King Systems announced that it initiated a voluntary recall of 171 units of its King Vision video laryngoscope adapter size 1/2 because of an issue where the device exhibits a reversed image. Any product that displays a reversed image could potentially cause difficulty navigating during intubation and/or a delay in intubation, according to an FDA […]
Strata Skin Sciences wins FDA clearance for excimer laser platform
Strata Skin Sciences (NSDQ:SSKN) announced that it won FDA 510(k) clearance for its Xtrac Momentum excimer laser system for treating a number of skin diseases. The Xtrac laser is designed to deliver a highly targeted therapeutic beam of UVB light in the treatment of psoriasis, vitiligo, eczema, atopic dermatitis and leukoderma. It is made in three […]
FDA grants Medtronic an IDE to study new tech for ablating heart tissue
Medtronic (NYSE:MDT) announced today that it won FDA approval to move forward with an investigational device exemption trial to evaluate the safety and effectiveness of its PulseSelect pulsed-field ablation (PFA) system. The PulseSelect system is designed to use the pulsed electric fields to treat atrial fibrillation (Afib). It uses the fields to ablate or create lesions […]
Certain GE Healthcare patient-monitoring devices vulnerable to cyberattack
The federal government and GE Healthcare (NYSE:GE) announced today that the certain of the company’s patient monitoring devices are vulnerable to cyberattack. If attacked, some versions of the Carescape and ApexPro telemetry servers, the Carescape Central Station version 1 and Central Information Center systems could stop monitoring patients, silence alarms or produce unnecessary alarms during […]
Cardinal Health recalls 9 million surgical gowns, sends hospitals scrambling
Cardinal Health (NYSE:CAH) announced that it is voluntarily recalling 9.1 million surgical gowns produced by an unnamed contract manufacturer after discovering quality issues with the product. The Dublin, Ohio-based company said that some gowns were produced in unapproved locations that did not maintain proper environmental conditions as required by law. Some of the gowns were also […]
Teleflex wins FDA clearance for Wattson temporary pacing guidewire
Teleflex (NYSE:TFX) announced today that it won FDA 510(k) clearance for its Wattson temporary pacing guidewire for use during transcatheter aortic valve replacement (TAVR) and balloon aortic valvuloplasty (BAV). The Wattson guidewire is designed to simplify and shorten procedures by eliminating the need for the routine use of central venous access and transvenous temporary pacing […]
Ra Medical Systems wins FDA’s OK to study new uses for Dabra system
Ra Medical Systems (NYSE:RMED) announced today that it won investigational device exemption approval to study use of its Dabra excimer laser system as an atherectomy device to treat peripheral vascular stenoses. The Dabra system is designed to destroy arteriosclerotic blockages through the use of radiation ablation. The system won FDA 510(k) clearance in May 2017 for the […]
Axonics wins FDA approval for enhanced neurostimulator programmer
Axonics Modulation Technologies (NSDQ:AXNX) announced today that it won FDA approval for a second-generation programmer for its r-SNM sacral neuromodulation system. The Irvine, Calif.–based company’s new programmer is designed to program the Axonics external trial neurostimulator and the implantable neurostimulator in the procedure and post-operative environments, according to a news release. The device is a touchscreen […]
FDA reclassifies some medical image analyzers
The FDA today imposed stricter regulations on certain radiological medical image analyzers, reclassifying them from Class III to Class II. Affected products include computer-assisted detection (CADe) devices for breast cancer mammography, breast-lesion ultrasound, and lung-nodule and dental-caries radiography, the agency said. It defines these devices as those intended to identify, mark, highlight, or in any […]
Cardinal Health has a surgical gowns contamination problem
The FDA announced that it is working to assess quality issues surrounding surgical gowns and the PreSource procedural packs that contain them, all produced by Cardinal Health (NYSE:CAH). Both Dublin, Ohio–based Cardinal Health and the FDA agree that customers should immediately discontinue the use of all affected gowns and the packs that include them because the […]
FDA to EPA: Leave us out of your ethylene oxide rule
This article has been updated with comments from the FDA. The FDA has asked the Environmental Protection Agency to leave the FDA out of its proposal for stricter regulation of ethylene oxide (EtO) emissions, and the EPA complied. In an interagency comment on the EPA’s proposed rule governing commercial EtO users — which includes medical device sterilization plants — […]
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