Endostream Medical, the developer of an implant device for the treatment of brain aneurysms, will operate as Kaneka’s first Israeli R&D hub The post Japan’s Kaneka buys Israeli medical device startup ...

International reliance is a mechanism whereby certain medical devices ... submission process, but may be assessed during the review of post-market events if needed. Evidence of approval and ...

The Paradise uRDN system is currently commercially available for patients in the US having received FDA approval in November 2023. It is indicated to reduce blood pressure as an adjunctive treatment ...

Koh Young Technology gains FDA approval for medical robot in brain surgery Koh Young Technology secures FDA clearance for innovative robotic system in neurosurgery ...

SIGA Technologies (NASDAQ:SIGA) announced Thursday that Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) approved its antiviral product Tepoxx (tecovirimat) for the treatment of ...

TEPOXX is the first antiviral therapy approved by the Pharmaceuticals and Medical Devices Agency (PMDA), in collaboration with the Japan Ministry of Health, Labour and Welfare, for the treatment ...

Tepoxx is the first antiviral therapy approved by the Pharmaceuticals and Medical Devices Agency (PMDA), in collaboration with the Japan Ministry of Health, Labour and Welfare, for the treatment of ...

Regulatory ApprovalFormycon and Fresenius Kabi announce MHRA approval for FYB202/Otulfi® (ustekinumab), a biosimilar to Stelara® 15.01.2025 / 06:30 CET/CESTThe issuer is solely responsible for the ...

TEPOXX is the first antiviral therapy approved by the Pharmaceuticals and Medical Devices Agency (PMDA), in collaboration with the Japan Ministry of Health, Labour and Welfare, for the treatment of ...

Our test devices will be easy-to-use ... Documentation is key, as clear, detailed records of your build process are essential for regulatory approval and compliance. Regulatory missteps are costly as ...