GOP lawmakers want to know if FDA plans to tax medical software apps. A company creates a prosthetic skull implant with 3-D printing. Sensors, the next step in digital health, may already be displacing devices.
House Republicans Question FDA on Taxing Medical Apps
A House committee will be holding three days of hearings next week to question FDA in regards to regulation of medical mobile apps. If a medical app is created for a smartphone, is that phone now considered a medical device? Is the company that developed the software subject to the device tax? Questions like these are becoming a growing concern among companies and lawmakers, who believe taxing software will further slow market growth. [Bloomberg Businessweek
However, all things considered, asking whether or not FDA guidance includes taxation of medical apps could be a dumb question.
Man Receives 3-D-Printed Skull Prosthetic
An unnamed man in the United States has had 75% of his skull replaced by a 3-D printed implant. The implant, called the OsteoFab Patient Specific Cranial Device, was cleared by FDA in February and is made of PEKK. Oxford Performance Materials, the company behind the implant is also currently developing 3-D-printed bone implants for other parts of the body [Popular Science
Are Sensors Killing Devices?
contributor John Nosta believes the next wave of digital health is already here in the form of sensors that will quickly displace devices on the market. [Forbes