Follow on Google News News By Tag Industry News News By Location Country(s) Industry News
Follow on Google News | New babyLance Safety Heelstick Logo AnnouncedReflects U.S. FDA 510(k) Clearance for Marketing Neonatal Heelstick Device with a Sharps Prevention Indication
By: MediPurpose™ Along with a restyled baby's foot icon, the logo also features the brand's updated product description -- "safety heelstick" -- that reflects last month's U.S. FDA 510(k) clearance as a sharps prevention device. The logo was designed by R+M, a North Carolina branding agency. MediPurpose has been partnering with R+M for other branding projects, which include both babyLance and MediPlus(tm) A Prudent Approach to Marketing a Safety Device Indication MediPurpose had previously received a 510(k) in July 2010 for its original babyLance, reported to be the first infant heelstick device given FDA clearance for a sharps prevention indication. However, the company did not want to assume that the original 510(k) would still be valid for sharps safety indications for its new device. As a result, MediPurpose elected to launch the redesigned product as the "babyLance infant heelstick" without making the sharps safety claim. "There was somewhat of a gray area within the guidelines that dictated whether or not we could legally market the new babyLance as a 'safety heelstick' in the United States without submitting a new 510(k) application," MediPurpose today also announced a new white paper, “Reinventing a Better Safety Heelstick: Obtaining U.S. FDA 510(k) for Sharps Prevention Features,” about the company's decision and process for submitting a new safety heelstick 510(k) application. About babyLance Safety Heelsticks After investing more than a year in the redesign of its babyLance safety heelstick, MediPurpose launched its all-new neonatal heel incision device in August 2012. babyLance is available in two models, each with a specific blade penetration: * babyLance BLP (preemie): 0.85 mm depth * babyLance BLN (newborn): 1.0 mm depth Specifically designed to meet end-user expectations for the ideal heelstick, the new babyLance provides enhanced stability, comfort and ease of use. To download the white paper, please visit http://www.medipurpose.com/ For more information about babyLance safety heelsticks -- including no-cost product sample requests -- please visit http://www.medipurpose.com/ About MediPurpose Founded in 1999, MediPurpose is an innovative medical device company headquartered in Singapore, with offices in the United States and Europe. Known for its popular babyLance(tm) MediPurpose's Medical Device Innovation division offers angel funding and developmental expertise for new medical device inventors and innovative medical product companies that seek entrance into new medical device markets. For more information about MediPurpose's medical products and solutions for inventors, innovators, manufacturers and distributors, please visit http://www.medipurpose.com. End
Account Email Address Account Phone Number Disclaimer Report Abuse
|
|