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 […]
Spacelabs, OrthoScan win DoD contracts
Spacelabs Healthcare and OrthoScan have won contracts worth $450 million and $125 million, respectively, from the U.S. Department of Defense to supply it with medical-related equipment and services, according to a recently posted DoD press release. Snoqualmie, Wash.-based SpaceLabs won its $450 million firm-fixed-price, indefinite-delivery/indefinite/quantity contract to supply the defense agency with patient monitoring systems, […]
SpaceLabs’ Arkon anesthesia system recalled again
The FDA has slapped SpaceLabs Healthcare with a Class 1 recall of its Arkon anesthesia delivery system for going into a “failed state” on numerous occasions since 2013. The recall covers 253 units. No injuries or deaths were reported. During the failed state, the mechanical ventilation function stops working while the machine is in use […]
Endo Health warned by FDA on AMS pelvic mesh plant | Medtech regulatory news for the week of Apr. 21, 2014
Another recall for Spacelabs Healthcare’s Arkon anesthesia system
The FDA slapped Spacelabs Healthcare with a Class I recall after the medical device company pulled 16 of is Arkon anesthesia delivery devices due to a software bug.
The recall, of the Arkon device equipped with version 2.0 software, involves devices sold to hospitals in North Carolina and South Carolina, according to the FDA. The Class I recall status denotes a problem that could cause serious injury or death.
Recall: Spacelabs Healthcare pulls anesthesia workstations over excess CO2 risk
Washington-based Spacelabs Healthcare recalled a slate of its Spacelabs BleaseSirius and BleaseFocus anesthesia workstations as well as certain absorbers contained in service kits over concerns that they may contain a defect which could result in excess carbon dioxide in the gas delivered to a patient.
More warnings on metal-on-metal hip implants in U.K, New Zealand | Regulatory Roundup
GPOs: Novation and Premier tout new deals
Hospital group purchasing organizations Novation and Premier signed new contracts this week, covering patient monitoring solutions, intra-aortic balloon catheters and pumps.
Novation awarded a three-year contract to Spacelabs Healthcare, a subsidiary of OSI Systems Inc. (NSDQ:OSIS), for patient monitoring and connectivity solutions.
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