After discussions with the U.S. Food and Drug Administration, EnteroMedics will apply for approval to conduct another human trial to supplement results from an earlier study, which showed the company's Maestro's device did not perform any better than the control group.
Last November, Nasdaq threatened to delist EnteroMedics because its stock failed to trade above $1.00 for ten consecutive days. The company has until May 12, 2010 to comply with the rule or face expulsion- again.
As technology advances, AI-powered tools will increasingly reduce the administrative burdens on healthcare providers.
EnteroMedics is dangling precariously off a cliff. Last fall, initial results from its Empower clinical study failed to meet the company's goals.
The medical device industry, long the backbone of Minnesota's high tech economy, faces perhaps its most challenging environment in decades. From regulatory headaches and health care reform to a dearth of venture capital, medical device stakeholders face a swirling mix of uncertainty and anxiety.