Makers of wireless health devices bemoan slow FDA approval process

Computerworld - SAN DIEGO -- Makers of wireless electronic health devices bemoaned the federal product approval process and stingy insurance reimbursements for life-saving technology that they argued could reduce overall national health-care costs.

Despite a federal priority on health care reform, the U.S. Food and Drug Administration is not doing all it should to boost approval of wireless e-health devices for monitoring patients, said Eric Collins, CEO of Montage Systems, during a panel discussion at the International CTIA Wireless I.T. and Entertainment conference.

"With the FDA recently saying too many [medical] devices are getting approved too easily and some other things they are articulating, it's frustrating," Collins said. His company has developed a prototype device called the Wireless Healthphone for sending patient data wirelessly to doctors and other caregivers.

The wireless e-health industry "has a huge opportunity to improve the health care system and reduce costs, but Washington is clearly not paying attention to technology at this level, " Collins added during Thursday's panel presentation.

Collins spoke on a panel with representatives of four companies deploying wireless technology for remote health care. The panel also included Qualcomm Inc., which has work underway with 30 smaller companies deploying software and hardware that will depend on radio communications to provide continual feedback on body systems or to monitor diseases such as diabetes and a variety of cardiac ailments.

Aaron Goldmuntz, director of business development for CardioNet, said his company began offering wireless cardio monitoring technology nearly a decade ago and described FDA approvals of the technology as having generally gone smoothly. However, his company recently faced a reduction in insurance reimbursements for which CardioNet patients are eligible.

Lower insurance reimbursements are also problem for providers of telemedicine applications, said Charlie Huiner, vice president of business development for InTouch. "Broadly speaking, telemedicine is not broadly reimbursable," Huiner said. "You are not necessarily able to charge and get reimbursed."

Huiner said his company has installed 250 robot-like devices in medical centers that allow hospital patients lying in a bed to talk remotely over a live video connection to a doctor, giving them the ability to speak to a personal physician instead of a hospital attending physician whom they have never met. But insurance won't cover the cost of a robot consultation unless the patient is in a rural or narrowly defined area, Huiner said.

Collins said he is trying to get FDA approval for the Healthphone, a handheld device about the size of a pager that gathers data wirelessly from a patient's body and forwards it over a network to a computer monitored by doctors or other caregivers.