New babyLance Safety Heelstick Logo Announced
Reflects U.S. FDA 510(k) Clearance for Marketing Neonatal Heelstick Device with a Sharps Prevention Indication
Atlanta, GA, April 06, 2013 --(PR.com)-- MediPurpose(tm), a manufacturer and master distributor of medical products, today announced a new logo for its babyLance(tm) safety heelstick.
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) Advanced Wound Care products.
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," said MediPurpose founder and CEO Patrick Yi, who also lead the babyLance redesign team. "Although applying for another 510(k) involved considerable time and cost, we wanted to submit our innovative new infant heel incision device so that we and our customers could be confident that it meets FDA guidelines for a safety device with sharps prevention indications."
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/downloads.
For more information about babyLance safety heelsticks -- including no-cost product sample requests -- please visit www.medipurpose.com/babylance.
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) safety heelstick, SurgiLance(tm) safety lancet and MediPlus(tm) advanced wound care products, MediPurpose has leveraged its success in the medical device industry to become a master medical product distributor that provides unique solutions for both medical product manufacturers and distributors.
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.
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) Advanced Wound Care products.
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," said MediPurpose founder and CEO Patrick Yi, who also lead the babyLance redesign team. "Although applying for another 510(k) involved considerable time and cost, we wanted to submit our innovative new infant heel incision device so that we and our customers could be confident that it meets FDA guidelines for a safety device with sharps prevention indications."
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/downloads.
For more information about babyLance safety heelsticks -- including no-cost product sample requests -- please visit www.medipurpose.com/babylance.
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) safety heelstick, SurgiLance(tm) safety lancet and MediPlus(tm) advanced wound care products, MediPurpose has leveraged its success in the medical device industry to become a master medical product distributor that provides unique solutions for both medical product manufacturers and distributors.
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.
Contact
MediPurpose
Derek Rudnak
888-808-6494
www.medipurpose.com
Derek Rudnak
888-808-6494
www.medipurpose.com
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