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.
"We believe the X Series is a game changer for Zoll in the EMS market. We have the size and weight advantages that Zoll is known for without compromising features or functionality," president Jonathan Rennert said in prepared remarks. "The X Series has every advanced monitoring and communication capability required by EMS providers and, ultimately, critical care transport operations."
The device incorporates the rainbow SET patient monitoring technology made by Masimo (NSDQ:MASI), according to a press release, as well as a non-invasive blood pressure measurement module made by Welch Allyn.
ZOLL shares were trading at $92.75 as of about 11:45 today, up 0.02% on the day.
Hill-Rom says FDA warned it on production, promotion
Hill-Rom Holdings (NYSE:HRC) said it received a warning from the FDA March 6 after an agency inspection turned up "certain observed instances of non-compliance with FDA regulations," according to a regulatory filing.
Hill-Rom said it had already corrected "a number of the observations" the FDA noted after its inspection of the Batesville, Ind., facility named in the warning letter, which has yet to be posted to the FDA’s website.
"The warning letter does not restrict Hill-Rom’s ability to manufacture or seek 510(K) clearance of products, nor does it require the withdrawal of any product from the marketplace," according to the filing. "The company believes that these matters will not have a material impact on the company’s financial results. However, the company cannot give any assurances that the FDA will be satisfied with its response to the warning letter or as to the expected date of the resolution of the matters included in the warning letter." Read more