a CGM without the involvement of a health care provider,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “Giving more individuals valuable ...
- Source: drugdu
- 85
- March 7, 2024
Comprehensive protein analysis reveals potential targets for treating dialysis-related amyloidosis

Dialysis patients often develop dialysis-related amyloidosis and exhibit bone and joint disorders that impair their activity of daily living. Blood purification devices consisting of hexadecyl-immobilized cellulose beads aimed at removing the precursor protein, β2- microglobulin (β2-m), are used in the treatment of dialysis-related amyloidosis. Dr. Yamamoto et al. investigated that comprehensive analysis of proteins adsorbed onto blood purification devices revealed the identification of 200 types of proteins, including β2-m. Among these, several molecules, such as lysozyme, were shown to be involved in amyloid fibril formation. I. Background of the study Patients with advanced chronic kidney disease (CKD) require kidney replacement therapy, such as hemodialysis, to manage their condition. Hemodialysis patients often experience various symptoms, leading to a compromised quality of life and reduced activity levels. Itching is a common symptom frequently observed in hemodialysis patients. Although its exact causes remain unclear, a survey conducted in Japan in 2000 found that ...
- Source: drugdu
- 135
- March 4, 2024
February 23, 2024

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA announced its final decision to withdraw approval of Pepaxto (melphalan flufenamide), which was approved for use in combination with dexamethasone to treat certain patients with multiple myeloma. The agency determined the following grounds for withdrawal were met: (1) the confirmatory study conducted as a condition of accelerated approval did not confirm Pepaxto’s clinical benefit, and (2) the available evidence demonstrates that Pepaxto is not shown to be safe or effective under its conditions of use. The final decision was issued by the FDA’s Center for Biologics Evaluation and Research Director Peter Marks, M.D., Ph.D., as the Commissioner’s designee. The decision is effective immediately. The FDA plans to publish a Federal Register notice announcing the availability of today’s decision and remove Pepaxto from the Orange Book. It is the FDA’s ...
- Source: drugdu
- 86
- February 27, 2024
CRISPR Test Diagnoses Mpox Faster Than Lab-Based PCR Method

Mpox, formerly known as monkeypox, is a rare viral disease transmitted through physical contact and typically presents mild symptoms like fever, rash, and swollen lymph nodes, though severe cases can require medical intervention. Due to its contagious nature, prompt testing is crucial for isolation and treatment purposes. Current mpox testing requires laboratory equipment and may take hours to yield results. Now, new research suggests a way for faster mpox testing that could be done in any clinic. Researchers at Pennsylvania State University (University Park, PA, USA) have utilized CRISPR, the groundbreaking gene-editing technology, to develop a faster mpox test. For their study, the team designed a genetic sequence with an attached reporter specifically targeting the mpox virus. The test employs programmable CRISPR RNA that binds to the target and a protein called Cas12a, which together cleaves the reporter to produce fragments of varying sizes. Using nanopore sensing technology, these reporter ...
- Source: drugdu
- 129
- February 16, 2024
Smart Palm-size Optofluidic Hematology Analyzer Enables POCT of Patients’ Blood Cells

Variations in blood cell concentration can be indicative of several health conditions, including infections, inflammatory diseases, malignant blood disorders, and AIDS (Acquired Immune Deficiency Syndrome). Detecting these variations is crucial for diagnosing, treating, and managing these diseases. Traditional methods for measuring blood cell concentration, like using a hemocytometer, typically require an optical microscope. Alternatively, flow cytometers offer a more efficient method for sorting and counting blood cells in fluids, but they are often large and complex, weighing between 9-30 kg, thus limiting their use to laboratory and hospital settings. This restricts the availability of point-of-care testing (POCT) and can delay treatment for patients. Now, a proposed portable smart blood cell analyzer could help overcome the limitations of conventional methods for blood cell concentration detection. Developed by the Harbin Institute of Technology (HIT, Heilongjiang, China), this innovative analyzer integrates a miniature fluorescence microscope, typically used in neuroscience and behavioral research, with ...
- Source: drugdu
- 115
- January 19, 2024
Smart Palm-size Optofluidic Hematology Analyzer Enables POCT of Patients’ Blood Cells

Variations in blood cell concentration can be indicative of several health conditions, including infections, inflammatory diseases, malignant blood disorders, and AIDS (Acquired Immune Deficiency Syndrome). Detecting these variations is crucial for diagnosing, treating, and managing these diseases. Traditional methods for measuring blood cell concentration, like using a hemocytometer, typically require an optical microscope. Alternatively, flow cytometers offer a more efficient method for sorting and counting blood cells in fluids, but they are often large and complex, weighing between 9-30 kg, thus limiting their use to laboratory and hospital settings. This restricts the availability of point-of-care testing (POCT) and can delay treatment for patients. Now, a proposed portable smart blood cell analyzer could help overcome the limitations of conventional methods for blood cell concentration detection. Developed by the Harbin Institute of Technology (HIT, Heilongjiang, China), this innovative analyzer integrates a miniature fluorescence microscope, typically used in neuroscience and behavioral research, with ...
- Source: drugdu
- 121
- January 19, 2024
FDA Clears AnX Robotica’s NaviCam SB for Expanded Indications

Mike Hollan The device can produce AI-assisted readings. FDA announced that it has cleared the NaviCam Small Bowel Video Capsule Endoscopy for expanded indications. In a press release, the device’s producer AnX Robotica, revealed the agency’s decision. According to the company, the NaviCam SB is one of the most advanced pieces of technology available for small bowel video capsule endoscopy. The device uses AI to assist medical professionals as they perform tests. FDA also cleared the company’s NaviCam Tether to be used as an accessory with the NaviCam SB. These devices are designed to work together and can improve the visualization process of the esophagus. In a press release, AnX Robotica’s vice president of marketing and product management Stu Wildhorn said, “With FDA clearance, NaviCam Small Bowel Capsule Endoscopy represents a groundbreaking leap forward, now extending its revolutionary diagnostic capabilities to patients as young as 2 years old. Furthermore, clinicians ...
- Source: drugdu
- 148
- January 17, 2024
Lilly Pens Open Letter Raising Concerns Regarding Use of Mounjaro for Cosmetic Weight Loss

Don Tracy, Associate Editor Company cites potential safety risks for patients who ignore the intended indication of Mounjaro and Zepbound. In a letter to the public, Eli Lilly and Company warned against the use of its medicines for cosmetic weight loss. Citing the fact that neither Mounjaro or Zepbound are indicated for cosmetic purposes, the pharma company stressed that both are intended to treat serious diseases, with Mounjaro focusing on type 2 diabetes and Zepbound for obesity in specific BMI ranges of a BMI of 30 kg/m2 or greater or those who are overweight with a BMI ≥ 27 kg/m2 or greater. Additionally, caution is advised for patients with severe gastrointestinal conditions and the medications should only be prescribed by licensed healthcare professionals. “Patients should consult with their healthcare providers to determine whether Mounjaro or Zepbound is right for them,” the company stated in a press release. “Mounjaro and Zepbound ...
- Source: drugdu
- 177
- January 8, 2024
Wearing hearing aids could extend people’s lifespan

Hearing loss affects approximately 40 million American adults, yet only one in 10 people who need hearing aids use them, research shows. Those who don’t use hearing aids but should may want to make wearing them one of their New Year’s resolutions, according to a new study from Keck Medicine of USC published today in The Lancet Healthy Longevity.  Janet Choi, MD, MPH, an otolaryngologist with Keck Medicine and lead researcher of the study said, “We found that adults with hearing loss who regularly used hearing aids had a 24% lower risk of mortality than those who never wore them. These results are exciting because they suggest that hearing aids may play a protective role in people’s health and prevent early death.” Previous research has shown that untreated hearing loss can result in a reduced life span (as well as other poor outcomes such as social isolation, depression and dementia). ...
- Source: drugdu
- 168
- January 5, 2024

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