Medical Microinstruments captured €20 million ($24.5 million) in series A financing it will use to develop a robotic system for microsurgery.

Novocure wants to bring the electric field device to market in mesothelioma via the rarely used humanitarian device exemption.

FDA officials developed the strategy to address the emerging cybersecurity threat and to incentivize device designers to focus on safety innovations.

The partners will use Illumina’s NGS capabilities to create IVDs that assess tumor mutation burden and other potentially predictive biomarkers.

The cash sets Intact up to advance a clinical development program designed to generate data to support FDA approval of the Tack Endovascular System.

The investment sets the Kite Pharma-partnered firm up to refine software to orchestrate the many steps involved in the production of cell therapies.

Boston Scientific will pay up to $275 million to acquire nVision Medical, the developer of a device used for early detection of ovarian cancer.

The embattled executive wants investors to save Theranos from the prospect of running dangerously low on cash by the end of July.

The FDA issued final guidance on developing and validating next-generation gene sequencing tests and a third draft guidance on in vitro diagnostics.

The FDA plans to allow firms to use abbreviated 510(k) conformity mechanisms to demonstrate all performance characteristics.