FDA clears PhysIQ’s Personalized Physiology Analytics Engine Software
It is the first FDA-cleared product to receive the code PLB: Automated calculation of a summary index based on several individual measured vital sign inputs.
FDA greenlights Sentrian’s Remote Patient Intelligence solution
Sentrian's RPI is not subject to further FDA regulatory requirements at this time, and the company can immediately begin marketing its solution in the U.S.
FDA clears Propeller’s platform in association with Boehringer Ingelheim’s an GSK’s inhalers
FDA-approved marketing claims of improved adherence and reduction in exacerbations address key unmet needs in respiratory health.
St. Jude Medical Invisible Trial System receives an FDA approval
The wireless system is designed to help chronic pain patients better assess spinal cord stimulation therapy prior to permanent implant.
FDA to use Google search data to find adverse drug reactions
The deal with Google would allow the agency to look into another set of data, one that doesn't come from specific subsets of the population.
FDA says Proteus Ingestible Sensor can be used for medication adherence
When used with a medication, the Ingestible Sensor marks actual intake time, which is a quantifiable event that has allowed FDA to grant the expanded indication.
Smart pelvic floor muscle training device for incontinence cleared by the FCC
Called PeriCoach, the device is designed to reduce or stop urinary incontinence, and will commercially launch in the US later this week.
FDA, PatientsLikeMe team-up to increase patient experience of drugs in post market reviews
The FDA will get access to PatientsLikeMe's 110,000 adverse event reports on 1,000 different medications will be used as a supplement to traditional sources.
Cohero Health’s smart spirometer clears the FDA
The Bluetooth-enabled, smartphone-connected device measures critical lung function with comparable accuracy to clinical-grade spirometers.
Wearable for posture and movement tracking gets another FDA clearance
Called ViMove, the device features a number of sensors that enable tracking of static postures like a natural standing posture and various sitting postures.