By Stewart Eisenhart, Emergo Group
New laws setting up a formal regulatory system for medical devices have been approved by the Malaysian government, according to Med/Cert.
The Medical Device Business Journal — Medical Device News & Articles | MassDevice
By Stewart Eisenhart, Emergo Group
New laws setting up a formal regulatory system for medical devices have been approved by the Malaysian government, according to Med/Cert.
Boston Scientific (NYSE:BSX) launched its next-generation Promus Element Plus drug-eluting stent in Canada following approval from regulators this week.
The Promus Element Plus, built on the Promus Element stent design, features a modified catheter delivery system, according to a press release.
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Med-tech titan Boston Scientific (NYSE:BSX) landed CE Mark approval for its Emerge PTCA dilation catheters, announcing immediate commercial launch on the European market.
Abbott (NYSE:ABT) said it won approval from the Japanese Ministry of Health, Labor and Welfare for its next-generation Xience Prime coronary stent
The nod means the cobalt-chromium stent is "available in all of the major markets worldwide," according to a press releaase, including the U.S., Europe, China and India.
Zoll Medical (NSDQ:ZOLL) said it won 510(k) clearance from the for its ZOLL X monitor/defibrillator, a smaller, more powerful device aimed at the EMS market.