Two judges with the U.S. Court of Appeals for the Federal Circuit sided with the Patent Trial and Appeal Board (PTAB) in a patent dispute between Oticon Medical and Cochlear, but the third judge, Pauline Newman took issue with the decision. Newman said the majority applied “an improper analytical technique” to determine that the preamble to a patent does not limit the related claims, despite that prior art cited to dispute the patent had been “disavowed by the preamble.”
Waltham, Mass.-based Thermedical Inc. has received a breakthrough device designation from the U.S. FDA for its saline enhanced radiofrequency (SERF) ablation system and Durablate catheter in the treatment of ventricular tachycardia (VT). The system uses a new means of biological heat to precisely deliver ablation therapy to the heart.
Quidel Corp., of San Diego, has scored another win at the U.S. FDA, receiving emergency use authorization (EUA) for the Lyra Direct SARS-CoV-2 Assay to allow direct sample processing. What’s special about this assay is that it does not require an up-front sample extraction. Instead, it uses a reformulated buffer that replaces that process with a simple 10-minute heat step, saving about 50 minutes in processing time.
The latest global regulatory news, changes and updates affecting biopharma, including: Cybersecurity and Infrastructure Security Agency, EMA, European Commission, FBI, FDA, Glaxosmithkline, National Institute for Health and Care Excellence, NIH, U.K. National Cyber Security Agency, U.S. Department of Justice.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Athos KT, Blue Flame Medical, Glaxosmithkline, Harsco, Lymol Medical, Pfizer, Stericycle, Vir Biotechnology.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Archerdx, Bio-Rad, Cochlear, Invivoscribe, Ortho, Quidel, Theradiag, Thermedical.
Responding to COVID-19’s wakeup call as it exposes the risks of relying heavily on foreign biopharma supply chains, the U.S. Department of Health and Human Services (HHS) signed a four-year, $354 million agreement with a team of private industry partners, led by Phlow Corp., to expand U.S. manufacturing of essential medicines at risk of shortage during the pandemic and in future public health emergencies.
LONDON - EMA Director General Guido Rasi has hit out at the lack of coordination in COVID-19 clinical trials, questioning if the huge number of small studies that are running will support regulatory decision-making.
Edwards Lifesciences Corp. has gained a CE mark for its Pascal transcatheter valve repair system to treat tricuspid regurgitation (TR). It was previously approved for mitral regurgitation treatment. Due to the pandemic, Edwards has paused new enrollments in its ongoing mitral and tricuspid pivotal clinical trials.