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, […]
Boston Scientific touts Luminize catheter study
Boston Scientific (NYSE:BSX) this week touted results from a study of a single-shot ablation catheter for atrial fibrillation at a European cardiac rhythm conference. The Marlborough, Mass.-based medical device giant said the 100-patient AF-ficient I study of intermittent AF proceeded in two stages. Phase one, testing the original Luminize design, showed a pulmonary vein isolation rate […]
Cardialen raises $17m Series B
Cardialen said today that it closed a $17 million Series B round for the low-energy defibrillation technology it’s developing. The Minneapolis-based company said RiverVest Venture partners led the round, joined by Qiming Venture Partners, HBM Healthcare Investments and Cultivation Capital. The proceeds are earmarked for further clinical work on Cardialen’s “unpinning termination” therapy, which is designed to […]
AtaCor Medical raises $9m for sub-sternal pacer
AtaCor Medical said today that it raised nearly $9 million in a Series A round for the sub-sternal pacemaker it’s developing. San Clemente, Calif.-based AtaCor said Broadview Ventures and aMoon Ventures co-led the $8.8 million round, joined by an unnamed “corporate partner.” The proceeds are earmarked for further development of the pacer system. The device is designed to […]
Abbott’s St. Jude Medical must face negligence suit over Riata leads
Abbott (NYSE:ABT) subsidiary St. Jude Medical must face a negligence lawsuit brought over its recalled Riata defibrillator leads after a federal judge ruled that the case is not pre-empted by federal rules. Plaintiff Kristen Bull was implanted with a St. Jude implantable cardioverter defibrillator using Riata leads in November 2010, just a month before the company pulled the […]
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