Search Results for “medical devices” – Page 50 – media

Boston Scientific expects ‘dramatic shift’ to pulsed field ablation to fuel fast growth through 2026

Dive Brief Boston Scientific has set bullish growth targets for 2024 to 2026, according to analysts. The company is forecasting that a “dramatic shift” to pulsed field ablation will increase its organic revenues by 8% to 10% over the period. Analysts went into Boston Scientific’s investor day expecting 7% to 9% growth. Some analysts left the event speculating that Boston Scientific can exceed its 10% target after being convinced that PFA and left atrial appendage closure can power the company toward its goal. Boston Scientific forecast that the global atrial fibrillation ablation market will grow from $5 billion today to $8 billion in 2026 and $11 billion by 2028. PFA’s share of the market is predicted to rise from less than 5% today to 40% to 60% in 2026 and 60% to 80% in 2028. Dive Insight Boston Scientific forecast an 8% to 10% organic sales compound annual growth rate ...
- Source: drugdu
- 240
- September 25, 2023
GE HealthCare partners with Mayo Clinic to accelerate work on imaging and AI

Dive Brief GE HealthCare has teamed with Mayo Clinic to advance medical imaging, artificial intelligence and theranostics, a type of cancer treatment that involves imaging and targeted therapeutics. The organizations will collaborate on the application of AI to magnetic resonance imaging, the automation of diagnostic and interventional ultrasound and other activities that could improve patient care. GE HealthCare has formed a series of partnerships since separating from its parent company, striking deals with companies including Boston Scientific, Johnson & Johnson and Medtronic. Dive Insight GE HealthCare and other parts of its former parent company, GE, have a long history of working with Rochester, Minnesota-based Mayo, teaming up with the hospital to test remote monitoring devices, found a gene therapy software startup and develop a medical electronic record system. The latest deal brings together scientists, technology developers and clinicians working at GE HealthCare and Mayo to collaborate on four core areas ...
- Source: drugdu
- 124
- September 18, 2023
Insulin pump-makers grapple with questions about GLP-1s

Insulin pump-makers face questions about whether a new category of weight loss drugs will affect their long-term growth prospects. Companies including Insulet and Tandem Diabetes Care saw their stock prices fall after a small study showed that GLP-1 agonists — which include the branded drugs Ozempic, Wegovy and Mounjaro — allowed people with Type 1 diabetes to reduce or stop insulin injections. Shares of Insulet have declined 22% in the last month to $173.90, and shares of Tandem have declined 20% to $23.14. However, physicians surveyed by analysts were skeptical the drugs would change the long-term outlook for diabetes, noting that the study only included 10 patients who started GLP-1s within three months of being diagnosed. William Blair analyst Margaret Kaczor cited interviews with three physicians, including Insulet Medical Director Trang Ly, who all said there was no evidence GLP-1s reverse damage to the insulin-producing beta cells in the pancreas. ...
- Source: drugdu
- 101
- September 16, 2023
NYU Langone offers the highest-quality kidney and lung transplant programs in the nation, new U.S. data reveals

The NYU Langone Transplant Institute offers the highest-quality kidney and lung transplant programs in the nation, according to new federal quality data, while its heart and liver transplant programs hold the highest organ survival rates in New York. Data released this summer by the Scientific Registry of Transplant Recipients, a national quality tracker overseen by the U.S. Department of Health and Human Services, show NYU Langone’s kidney and lung transplant programs have achieved excellence in the most important triad of metrics: volume, transplant rate, and one-year survival. In 2022, NYU Langone transplanted 335 kidneys—the most of any center in New York State—while being the only high-volume program in the nation to achieve top-tier measures in both one-year organ survival and getting a deceased donor transplant faster. The kidney transplant program has the lowest mortality rate in New York City among those on the waitlist. Similarly, 81 lung transplants were performed ...
- Source: drugdu
- 103
- September 11, 2023
ECLS does not improve survival in patients with acute myocardial infarction complicated by cardiogenic shock

Early extracorporeal life support (ECLS) does not improve survival in patients with acute myocardial infarction complicated by cardiogenic shock who are scheduled for early revascularization, according to late breaking research presented in a Hot Line session today at ESC Congress 2023. Cardiogenic shock is the leading cause of death in hospitalized patients with acute myocardial infarction. Evidence-based treatment is limited to immediate revascularisation of the culprit lesion. However, mortality remains high, reaching 40-50% within 30 days. Ongoing efforts to improve outcomes have led to an increase in the use of active mechanical circulatory support devices to achieve hemodynamic stabilization in severe shock. In particular, the use of venoarterial extracorporeal membrane oxygenation (VA-ECMO), also called ECLS, has risen by more than 10 times in recent years. ECLS enables full circulatory and respiratory support, which differentiates it from other devices. However, evidence for ECLS in patients with cardiogenic shock and acute myocardial ...
- Source: drugdu
- 114
- August 30, 2023
Medtronic’s dialysis device recall assigned to Class I by the FDA

Dive Brief Medtronic’s recall of hemodialysis catheters was categorized by the U.S. Food and Drug Administration as a Class I event, according to a Friday entry in the FDA’s database. The company contacted customers in June after routine manufacturing testing identified a blockage that could obstruct the catheter, potentially delaying treatment and leading to outcomes such as blood clots and the destruction of red blood cells. Healthcare providers with devices covered by the recall should immediately quarantine and stop use of the catheters. Medtronic has received no confirmed complaints related to the problem, and no reports of adverse events or deaths. Dive Insight The Medtronic recall affects specific lots of Mahurkar Acute Triple Lumen Catheters and Mahurkar Acute High Pressure Triple Lumen Catheters. Medtronic’s Mahurkar Elite Catheters are unaffected by the recall. “Medtronic initiated a voluntary recall related to Mahurkar Acute Triple Lumen Catheters and Mahurkar Acute High Pressure Triple ...
- Source: drugdu
- 144
- August 18, 2023
Medtronic’s bid to dismiss heart device kickback claims fails, clearing case to advance

“This is a preliminary ruling in the case and Medtronic is confident that the full body of evidence, as the case moves ahead, will demonstrate that the claims have no merit. “Each patient seen at the Robert J. Dole VA Medical Center for a Peripheral Arterial Disease interventional procedure was referred by other doctors because of the patient’s medical condition. Moreover, the physicians performing these procedures used FDA-approved devices from a variety of manufacturers and the physicians were salaried and received no additional compensation for the procedures or using the devices. “Medtronic follows all applicable laws and policies to ensure our interactions with physicians are principled and appropriate.” Dive Brief Medtronic’s attempt to dismiss whistleblower accusations that it violated the False Claims Act has largely failed, with a court ruling on Thursday that most of the claims can advance. The whistleblower accused Medtronic of billing the government for unnecessary medical ...
- Source: drugdu
- 234
- August 17, 2023
analysts

Dive Brief Analysts at Needham expect a U.S. Food and Drug Administration advisory panel to support the safety and efficacy of Medtronic’s renal denervation device at a meeting later this month. The meeting, which the FDA scheduled in June, will enable experts in circulatory system devices to discuss the evidence on Medtronic’s Symplicity Spyral and ReCor Medical’s rival renal denervation system. While the analysts expect Medtronic to face questions over the failure of its pivotal trial, they think the experts will vote in favor of the device, putting it on track to target a $1 billion-plus market. Dive Insight Medtronic’s multi-year effort to build confidence in renal denervation as a way to treat high blood pressure hit a snag late last year when a pivotal trial found it worked no better than drugs alone at reducing patients’ blood pressure at home. However, while the missed endpoint was an unwelcome development ...
- Source: drugdu
- 171
- August 9, 2023
FDA Adopts New Sterilization Standard to Support Switch From Ethylene Oxide

Dive Brief The U.S. Food and Drug Administration has adopted an international sterilization standard to give medical device manufacturers another alternative to ethylene oxide (EtO). Manufacturers can now make declarations of conformity to the International Organization for Standardization’s recommendations on low-temperature vaporized hydrogen peroxide in submissions to the FDA. The FDA framed the addition of the ISO test to its Recognized Consensus Standards database as a response to pressure to reduce EtO use and the need to support supply chain resiliency. Dive Insight In April, the U.S. Environmental Protection Agency proposed limiting EtO emissions from sterilization facilities by 80% to minimize the risk of people developing cancer from exposure to the gas. AdvaMed has warned the limit could halve capacity at commercial sterilizing plants, and the FDA has cautioned that there is a lack of viable alternatives to EtO for many devices. The ...
- Source: drugdu
- 144
- July 28, 2023
BD Gains FDA Clearance to Relaunch Alaris Infusion Pump After Recalls

Dive Brief The Food and Drug Administration has granted Becton Dickinson 510(k) clearance for its updated Alaris infusion pump, paving the way for the company to begin distributing the system again and to remediate or replace all older versions of the device in the field, BD said Friday. The FDA’s green light comes two years after the company filed a new submission for modifications to the pump, which delivers medications and other fluids intravenously to patients, following a series of recalls due to system malfunctions. A large installed base of Alaris systems remains in hospitals. BD said it will address all recall requirements still open to bring those devices into compliance with the FDA clearance, including hardware, software and cybersecurity updates. Dive Insight Widely used in healthcare, infusion pumps from a number of manufacturers have been among the devices that frequently appear on the ...
- Source: drugdu
- 245
- July 27, 2023

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