FDA Clears New No-Code Blood Glucose System
Arkray USA (Minneapolis, Minn.) has received FDA clearance for the Glucocard 01 Blood Glucose Monitoring System, which requires no coding, displays results in 7 seconds, and needs only a 0.3-mcL sample size of blood. The Glucocard 01 is AST approved and has a 360-count test memory with time and date stamp. It also features a large, easy-to-read display for better viewing of test results.
According to Arkray, clinical data show Glucocard 01 to be accurate. The product is also sleek, compact, and discreet.
New Glucose Management System Allows Remote Insulin Dosing
Animas Corporation (West Chester, Pa.) received approval for the marketing of the company's OneTouch Ping Glucose Management System. The OneTouch Ping is the first full-feature insulin pump that wirelessly communicates with a blood glucose meter-remote. Using the OneTouch Ping meter-remote, a person can calculate insulin dosage and opt to wirelessly instruct the pump to deliver the dose without touching the pump at all. They no longer have to access the pump to deliver a bolus.
The pump can be clipped to a belt, tucked in a pocket, or secured under clothing. It is waterproof up to 12 feet for 24 hours and has a color screen for clear readability. The pump also features individualized control, delivering basal increments of 0.025 units/hour and bolus increments of 0.05 units to more precisely match patient insulin needs.
The meter-remote uses OneTouch Ultra Test strips. The system also works with the recently cleared ezManager MAX Diabetes Management Software.
Device Helps Spinal Patients Breathe Without Ventilator
The NeuRx DPS RA/4 Respiratory Stimulation System from Synapse Biomedical (Cleveland, Ohio) has received FDA approval. The implantable electronic device stimulates the diaphragm, helping certain patients with spinal cord injuries to breathe for at least 4 hours without a mechanical ventilator.
The FDA approved the distribution of the device under a Humanitarian Device Exemption because it is likely to treat or diagnose conditions that affect fewer than 4,000 people per year.
A multicenter trial showed the device to be safe and have probable benefit to the patient by allowing at least 4 hours per day of freedom from a mechanical ventilator.
Honey-Containing Wound Care Product Now Available OTC
Derma Sciences (Princeton, N.J.) has received FDA approval to sell its wound care product, MEDIHONEY Wound & Burn Dressings with Active Leptospermum Honey, without a prescription. This gives consumers access to the product for wounds and burns that do not require the attention of medical professionals.
Four versions of MEDIHONEY have been approved by the FDA for sale; all four were cleared for over-the-counter sales. Consumers can now buy these sterilized, standardized, and regulated all-natural products for their first aid kits. All versions of MEDIHONEY have been tested through rigorous randomized controlled studies, according to Derma Sciences, and shown to be safe and effective.