Search Results for “Medtronic” – Page 7 – media

Senseonics gets FDA clearance to pair CGM implant with insulin pumps

Dive Brief Senseonics has received an integrated continuous glucose monitoring (iCGM) designation from the Food and Drug Administration, the company said Tuesday. The designation, which the FDA granted via its de novo pathway, clears Senseonics to integrate its implantable CGM with pumps as part of automated insulin delivery systems. Senseonics’ sales are small compared to the CGM leaders Abbott and Dexcom, but BTIG analysts said the iCGM designation and planned one-year sensor could help the device appeal to a broader patient population. Dive Insight Senseonics’ Eversense device is a CGM implant that replaces fingerstick blood glucose measurements. The current device continually measures glucose levels for up to 180 days but requires daily calibrating with a fingerstick after day 21 and when symptoms do not match CGM information. Abbott and Dexcom sell shorter-lasting patches that dominate the CGM space. The iCGM designation allows Eversense to integrate with ...
- Source: https://www.medtechdive.com/news/senseonics-fda-clearance-integrated-cgm/714804/
- 80
- May 3, 2024
Abbott’s latest Heartmate recall tied to 273 injuries, 14 deaths

Dive Brief Abbott is recalling thousands of Heartmate II and Heartmate 3 left ventricular assist systems because biological material can build up and obstruct the devices, making them less effective at pumping blood, the Food and Drug Administration said Monday. Reports of 273 injuries and 14 deaths have been linked to the problem, with the material typically taking two or more years to accumulate, according to the recall notice. The FDA identified the action as a Class I recall, the most serious type. Heartmate devices are used to support patients with severe left ventricular heart failure who are awaiting a heart transplant, or the device can be permanently implanted when a transplant isn’t an option. In February, Abbott told customers in an urgent correction letter there is no need to return any products to the company. Dive Insight Heartmate devices take over the pumping function of the left ventricle, the ...
- Source: drugdu
- 113
- April 17, 2024
Intuitive lands FDA clearance for new da Vinci robot

Dive Brief Intuitive Surgical said Thursday it received 510(k) clearance from the Food and Drug Administration for a fifth-generation robotic surgery system intended to help the company keep its dominant market share in the face of looming competition. The da Vinci 5 system incorporates features that surgeons have long sought, such as feedback that simulates the feel of the patient’s body tissue, a smaller physical footprint in the operating room, and better console ergonomics. The improvements “can help drive incremental demand for the system and raise the bar for competition in the future,” William Blair analyst Brandon Vazquez said Friday in a note to clients. Dive Insight Intuitive is preparing for competitive challenges from Medtronic and Johnson & Johnson, as well as a wave of startups hoping to vie for a piece of the growing market. The robot maker, which saw its procedure volumes increase by 21% in the fourth ...
- Source: drugdu
- 131
- March 18, 2024
Insulet applauds NICE guidance on hybrid closed loop insulin delivery

BY SEAN WHOOLEY The Omnipod 5 hybrid closed-loop insulin delivery system worn on the back of an arm. [Image courtesy of Insulet] Insulet (Nasdaq:PODD) supports new National Institute for Health and Care Excellence (NICE) guidance supporting automated insulin delivery for type 1 diabetes. NICE published guidance recommending hybrid closed-loop systems for eligible people with type 1 diabetes in England and Wales. Hybrid closed-loop systems, like the Insulet Omnipod 5, deliver insulin automatically based on calculations from glucose monitors. Medtronic, Tandem Diabetes Care and Beta Bionics also compete with Insulet in the automated insulin delivery space. Medtronic applauded automated insulin delivery recommendations from NICE last month. NICE’s guidance, published this week, outlines that the systems require less input from the user, but manual insulin dosing is still needed sometimes, for example, around mealtimes. So, they may reduce the mental burden and improve people’s quality of life. In a LinkedIn post from ...
- Source: drugdu
- 97
- January 1, 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
- 186
- December 30, 2023
J&J’s Biosense Webster treats first patients in dual-energy AFib ablation trial

BY SEAN WHOOLEY The ThermoCool SmartTouch dual-energy ablation catheter could offer a treatment option for AFib. [Image courtesy of Biosense Webster]Johnson & Johnson’s Biosense Webster today announced the first completed patient cases in a study of its dual-energy ablation catheter. Biosense Webster designed the ThermoCool SmartTouch SF to deliver both radiofrequency (RF) and pulsed-field ablation (PFA) energy. The SmartPulse pivotal study evaluates the dual-energy system in the treatment of paroxysmal AFib. AFib ablation has become a hotbed for innovation in recent years. Medtronic stands as one competitor after its $1 billion Affera acquisition, plus the FDA yesterday approved its PulseSelect PFA system for treating AFib. Boston Scientific and its Farapulse system represent another exciting option in the space. The company expects FDA approval sometime next year. Dr. David Newton of Memorial Health University Physicians Heart Care and Dr. Andrea Natale of Texas Cardiac Arrhythmia Institute, St. David’s Medical Center, performed ...
- Source: drugdu
- 592
- December 18, 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
- 148
- December 5, 2023
J&J links radiofrequency catheter to improved quality of life in atrial fibrillation study

Dive Brief Johnson & Johnson has linked its Qdot Micro radiofrequency (RF) catheter to improved quality of life in patients with paroxysmal atrial fibrillation (AFib). The single-arm study found that, compared to baseline, scores on an AFib quality-of-life scale improved and use of antiarrhythmic drugs fell after people underwent treatment with the device. Qdot Micro, which received approval in the U.S. in 2022, is set to face competition from pulsed field ablation (PFA) devices. A Boston Scientific study suggests PFA and thermal ablation result in similar levels of improvement in quality of life. Dive Insight Qdot Micro is temperature-controlled, contact force-sensing, RF catheter. The temperature control feature supports the use of higher radiofrequency power in short bursts, an approach that J&J sees as a way to improve efficacy without compromising safety. J&J published 12-month data on the effectiveness of the device in its Q-FFICIENCY study earlier this year. The latest ...
- Source: drugdu
- 100
- November 9, 2023
analysts

Dive Brief Johnson & Johnson’s spinoff of its consumer health business has positioned the company to achieve top-tier medtech growth and profitability, according to analysts at RBC Capital Markets. J&J recently split off its consumer health unit to make a standalone company, turning itself into the only global healthcare company with pharma and medtech in a single portfolio. RBC analysts expect the new structure to support the growth of a “bellwether” healthcare stock. On the medtech side, the analysts identified J&J’s leadership position in 11 categories, shift to fast-growing markets, investment in robotics and capacity for M&A as factors that position it to outperform its peers. Dive Insight The RBC analysts praised J&J’s current medtech portfolio, noting that the company is a leader in 11 categories and has 12 platforms with sales of more than $1 billion. The portfolio is the result of a “clear winning strategy,” they wrote in ...
- Source: drugdu
- 164
- October 11, 2023
Should More Doctors Be on TikTok? This One Says Yes

Gastroenterologist Dr. Austin Chiang has about a decade of experience as a physician influencer on social media. During a conference in Chicago, he encouraged more providers to share their expertise on social media. By having a presence on these platforms, healthcare professionals demonstrate their commitment to meeting patients where they are, he said. By KATIE ADAMS As a gastroenterologist, Dr. Austin Chiang has witnessed plenty of patients get admitted to the hospital after taking unvetted medical advice they found on the Internet, he said Wednesday during an interview at Oliver Wyman’s Health Innovation Summit in Chicago. About 10 years ago, Dr. Chiang took to social media to address this issue by being a credible source for health information. At the time, many of his colleagues thought this was a waste of time — but he has since proved them wrong. He now has nearly 750,000 followers across his TikTok, YouTube, ...
- Source: drugdu
- 220
- October 3, 2023

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