Medical technology company Implantica AG (Nasdaq First North Premier Growth Market: IMP A SDB) announced on Thursday that the US Food and Drug Administration (FDA) has granted Premarket Approval (PMA) for RefluxStop, the company's implant-based treatment for gastroesophageal reflux disease (GERD).
This approval allows Implantica to begin commercial launch activities in the United States, the world's largest medical device market.
FDA approval follows the regulator's full review of the RefluxStop PMA application, including long-term clinical evidence supporting the five-year safety and effectiveness of the therapy.
RefluxStop is designed to address the underlying cause of acid reflux by restoring and maintaining the natural anatomy of the gastroesophageal junction, without encircling or applying pressure on the food passageway.
Amsino receives Vizient contract for enteral syringes
Sisram Medical introduces Titanium Prime treatment concept in Hong Kong SAR
Proteotype unveils Alchemi platform for blood-based multi-cancer test Enlighten
Insulet expands European footprint with Omnipod 5 and Omnipod Discover launch in Spain
Frontier IP portfolio company InSignals wins EU grant and launches Parkinson's app
PharmaResearch to acquire CG USA to support North American expansion of REJURAN Cosmetics
United Therapeutics wins FDA approval for LungFX ex vivo lung perfusion device
Natera Signatera gains PMDA approval in Japan for colorectal cancer testing
Getinge launches Fluobeam LS for fluorescence‑guided small‑incision surgery
Airiver Medical treats first chronic rhinosinusitis patient in Drug Coated Balloon clinical study
Galmed Pharmaceuticals to acquire Colospan for GI-focused platform development