Experienced Software/Firmware engineer with PCB design experience. This individual should be local to Orange County CA and have some medical device experience. This is someone we are looking to add… Continue Reading »
The U.S. Food and Drug Administration announced last week it is investigating a number of medical device reports of infections and potential contamination issues with reprocessing urological endoscopes.
Hennigsdorf/Berlin, Germany, March 23, 2021 – Diagnostics company SphingoTec GmbH (“SphingoTec”) announced today the first published data (1) on the biomarker DPP3 that can predict the evolution of organ function and survival in septic patients.
QuantuMDx, a UK-based life sciences company developing point-of-care molecular diagnostics, has raised £11 million in its latest funding round.
BioIntelliSense partners with Leukemia & Lymphoma Society to incorporate the BioSticker platform in clinical trials of hematological cancer…
With concerns rising, the FDA has hired Kevin Fu, PhD, as the first acting director of medical device cybersecurity, a new 1-year position within the Center for Devices and Radiological Health.
Leading NMR diagnostics company numares AG today announced that the company made a 510(k) submission to the U.S.Food and Drug Administration (FDA) fo…
Funding will be used to gain in-human data for startup’s OxiFlow brain haemorrhage solution.
Fusion Robotics LLC, a spinal robotics and navigation company today announced receiving 510(k) clearance to market their 3D imaging compatible navigation and robotic targeting system for spine surgery in the U.S.
The preceding articles of this series laid out how the new EU Medical Device Regulation 2017/745 (“MDR”) leads to a broader coverage of medical devices and an overall deeper level of…
Cognition Corporation, a SaaS solutions provider for guided compliance in medical device and pharmaceutical product development, has released a new suite of risk management functionality in its Compass solution.