Companies with new, often implantable devices that enable the remote monitoring of patients aim to enable a new, more efficient kind of disease management. However, one of the biggest hurdles to adoption of disease management to date has been lack of reimbursement. The patients that can most benefit from disease management--sufferers of congestive heart failure, for example--tend to be elderly people that are covered by Medicare, which has no mechanisms to reimburse for disease management. So, beyond the usual hurdles that device companies face, of working the kinks out of technology and proving its clinical value to physicians, patient monitoring companies also need to find the right delivery model that helps them get paid for their technology.
by Mary Stuart
In the medical device world, over the last decade or so, it's become somewhat axiomatic that small companies innovate, introducing...
Join thousands of industry professionals who rely on Medtech Insight for daily insights
Already a subscriber?
After multiple warning letters and safety communications, the US FDA has decided to block the import of certain endoscopes from Olympus. In total, the agency’s action pertains to 58 device models manufactured by the Japanese firm used in urinary, respiratory, abdominal and pelvic procedures.
Healthcare product industries await publication of the NHS 10-Year Plan, due out the coming days, which will focus on health generally not just the NHS, UK health secretary Wes Streeting said during a final prelaunch event on 24 June.
From June 30, new European Commission rules will attempt to redress an imbalance in medtech trade between the EU and the People’s Republic of China.
Legal experts warn, however, that new Mexican procurement rules are discriminatory and could be challenged in the courts.
Legal experts warn, however, that new Mexican procurement rules are discriminatory and could be challenged in the courts.
The US FDA has announced classifications for five device types, including four diagnostics as well as a hand cream to protect healthcare workers exposed to radiation. Two of the products are newborn screening tests.
It’s no secret that Marty Makary and Robert F. Kennedy Jr. have a different take on user fees, with Makary viewing them as a funding necessity and Kennedy as a corrupting influence. But will they find a way to strike a balance during the next MDUFA reauthorization talks so each can claim victory?
