Boston Scientific Corp.’s Watchman, designed to help prevent strokes in patients with an erratic heartbeat, may be a tougher sell for U.S. regulators after a study failed to confirm the device’s benefit.
Boston Scientific Corp.’s Watchman device, designed to help prevent strokes in patients with an erratic heartbeat, was safer than previously thought in a second study requested by U.S. regulators, researchers said.
Boston Scientific Corp.’s study of a heart device to reduce stroke risk, slated for presentation at a medical heart meeting this weekend, is under review after the company said only limited data about the product’s safety would be released.
St. Jude Medical Inc. recalled a new delivery system used to treat people with a dangerous hole in the heart after discovering the device could fracture in a small number of cases, U.S. regulators said.
Patients with early Parkinson’s disease who respond to drug therapy gain improvement in their symptoms and quality of life when they receive deep-brain stimulation from an implanted medical device, a study showed.
Volcano Corp.’s test that shows which patients need heart stents could lead to a $2 billion market within a decade as more doctors use it to improve care, Chief Executive Officer Scott Huennekens said.
Brainsway Ltd. expects to reach an agreement this quarter for a medical-device company to market its non-invasive system to treat depression in the U.S., Chief Executive Officer Uzi Sofer said. The stock rose to the highest in almost three years.
St. Jude Medical Inc., a maker of devices for irregular heartbeats, said it received a warning from U.S. regulators last week for deviating from unspecified good manufacturing practices at its Sylmar, California, plant.