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babyLance Infant Heelstick Registered with Italian Competent Authority
Equivalent of U.S. FDA Registration, CA Registration Enables Distribution of babyLance in Italy
Registering babyLance with the Ministero della Sanita (Ministry of Health) enables Italian medical product distributors to market the infant heel stick to hospitals and healthcare providers in Italy.
babyLance is a single-use heel incision device utilized to obtain a blood sample from the heel of newborn (babyLance BLN) and preemie (babyLance BLP) infants.
Launched in the United States last year, babyLance was the first infant heel stick to receive U.S. Food & Drug Administration 510(k) clearance with sharps prevention indications. Four integrated components were crucial for its U.S. FDA 510(k) with sharps prevention indications clearance:
* A locking mechanism to prevent accidental activation of the device.
* A housing that conceals the blade before and after the device is used.
* An internal spring that automatically retracts the blade after use.
* A stop feature that disables the device after a single use.
To receive the U.S. FDA 510(k) clearance for babyLance, MediPurpose was required to submit results from a simulated use clinical study of 500 samples.
Conducted in March 2010 at the Nanyang Polytechnic School of Health Sciences in Singapore, the simulated clinical use study mimicked actual clinical use by using a foam foot as a patient substitute. Twenty registered nurses tested the safety and function of a total of 500 babyLance heel sticks.
The study yielded a 100-percent success rate for the babyLance’s safety features and function, with not a single test participant encountering any problems with or malfunctions of the devices.
The study concluded that babyLance functioned safely with a single-handed technique, and evaluators commented that the device was relatively easy to use.
More information about babyLance--including demonstration videos and no-cost product sample requests--is available at http://www.medipurpose.com/
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Founded in 1999, MediPurpose is a leading medical device company headquartered in Singapore, with offices in the United States and Europe.
Known for its popular babyLance heel incision device, SurgiLance safety lancet and MediPlus 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 medical product distributors.
MediPurpose's 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’