TearLab's Discovery MMP-9 Test has failed to meet criteria for substantial equivalence based upon data and information submitted by the company in its 510(k) submission the US Food and Drug Administration (FDA).
11 Oct 2018
05 Oct 2018
MedISAO, a provider of cybersecurity information, education and tools for the medical device industry, has signed a memorandum of understanding (MOU) with the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) and the National Health Information Sharing & Analysis Center (NH-ISAC).
04 Oct 2018
The Transparency Committee of the French Haute Autorité de Santé (HAS) has given positive recommendation to Blue Earth Diagnostics' Axumin (fluciclovine (18F)) for use in PET imaging of suspected recurrent prostate cancer.
03 Oct 2018
ivWatch has received two patents granted by the European and Japanese Patent Offices expanding their intellectual property (IP) portfolio.
07 Sep 2018
Intuitive Surgical has submitted a premarket notification to the US Food and Drug Administration (FDA) for its robotic-assisted, catheter-based platform, designed to navigate through small lung airways to reach peripheral nodules for biopsies.
03 Sep 2018
ResMed, a tech-driven medical device firm, has lodged a patent infringement petition against New Zealand-based medical device manufacturer Fisher & Paykel Healthcare.
06 Aug 2018
Lubrizol’s Particle Sciences has received patent for a medication delivery device to the tympanic membrane.
30 Jul 2018
The US District Court for the District of Delaware has found that Minerva Surgical infringed two Hologic patents associated to endometrial ablation technology.
23 Jul 2018
Bayer has informed the US Food and Drug Administration (FDA) that it will stop the sale and distribution of its permanent birth control device Essure, after reports of injuries in women.
20 Jul 2018
Medical device distributor AngioDynamics has agreed to pay $11.5m to Federal governments and various states to settle the whistleblower case against it for selling Gelsphere device for unapproved chemotherapy eluting purposes.