Olympus Medical Systems has agreed to pay $85m to the US Department of Justice (DOJ) to resolve charges over failing to file required adverse event reports related to duodenoscopes.
12 Dec 2018
28 Nov 2018
The US Food and Drug Administration (FDA) is planning to overhaul the framework for evaluating the safety and effectiveness of medical devices, the 510(k) clearance pathway, which was passed as a law forty-two years ago by the Congress.
22 Oct 2018
Ocular Therapeutix has received a warning letter from the US Food and Drug Administration (FDA) related to ReSure hydrogel ophthalmic wound sealant.
11 Oct 2018
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).
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.