The U.S. FDA’s surveillance of duodenoscopes and other endoscopes was initially driven by concerns about device sterility, but recent inspections of manufacturing sites operated by Olympus Medical Systems Corp., in Japan have fed warning letters for lapses from various regulations. In the latest warning letter, the agency cited one of the company’s sites in Tokyo for both quality system and medical device reporting lapses, the second warning letter issued to the company in roughly three months. Read More
Device makers doing business in the EU finally have official word that the new implementation dates for the Medical Device Regulation (MDR) are in force, offering some vital breathing room for products already on the market. However, manufacturers that wish to obtain a new certificate for their legacy devices still have a lot of work to do as they must file at least a preliminary application for these devices with a notified body (NB) by May 26, 2024, not a mean feat given the crunch on notified bodies operating in the EU. Read More
Spectrawave Inc. said U.S. FDA clearance of its flagship intravascular Hypervue imaging system will help physicians optimize coronary stenting in the cardiac catheterization lab. Read More
At the European Congress of Radiology 2023 in Vienna, a session was devoted to photon-counting CT (PCCT). A team of five clinical researchers from Germany, Ireland, Norway, the Czech Republic and Slovakia spent an hour presenting an update on the latest clinical progress for this new medical imaging technology. Read More
By adapting computational methods for dealing with large volumes of data, and slimming down that data, researchers at the Icahn School of Medicine at Mount Sinai have discovered previously unknown genetic associations with 19 rare diseases, and validated three of those associations. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Brain Scientific, Detection Technology, Genetworx, Imac Holdings, Oxford Nanopore, Northern Light, Quest Diagnostics. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Affamed, Asensus Surgical, Cue Health, Lunit, Surgvision. Read More
