Search Results for “Medtronic” – Page 2 – media

Medtronic expands AI endoscopy partnership with Cosmo

Dive Brief Medtronic will pay Cosmo Intelligent Medical Devices $100 million upfront to expand a partnership that makes Medtronic the exclusive global distributor of Cosmo’s GI Genius platform. GI Genius received de novo clearance in 2021 and uses machine learning to flag regions of interest during a colonoscopy, helping physicians detect lesions, such as polyps or suspected tumors. In addition, Medtronic said it would pay a double-digit royalty on net sales and another $100 million in milestone payments that it expects the partnership to reach by the end of 2024. Dive Insight Medtronic first started working with Cosmo Intelligent Medical Devices, a subsidiary of Cosmo Pharmaceuticals, in 2019. When the Food and Drug Administration cleared GI Genius a few years later, the agency said it was the first device that used machine learning to help clinicians detect lesions in the colon. Now, Cosmo and Medtronic are expanding their partnership, including ...
- Source: drugdu
- 97
- December 13, 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
- 172
- November 30, 2023
FDA deems stolen Medtronic scopes problem a Class I recall

BY SEAN WHOOLEY Conforming devices can be identified by their serial number. The FDA today issued a notice saying the recall of Medtronic (NYSE: MDT)+ McGrath Mac video laryngoscopes is Class I, the most serious kind. Medtronic in October warned on stolen, defective McGrath Mac video laryngoscopes offered for sale by unauthorized third parties. The company initiated a recall as a result of the stolen, defective products. The company informed the public of the illegal offering of the devices by third parties through various social media platforms. Affected products failed to pass Medtronic’s rigorous tests established for the product. The company did not release them for sale, distribution or importation. Potential adverse effects from defective scopes include hypoxia, hypercapnia, tissue damage/trauma and/or a delay to treatment. More details on the Medtronic recall The recall affects 5,709 devices in the U.S., distributed between July 5, 2019, and July 14, 2022. Medtronic’s ...
- Source: drugdu
- 98
- November 15, 2023
Medtronic in exclusive talks for $7B sale of units to private equity

Dive Brief The private equity firm Carlyle Group is leading the race to buy Medtronic’s connected patient monitoring and respiratory care operations, according to Reuters. Medtronic outlined plans to spin off the units almost one year ago. At the time, the company proposed creating a new connected care company, but the move reportedly led to interest from potential buyers including Siemens Healthineers and GE HealthCare. Now, with Medtronic nearing the end of its targeted window for completing a transaction, Reuters has reported that Carlyle has entered into exclusive negotiations to buy a majority stake in the two businesses at a valuation of more than $7 billion. Dive Insight Patient monitoring and respiratory interventions, part of Medtronic’s Medical Surgical portfolio, are among the slower-growing parts of the company. While neither business has the type of growth profile that Medtronic is targeting, they could be attractive to another company. According to Reuters, ...
- Source: https://www.medtechdive.com/news/medtronic--7b-deal-private-equity-carlyle-group/695282/
- 224
- October 3, 2023
Medtronic sued for allegedly sharing ‘treasure trove’ of diabetes patient data with Google

Dive Brief A plaintiff has accused Medtronic of sharing user data for its InPen diabetes management system with companies including Google. The lawsuit alleges that Medtronic’s MiniMed business used digital platforms to acquire “a treasure trove of personal data” and shared the information with third parties to increase revenue and profits. According to the plaintiff in the proposed class action lawsuit, the disclosures to Google are “particularly problematic” because his use of Gmail meant his personal information was “automatically linked to his real identity.” Dive Insight The case centers on the app that accompanies Medtronic’s smart insulin pen. Medtronic created the app to help patients record their insulin doses, receive reminders and share data with their healthcare team. The use of the data is covered by Medtronic’s notice of privacy practices. According to the lawsuit, the company has used the data in ways that are beyond the terms covered in ...
- Source: drugdu
- 119
- September 7, 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
- 146
- 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
- 235
- 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
- 172
- August 9, 2023
Can CorWave Fill Medtronic’s Shoes in the LVAD Market?

Medtronic’s exit from the left ventricular assist device (LVAD) market left a huge void. A small French company wants to fill it. A small French company has some mighty big shoes to fill in the left ventricular assist device (LVAD) market. When Medtronic pulled the plug on its embattled HeartWare ventricular assist device in 2021, the departure created a significant void in the LVAD market and highlighted the urgent need for innovation in the space to improve outcomes for end-stage heart failure patients. Abbott said it had the capacity and supply to effectively support the growing demand for mechanical circulatory support devices with its HeartMate 3 device, but Abbott and other LVAD makers suffer from limitations of using rotary pump technology, according to CorWave CEO Louis de Lillers. Clichy, France-based CorWave is developing an implantable heart pump for advanced heart failure patients that is based on a technology called ...
- Source: drugdu
- 99
- July 15, 2023
Medtronic Secures Medicare Coverage for MiniMed 780G Insulin Pump

Dive Brief Medtronic has received Medicare and Medicare Advantage coverage for its recently approved MiniMed 780G insulin pump. The company said on Thursday that it has begun processing orders and will start shipping devices to patients with Type 1 diabetes who meet the eligibility criteria over “the next few weeks.” The coverage clears a barrier to patient access for a pump that is central to Medtronic’s plans to kickstart growth at its diabetes business after a tough period defined by regulatory problems. Dive Insight The U.S. Food and Drug Administration approved the 780G pump in April. Medtronic had aimed to bring the device to the U.S. market sooner, but its plans were delayed by a warning letter, hindering its ability to compete with Insulet and Tandem Diabetes Care in the insulin pump market. With the device now approved for use, Medtronic is working to ensure patients ...
- Source: drugdu
- 140
- July 13, 2023

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