The Lung Cancer Genomic Screening Project for Individualized Medicine in Asia (LC-SCRUM-Asia) has partnered with Thermo Fisher Scientific Inc. to speed molecular profiling in two major studies. The project now uses Waltham, Mass.-based Thermo Fisher’s Ion Torrent Genexus system and Oncomine Precision assay as the sole system for conducting next-generation sequencing (NGS) to improve personalization of therapeutic approaches and better understand drug resistance in non-small-cell lung cancer (NSCLS). Read More
More than 62% of the volume and 63% of the projected values of med-tech deals completed in 2020 are for one of two things: COVID-19 diagnostics and devices or digital health technologies that fall outside of the pandemic efforts. As of late September, BioWorld has tracked 1,012 deals this year – including licensings, collaborations and joint ventures – valued at $3.67 billion, as well as 272 completed mergers and acquisitions valued at $8.53 billion. Read More
Medtronic plc has unveiled its latest buy this year with the planned acquisition of Avenu Medical Inc., which focuses on the endovascular creation of arteriovenous (AV) fistulae for patients with end-stage renal disease (ESRD) undergoing dialysis. The two did not disclose the terms of the transaction. Read More
Sentiar Inc. received U.S. FDA clearance for its holographic guidance system, known as Commandep, for use in cardiac ablation procedures. The system allows electrophysiologists (EPs) to visualize 3D electroanatomic models in real-time, using augmented reality (AR), to seamlessly navigate invasive procedures. “The Commandep is intended for use as a medical imaging system that allows the review, analysis, communication and media interchange of multidimensional digital images,” Berk Tas, Sentiar’s CEO, told BioWorld. Read More
The COVID-19 pandemic has not run its course, but the U.S. FDA is already working on a plan for handling devices in the period after the public health emergency ends. Bill Maisel, chief medical officer at the FDA’s Center for Device and Radiological Health (CDRH), said the agency is thinking through what would have to appear in a guidance for a transition that may span a number of months, providing industry with some much-needed breathing room. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Becton Dickinson, Genetron, Ka Imaging, Perkinelmer, Sentiar, Vexos. Read More
Keeping you up to date on recent developments in orthopedics, including: SCS reduces pain and motor symptoms in PD patients; Is rheumatoid arthritis two different diseases?; Lockdown impact: Worsening symptoms for people with bone, joint and muscle pain. Read More
