FDA approves first autoinjector for Betaseron
The FDA has approved Bayer's (Whippany, N.J.) Betaconnect electronic autoinjector for the treatment of relapsing-remitting multiple sclerosis (RRMS). It is the first and only electronic autoinjector for RRMS treatment.
The device offers customizable injection speed and depth settings that allow patients to inject quietly with precision at the touch of a button. Betaconnect has an optional backup reminder function that lets users know when it is time for their next injection. In addition, the automatic needle insertion and retraction has an audio and visual end-of-dose indication that lets patients know when the injection is complete.
Betaconnect will be available in early 2016 to patients who are receiving interferon beta-1b (Betaseron).
Recall issued for OmniPod Insulin Management System
A recall has been issued for the Insulet Corporation's OmniPod Insulin Management System because the company identified the following two issues with the devices:
* The cannula either fails to fully insert into the skin or completely retracts after insertion. The failure occurs without an alarm, and the pod continues to pump insulin.
* The pod provides an audible alarm signal and displays a failure but will not pump insulin once the alarm occurs.
The FDA warns that both failures can result in an inaccurate dosage of insulin, which can lead to hyperglycemia and trigger life-threatening conditions or death if untreated. Insulet received 9 reports in which the device malfunctioned, including 5 injuries and no reports of death as of September 10, 2015.
New laser-based hearing aid approved
The FDA approved the marketing of the EarLens Contact Hearing Device (CHD), a new hearing aid that uses a laser diode and direct vibration of the eardrum to amplify sound. The EarLens CHD is indicated for adults with mild-to-severe sensorineural hearing impairment.
The EarLens uses a combination of laser light pulses and a custom-fit device component that comes in direct contact with the eardrum and is designed to use the patient's own eardrum as a speaker. This enables amplification over a wider range of frequencies for some hearing-impaired patients.
The EarLens CHD consists of two parts: a tympanic membrane transducer (TMT) that is nonsurgically placed deeply in the ear canal on the eardrum and a behind-the-ear (BTE) audio processor that sits on the outer ear and is connected to an ear tip that is placed in the ear canal. External sound waves received by the BTE processor are converted to electronic signals, digitally processed, amplified, and sent to the ear tip, which contains a laser diode. There, the electronic signals of amplified sound are converted to pulses of light, which shine onto a photodetector in the TMT, which then converts the light back into electronic signals, transmitting sound vibrations directly to the eardrum by direct contact.
The EarLens CHD is a product of the EarLens Corporation of Menlo Park, Calif. An early 2016 launch is expected.
FDA approves t:slim G4 Insulin Pump with CGM Integration
Tandem Diabetes Care, Inc. (San Diego, Calif.) announced FDA approval of the t:slim G4 Insulin Pump, the first and only touch-screen insulin pump with continuous glucose monitoring (CGM) integration for use by patients 12 years of age or older who use insulin. The t:slim G4 combines features of the t:slim Insulin Pump and Dexcom G4 Platinum CGM System into a single device with a slim design that is easy to use.
According to Tandem, the t:slim G4 is the only insulin pump that conveniently displays CGM graphs and trend information with current insulin delivery activity together on the home screen to help make informed treatment decisions.