Pressure Point Inc., a medical device developer focused on non-pharmacological products to alleviate the effects of nausea and vomiting, has achieved 510(k) premarket notification clearance from the US Food and Drug Administration(FDA) for its Pressure Right® single-use, disposable device designed to decrease the incidence of post-operative nausea and vomiting (PONV).
According to a company press release, applied to patients’ wrists before induction of anaesthesia, Pressure Right utilises a cost-effective pressure technology to complement the use of routine antiemetic drugs to mitigate negative effects of nausea and vomiting commonly associated with surgery and anaesthesia.
In USA, Pressure Right is a prescription-based, alternative medicine, non-invasive device using a pressure-sensitive adhesive delivery system featuring a pressure dome applied on the P6 acupuncture point with the intended purpose to interrupt the signal that triggers nausea and vomiting.
Through the use of its innovative delivery system, Pressure Right® has proven continuous quality of pressure applied to the P6 acupuncture point (without needles) from 0-72 hours in clinical settings.
Joseph DiLustro, chairman and CEO of Pressure Point, explains that his firm’s FDA 510(k) effort took several months. In order to address technology and performance issues raised by the FDA, the firm sought third-party support from medical device regulatory consulting firm Emergo Group, adds DiLustro.
“We chose professional representation because it was in our best interest to do so, considering that the 510(k) process is very complex,” DiLustro says. “Pressure Right® had to prove substantial equivalence to predicate devices based on strong clinical support, and because Pressure Right® uses different design features, we were required to perform very stringent performance testing for our indication for use. We needed a strong regulatory organization to advise us from conception through the 510(k) submission process.”
The company makes no mention of any plans for a European launch of its product.
Source: Pressure Point Inc