Design Change, Validation Found Lacking at InterX Technologies September 22, 2016 The FDA investigator found there was a change in the liners in the gel electrodes. Read More
Thermo Fisher Wraps Up $4.2 Billion Buyout of FEI September 21, 2016 FEI designs, manufactures and supports high-performance electron microscopy workflows. Read More
Medtronic Drug-Coated Balloon Approved for In-Stent Restenosis September 21, 2016 The expanded indication for the device marks the first approval in the U.S. for a drug-coated balloon. Read More
Adamas Present Results of Pivotal Trial of ADS-5102 for the Treatment of Levodopa-induced Dyskinesia in Parkinson’s Disease Patients September 21, 2016 The trial met its primary endpoint. Read More
Australia’s TGA Releases Guidance on Registering Class IV In Vitro Diagnostics September 21, 2016 Sponsors need to first submit manufacturer evidence, and the TGA needs to approve it, before applications can be submitted. Read More
Industry Doubtful of Reference Databases in FDA Draft Guidance for NGS-Based Diagnostics September 21, 2016 Microbiologics said in its comments that the reference databases are not at a sufficient capacity to meet current diagnostics needs. Read More
FDA Grants 510(k) Clearance to GI View’s Aer-O-Scope Disposable Colonoscope System with Therapeutic Access September 20, 2016 More than 690,000 people worldwide die from colorectal cancer annually. Read More
Claret Medical Submits Marketing Application to FDA for Combination Device September 20, 2016 A device is designed to protect the brain by capturing and removing debris dislodged during TAVR. Read More
NICE Vouches for IUD as Emergency Contraception September 20, 2016 The IUD can be used as an emergency method of contraception within five days. Read More
Combination Products Added to FDA’s 2016 Guidance Lineup September 20, 2016 The guidance follows increased concern over the FDA’s review of generics for Mylan’s EpiPen. Read More
FDA Releases Final Guidance on COPD Biomarker September 19, 2016 The biomarker can be used by drug developers in submissions of INDs, NDAs, and BLAs. Read More
ViewRay Obtains CE Mark for its MRIdian Linac System September 19, 2016 The company has also submitted its 510(k) application for the device in the U.S. Read More