Medtronic is the undisputed leader of the drug-coated balloon space, but Philips is vying for an indication that could potentially impact the Dublin-based firm’s hold on the market.
The release of the ST LEUIS trial data comes on the heels of Apple receiving FDA clearance for an ECG app for the Apple Watch.
The Danvers, MA had strong data at the American Heart Association, however the firm’s shares were down as much as 17% on Monday.
The London-based company’s bioconvertible IVC filter had zero instances of tilt, perforation, migration and embolization through follow-up in the SENTRY trial.
The Santa Clara, CA-based company filed its PMA submission with FDA earlier this year and hopes to be able to launch the technology in the first half of 2019.
The Louisville, CO-based company has raised $7.5 million and will use the new capital to help with regulatory approval and the commercial launch of the system.
The Dublin-based company has received FDA approval to begin a clinical trial to evaluate the Symplicity Spyral renal denervation system with patients on medication for high blood pressure.
The San Diego-based company brought in about $266.7 million in revenue vs. the consensus estimate of $241.3 million.
FDA has given approval for the Germantown, MD-based company’s device to be inserted by qualified nurse practitioners and physician assistants.
The Redwood City, CA-based company spent about $3.5 million in its patent dispute with Boston Scientific during 3Q18.
The Bedford, MA-based company received a nod from FDA for the IRIS upgrade for the NvisionVLE Imaging System, which is used in the imaging of esophageal tissue.
Intuitive Surgical has been dominant in surgical robotics for years now, but Medtronic and Verb both have systems that are on the horizon and will be in direct competition with the da Vinci, said Roger Smith, who follows the space closely.