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.
The San Diego, CA-based company will pay about $750 million to help expand its out-of-hospital software portfolio.
The San Diego, CA-based company is set to acquire its rival PacificBio in a deal valued at $1.2 billion.
The Madison, WI-based company said its test can identify metabolic subtypes associated with the Autism Spectrum and can be used to screen children as young as 18 months.