With health care becoming increasingly data driven, third-party payors are requiring a higher level of evidence before making a positive coverage determination for a new technology or procedure. This has made the road to reimbursement much longer and tougher for device companies in general, and manufacturers of transoral devices for GERD are a prime example.

At the recent 12th World Congress of Endoscopic Surgery, hosted by the Society of American Gastrointestinal and Endoscopic Surgeons, physicians discussed the challenges of identifying patients at risk of esophageal cancer. Barrett’s esophagus has long been known as a risk factor, but it remains a mystery as to how to predict which patients with Barrett’s will progress to esophageal cancer and who to screen in order to prevent it,

Novasys Medical is using radio frequency (RF) energy to treat stress urinary incontinence in women. The company chose to adopt a much more rigorous and expensive clinical trials strategy than was needed to gain FDA approval of its device. This approach flummoxed the FDA,, slowing approval of the company's IRenessaI system. Novasys is betting that the enhanced data collected from its clinical study will result in the company gaining faster reimbursement that it hopes will drive adoption.

EndoGastric Solutions has found a new approach to GERD surgery: trans-orally with an endoluminal approach. The new procedure should go minimally-invasive surgery one better, but in the process opens up a huge debate: will endoluminal GERD surgery be the province of gastric surgeons or gastroenterologists?