First marketing approval in China for Cinclus Pharma
Swedish clinical-stage drug developer Cinclus Pharma (STO: CINPHA), a specialist in treatments for gastric acid-related diseases, had picked up Chinese approval for linaprazan glurate. The outcome represents the firm’s first marketing approval in China. The approval by the National Medical Products Administration (NMPA) paves the way for commercialization in the People’s Republic of China in 2025. Read Article Here
SymPhysis Medical secures €2.2m funding for cancer patient device
Galway MedTech company SymPhysis Medical has secured €2.2m funding for the development of a device to address the condition of fluid in the chest of cancer patients. The medtech company will seek regulatory approval in the US for its device treating end-of-life cancer patients at the end of 2025. Business Post Article
Biggest impact on oral health since introduction of fluoride predicted as Sigrid Therapeutics announces market readiness of SiPore® Professional Care and Consumer Range Products
Sigrid Therapeutics today announced the market readiness of SiPore® for both the professional and consumer oral health markets. Read Press Release here
Signum Surgical’s BioHealx technology obtains FDA clearance
Signum Surgical, a medical technology company developing innovative solutions to treat colorectal diseases, is pleased to announce that its BioHealxTM technology has been granted marketing clearance by the U.S. Food and Drug Administration (FDA), as a first-of-its-kind medical device for the treatment of anal fistula. Read Press Release here
Irish medtech firm Deciphex has signed a collaboration agreement with Novartis.
Irish medtech firm Deciphex has signed a collaboration agreement with Novartis, the pharma giant, to develop artificial intelligence solutions to aid drug discovery and development. Read Full Article
CroíValve wins FDA IDE for tricuspid heart valve
CroíValve announced today that it began an early feasibility study for its Duo tricuspid coaptation valve system. The beginning of the study follows FDA investigational device (IDE) approval. Read Full Article
Galway-based medtech FeelTect to expand following €1.5m funding raise
The Spiddal company is to recruit six staff across research and development, manufacturing, project management, clinical affairs, and commercial strategy. The majority of the new roles will be based in Ireland, with commercial and clinical roles spread across the United States and Europe to support international growth. Read Full Article
Aruna Bio Announces FDA Clearance of IND for Lead Program AB126
Aruna Bio Announces FDA Clearance of IND for Lead Program AB126, Enabling the First Exosome to Enter in Human Clinical Trials for a Neurological Indication Read Full Article