The Food and Drug Administration has been very active on the mobile health front this year and has cleared 23 mhealth apps as medical devices for the year to date from data aggregators and thermometers to remote monitoring devices to detect motion, posture and vitals, according to Mobihealthnews.
Cardiology has dominated , accounting for seven of these device approvals, followed by remote monitoring apps. Here are some highlights from the aggregated list.
Otoharmonics, a Portland, Oregon-based business, secured clearance for its sound therapy program to treat tinnitus. Its Levo Manager identifies and “maps each individual’s tinnitus sounds, creates personalized therapy, and tracks patient improvement over time,” according to its website.
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Qardio’s QardioArm uses a cuff that’s wrapped around the upper arm and reads the user’s systolic and diastolic blood pressure and heart rate. It wirelessly transmits the readings to an iOS device. The cuff has a companion app that aggregates and stores readings, so users can track their data and share it with their doctors.
It also has sends reminders and has a patent-pending function that displays calming images when a person is taking a reading, to prevent their blood pressure from rising due to the anxiety associated with the anticipation of finding out their latest reading.
Gauss Surgical secured de novo FDA clearance for its Triton Fluid Management System app to deal with the problem of overdoing it on blood transfusions during surgery. It uses an iPad camera to scan surgical gauze covered in blood. It uses an algorithm to provide the OR staff with an estimate of how much blood has been collected in the sponges. That information can be used to figure out if, or when, to start a blood transfusion.
AliveCor got clearance to extend its smartphone ECG indication to detect atrial fibrillation, a condition that’s a major risk factor for stroke.
A Personalized Approach to Medication Nonadherence
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
Global Kinetics Corp, an Australian company, won clearance for its wearable monitor Personal KinetiGraph earlier this month. The monitor is worn on the wrist like a watch and tracks a Parkinson’s disease patient’s movements to help neurologists track any changes in the patient’s movement and tweak their therapy accordingly.
