EBR Systems said today that it raised a $30 million funding round and tapped ex-Ceterix Orthopaedics CEO John McCutcheon to be its new chief executive. The Sunnyvale, Calif.-based company is developing the Wise wireless pacemaker, designed to use a subcutaneous generator to wirelessly deliver ultrasound energy to a “pellet” implanted in the right ventricle to […]
Zoll closes Cardiac Science buyout
Asahi Kasei (TYO:3407) subsidiary Zoll Medical said today that it closed its deal to acquire Cardiac Science and its portfolio of automated external defibrillators for an undisclosed amount. Deerfield, Wis.-based Cardiac Science operates in North America, Europe and Asia. The company has installed more than 500,000 units in nearly 100 countries, according to Zoll. “This acquisition […]
Boston Scientific warns on battery risk with some older Emblem S-ICDs
A small group of older Boston Scientific (NYSE:BSX) subcutaneous implantable cardioverter defibrillators have an increased risk of early battery depletion, the company said this month in an advisory letter to physicians. The Marlborough, Mass.-based company said the issue affects about 400 (0.7%) of its Emblem S-ICD and Emblem MRI S-ICD devices. Those devices have “an elevated […]
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 […]
Zoll warns on AED Pro defibrillator issue
Asahi Kasei (TYO:3407) subsidiary Zoll Medical this month issued a field advisory for its AED Pro automated external defibrillator after receiving a report that a unit failed during use. Chelmsford, Mass.-based Zoll said its investigation traced the problem to an “isolation breakdown” on an area of the AED Pro’s internal circuit board. “If the isolation breakdown […]
Acutus Medical reels in $170m
Acutus Medical said today that it pulled down $170 million in financing from its Series D offering and a new credit line for the cardiac mapping technology it developed. In addition to its AcQMap tech to aid in ablation treatment of arrhythmias, Carlsbad, Calif.-based Acutus makes a line of vascular access products. It’s latest financing […]
Philips wins PMAs for OTC automated external defibs
Royal Philips (NYSE:PHG) said today the it won pre-market approval from the FDA for a pair of its automated external defibrillators, more than four years after the federal safety watchdog said it would require PMAs for AEDs that had already won 510(k) clearance. The Dutch healthcare conglomerate said the FDA granted PMAs for its already-cleared […]
HRS 2019 Roundup: Medtronic touts extravascular ICD pilot
The pilot study of an extravascular implantable cardiac defibrillator developed by Medtronic (NYSE:MDT), which is designed to deliver both defibrillation and anti-tachycardia pacing using leads placed outside the heart and venous system, showed strong safety and efficacy results. The safety outcome for the 26-patient study, presented last week at the annual meeting of the Heart […]
Acutus Medical acquires Rhythm Xience
Acutus Medical said today that it agreed to acquire Rhythm Xience for an undisclosed amount and inked deals with a trio of new partners. Eden Prairie, Minn.-based Rhythm Xience makes a line of transseptal crossing and steerable introducer systems including the Flextra, Guider and Lancer devices, which are all 510(k)-cleared by the FDA. “At Acutus, we […]
FDA warns of battery depletion issue with Medtronic pacers
A problem with the batteries in certain pacemakers made by Medtronic (NYSE:MDT) led to at least one death and one injury, the FDA said today. The issue, which affects the Azure and Astra pacemakers and Percepta, Serena and Solara cardiac resynchronization therapy pacemakers, occurs when a ceramic capacitor cracks internally due to thermal-mechanical stress during […]
Medtronic wins FDA approval for CareLink SmartSync CRM device manager
Medtronic (NYSE:MDT) said today that it won pre-market approval from the FDA for the CareLink SmartSync device manager for use with its cardiac rhythm management devices. The approval gives the ability to use Apple iPads to program and manage data from pacemakers enabled with Medtronic’s BlueSync and an app that allows its Azure, Percepta, Serena, […]
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