FDA News Briefs for Monday, June 10, 2019June 10, 2019
These Food and Drug Administration (FDA) developments came in last week:
FDA Clears Device to Treat IBS Pain in Adolescents
The FDA granted a de novo clearance for IB-Stim (Innovative Health Solutions Inc.), a neurostimulator device indicated to aid in the reduction of functional abdominal pain in patients 11-18 years of age with irritable bowel syndrome (IBS) when combined with other therapies for IBS. IBS is a condition affecting the large intestines that can cause abdominal pain and discomfort typically related to bowel movements. The IB-Stim is a prescription-only device comprised of a small single-use electrical nerve stimulator that is placed behind the patient’s ear. It contains a battery-powered chip that emits low-frequency electrical pulses to stimulate branches of certain cranial nerves continuously for 5 days, at which time it is replaced. Stimulating nerve bundles in and around the ear is thought to provide pain relief. Patients can use the device for up to 3 consecutive weeks to reduce functional abdominal pain associated with IBS. More Information.
Expanded Approval for Emflaza
The FDA has granted an expanded approval for Emflaza (deflazacort; PTC Therapeutics) for the treatment of Duchenne muscular dystrophy (DMD) in patients 2 years of age and older. Emflaza was previously approved for the treatment of Duchenne muscular dystrophy (DMD) in patients 5 years of age and older. More Information.
Recall: Hamilton-G5 Ventilators
Hamilton Medical AG is updating all Hamilton-G5 Ventilators with a newly developed software version to reduce the probability of the user message “panel connection lost” and the ventilator entering an ambient state. The user error message is due to a blocked or terminated communication between the ventilation unit processor and the interaction panel processor. While there have been complaints due to this user message error, no patient injury or harm were reported. More Information.