Abbott (NYSE:ABT) and Medtronic (NYSE:MDT) today announced separate data-sharing deals for digital diabetes management solutions. Abbott is partnering with Sanofi (NYSE:SNY) to integrate glucose sensing and insulin delivery to help people manage their diabetes. The two companies plan to develop tools to combine Abbott’s FreeStyle Libre technology with insulin dosing information for smart pens, insulin titration apps and cloud software. […]
Abbott wins FreeStyle Libre reimbursement in Ontario, Quebec
Abbott (NYSE:ABT) said today that it has won public reimbursement in Ontario and Quebec for its FreeStyle Libre sensor-based glucose monitoring system — the first of its kind listed by any provincial health plan in Canada. FreeStyle Libre is designed to monitor glucose levels with a small sensor on the back of the upper arm […]
Trial will pit Nobles Medical’s PFO tech against Abbott’s for stroke reduction
The FDA has granted Nobles Medical Technologies II approval to conduct a prospective pivotal clinical trial for the expanded indication of patent foramen ovale (PFO) closure for reduction of recurrent ischemic stroke, according to the company. The FDA cleared the NobleStitch EL for cardiovascular suturing in April 2017. It was CE marked in Europe for […]
Abbott launches U.S. pivotal trial for TriClip tricuspid repair device
Abbott (NYSE:ABT) said today that it’s launching another study of its TriClip tricuspid valve repair device, this time aimed at winning U.S. regulatory approval. The five-year, 700-patient Triluminate pivotal trial, under an investigational device exemption from the FDA, is the first such study of a transcatheter, non-surgical treatment for patients with severe tricuspid regurgitation, Abbott […]
ESC Congress: Study shows bariatric surgery can improve cardiac outcomes in Type 2 diabetes
Bariatric or metabolic surgery can significantly lower the risk of major cardiovascular events among patients with Type 2 diabetes and obesity, according to a new clinical study released at the European Society of Cardiology Congress in Paris. The retrospective study followed 13,722 Type 2 diabetes patients who underwent bariatric surgery to lose weight or metabolic […]
Surmodics reaps $10m from Abbott on SurVeil balloon milestone
Surmodics (NSDQ:SRDX) said today that it’s due for a $10 million milestone payment from Abbott (NYSE:ABT) after closing enrollment for the Transcend pivotal trial of its SurVeil drug-coated balloon for treating peripheral artery disease. Abbott in February 2018 paid $25 million up front for the global commercialization rights to the SurVeil device, which uses a proprietary […]
Abbott’s MitraClip may win expanded Medicare coverage
Abbott’s (NYSE:ABT) MitraClip heart valve device may secure Medicare coverage for an additional procedure. The Center for Medicare and Medicaid Services (CMS) announced yesterday that it will study whether to extend coverage of the MitraClip transcatheter mitral valve repair (TMVR) device in cases of secondary mitral regurgitation, which results from left ventricular dysfunction. Medicare already pays […]
Ex-Oriole DeCinces draws time served on insider trading conviction
A federal judge in California reportedly sentenced former professional baseball player Doug DeCinces to time served this week after his conviction on insider trading charges related to the $2.8 billion acquisition of Advanced Medical Optics by Abbott (NYSE:ABT) in 2009. Federal prosecutors in 2014 accused ex-AMO CEO James Mazzo of tipping former Orioles and Angels player […]
FDA slaps Abbott ICD recall with Class I label
The FDA has labeled a recent Abbott (NYSE:ABT) recall of Ellipse implantable cardioverter defibrillators (ICDs) as the most serious type, which could result in patient death. The company began the recall in June, citing damaged wires in 204 Ellipse pacemakers distributed globally. Today’s FDA announcement said that a faulty manufacturing process had left the Ellipse […]
Humana sues Abbott’s St. Jude Medical over CRM batteries
Humana (NYSE:HUM) leveled a lawsuit against Abbott (NYSE:ABT) subsidiary St. Jude Medical seeking to recoup payments it made for cardiac rhythm management devices that were later recalled due to a battery issue. In October 2016 St. Jude publicly revealed the risk that the lithium-based batteries used in its implantable cardioverter defibrillators and cardiac resynchronization therapy […]
The 17 most innovative medical devices of 2019
The Galien Foundation recently announced nominees for most innovative medical devices for its 13th Annual Prix Galien USA Awards. The foundation awards the Prix Galien Award annually to examples of outstanding biomedical and technology product achievements that are designed to improve human condition. Nominees need to be FDA approved for market within the last five […]
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