Asthmapolis obtains clearance for new sensor and app software
The FDA granted Asthmapolis 510(k) clearance for a new sensor that sits atop an inhaler, records every use of the inhaler and transmits the information to an app on the user’s mobile device(s). The software that runs the app received FDA approval as well.
Keeping track of usage patterns, including frequency of use and length of use, will help both asthma patients and their doctors better manage the condition.
Links Medical lands both FDA and EU wins for honey-based wound dressing
Irvine, Calif.-based company Links Medical obtained FDA clearance as well as CE Mark approval in the European Union for a wound dressing product made of honey. Manuka IG, the new product, is a non-tacky, contact layer dressing that will address sterilization concerns in advanced wound and burn care management.
VisionCare receives Medicare reimbursement code for implant procedure
VisionCare Ophthalmic Technologies received a reimbursement code from the AMA for a procedure that requires the implantion of the company’s Miniature Telescope device. The code will be effective July 1, 2012 for Medicare patients.