In Brief: Nellcor
This article was originally published in The Gray Sheet
Nellcor: Expects U.S. shipments to begin immediately for the first two modules of its Symphony monitoring system -- the N-3000 pulse oximeter and the N-3100 non-invasive blood pressure monitor. The market release of both products follows FDA clearance last week of a 510(k) for the N-3000. The N-3100 was cleared in March. Sales of the Symphony system, introduced internationally in 1994, will focus on noncritical hospital and alternate site markets...
You may also be interested in...
Previous businesses FDA warned about COVID-19 claims for chlorine dioxide, a bleach solution, were marketing dietary supplements unlawfully. But Pro Breath MD's oral rinses available under the Dentist Select and OraCare brands are allowed and FDA isn’t asking the firm to discontinue distribution.
The Stark Law ban on self-referrals wouldn’t apply to some physician owners of advanced imaging facilities under a CMS final rule.
Pfizer’s abrocitinib and Biogen/Eisai’s aducanumab are among a host of new investigational products that are under review by the European Medicines Agency.