Hundreds of biopharma leaders say Dr Richard Pazdur has the necessary qualities to lead the FDA amid a crisis of confidence.

Ideating on Glooko’s existing EndoTool system, the cloud-based version is designed to support more scalable deployment across hospital settings.

BlueWind plans to use the funds for expanding sales functions and market access initiatives for its Revi implantable tibial neuromodulation system.

Butterfly Medical has raised $21m in Series C funding for the development and potential commercialisation of its minimally invasive device for BPH.

Ardent Health and Fujifilm Healthcare are to bring Synapse enterprise imaging solutions to its acute care hospitals across six US states.

UroMems plans to use the funds to complete a pivotal trial to support regulatory filings for its UroActive system in the US and Europe.

AngioDynamics has reported two-year data from the PRESERVE pivotal trial, showing durable outcomes for the NanoKnife IRE system in treating intermediate-risk prostate cancer.

Revvity has received FDA clearance for its total testosterone automated ChLIA via its Immunodiagnostic Systems subsidiary.

J&J has globally launched its Shockwave C2 Aero coronary IVL catheter, which aims to help in the treatment of calcified CAD.

The US Food and Drug Administration (FDA) has cleared Bayesian Health’s continuous artificial intelligence (AI)-driven sepsis monitor, making the device the first of its kind to ...

The CoMira Diagnostics JV has completed a lease agreement for its planned manufacturing facility in Sudair Industrial City, Saudi Arabia.

The raise will support Rivermark’s pivotal trial on its FloStent device, which is in development to treat patients with an enlarged prostate.