Search Results for “medical devices” – Page 48 – media

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
- 84
- 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
- 133
- 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
- 83
- February 27, 2024
Building a Digital Stockpiling Strategy One Shelf At A Time

The Covid-19 pandemic was a teachable moment for the medical device industry. It laid bare to vulnerabilities within the U.S. healthcare system, including how quickly our supply chain can be disrupted, the impacts on medical inventory and stockpiles of personal protection equipment (PPE), and staff shortages. In a survey by Ernst & Young, 57% of companies admitted facing serious disruptions during these times. In an industry where medical supply inventory is mission-critical, and disruption is not an option, it is important to revisit your health plan and pivot in strategies so when these unforeseen events occur, you are ready for anything that comes your way. From physical to digital Right now, considerable preparation is shoring up the physical equipment supply chain for frontline workers and patients. Truth be told, the impacts of having a digital health production plan are significant. While digital stockpiling is still an undervalued strategy among medical ...
- Source: drugdu
- 104
- January 30, 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
- 146
- January 17, 2024
J&J’s Megadyne restricts use of electrodes over burn risk, triggering Class I FDA notice

Dive Brief The Food and Drug Administration has categorized an urgent medical device correction from Johnson & Johnson’s Megadyne as a Class I event. Megadyne contacted customers last month to restrict the use of four electrode products in children under the age of 12 years. The products are staying on the market with a narrower label. The J&J unit took the action after receiving reports of burn injuries that could be particularly harmful to children. Megadyne has received reports of 99 injuries and no deaths, according to the FDA’s Monday recall notice. Dive Insight The electrode pads help direct currents from certain instruments used during surgery through the patient’s body to prevent the risk of energy concentrating in one area and burning the patient, according to the FDA. Megadyne sent an urgent field safety notice about the burn risk in June, leading to a Class I notice from the FDA ...
- Source: drugdu
- 176
- January 11, 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
- 166
- January 5, 2024
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
- 107
- 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
- 109
- December 20, 2023
Medtronic to chase Boston Scientific, Abbott in left atrial appendage closure market

Dive Brief Medtronic said Monday it is launching a device in the U.S. designed to close the left atrial appendage (LAA) of the heart in patients undergoing cardiac surgery. The treatment is intended for patients who have atrial fibrillation (AFib), an arrhythmia that can lead to stroke. The introduction of the implantable LAA clip, called Penditure, marks Medtronic’s entry into the fast-growing market for left atrial appendage closure devices, led by Boston Scientific’s Watchman franchise. Medtronic said it acquired the LAA exclusion system in August from Miami-based medical device incubator Syntheon, in a move to expand its cardiac surgery portfolio. Terms of the transaction were not disclosed. Dive Insight Medtronic’s device is the newest challenger to Boston Scientific’s Watchman in a growing market that includes Abbott’s Amplatzer Amulet treatment, which gained approval from the Food and Drug Administration in 2021, and AtriCure, whose AtriClip device was the first LAA exclusion ...
- Source: drugdu
- 170
- November 30, 2023

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