Verily, Google’s life science’s sister company under Alphabet (NSDQ:GOOGL), has received an FDA 510(k) clearance to include an irregular pulse monitor in its Study Watch wearable. The FDA announcement, last updated Jan. 20, did not include additional information. The agency cleared ECG capabilities on the Study Watch in January 2019. Launched in April 2017, the Study […]
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
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 […]
BREAKING: Medtronic wins FDA approval for Micra AV
Medtronic (NYSE:MDT) has won FDA approval for its Micra AV — greatly expanding the number of people who could potentially benefit from leadless pacemaker technology. The medical device giant plans to start offering the Micra AV in a limited number of implanting centers in the coming weeks, with a full launch expected in the spring. FDA […]
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 […]
Medline Industries temporarily halts EtO sterilization at Illinois plant
This article has been updated with a comment from Medela. Medline Industries has temporarily closed its Waukegan, Ill., medical device sterilization operation to install nearly $10 million in emissions upgrades. The privately owned company uses the carcinogenic gas ethylene oxide (EtO) to sterilize its own and other companies’ devices at the plant. Medline did not […]
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 […]
Getinge issues urgent field safety notice for 88-series
Getinge (STO:GETI-B) issued an urgent field safety notice in Europe to warn customers of a potential leakage issue with its 88-5 washer disinfector. According to the safety notice out of Germany, the leakage may occur from the device in ruptured spot welds in the chamber, in some instances due to a worn door seal. 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 — […]
Medtronic issues urgent field safety notice for O-arm imaging system
Medtronic (NYSE:MDT) announced that it determined that a replacement of the internal gantry tractor motor drive will resolve an issue with the O-arm O2 imaging system that the company warned customers of last year. In November, Medtronic notified customers of the potential for navigational inaccuracy with the O-arm O2 system’s auto-registration feature when used in conjunction […]
Gore announces some Excluder problems in Europe
W.L. Gore & Associates issued an urgent field safety notice in Europe to warn on issues with its Excluder AAA Endoprosthesis and Excluder Iliac Branch. Both Excluder products may experience the separation of the leading end of catheter components, according to the safety notice out of Germany. From January 2013 to Aug. 5, 2019, Gore […]