FDA

"Both the CYGNUS™ MoRe® ACP and the MiRus® 3DR™ Lateral Lumbar Interbody Fusion system with Integrated MoRe® plate fixation are major accomplishments in the global spine market, as we strive to develop products that are best in class with a resolve to provide meaningful innovations to surgeons that improve patient outcomes." stated Jay Yadav, MD, Founder and CEO MiRus.   

“The best in class Bonhawa system greatly improves patient care while enhancing efficiency for clinicians,” said Bryan Liu, PhD, CEO of Telesair. “It represents a significant milestone in that it is a more cost-effective, user-friendly option for treating respiratory conditions. Bonhawa is the only standalone high flow oxygen therapy system designed by experts in ventilation. Our team has decades of experience developing and commercializing revolutionary respiratory solutions and collaborated to create this efficient, easy-to-use system. I am very proud of the organization for achieving both MDR/CE and FDA clearance in less than one year.”

Endobronchial ultrasound with transbronchial needle aspiration ( EBUS-TBNA ) is used for the diagnosis and staging of lung cancer. This procedure is performed by inserting a long, flexible fine needle through a bronchoscope for biopsy and pathological analysis. The cellular material collected can be viewed under a microscope to determine if a mass is malignant and identify tumor-specific mutations to guide treatment.

VySpine also received a 510(k) clearance from the FDA for its VyLam System, which is indicated for use in laminoplasty of the lower cervical and upper thoracic spine (C3-T3) in skeletally mature patients.

″The use of spinal cord stimulation to support a subset of the diabetes population is an important advancement for one of the fastest growing chronic conditions in the world,″ said Jim Cassidy, president of Neuromodulation, Boston Scientific. ″This expanded indication is another testament to our commitment to delivering a robust portfolio of interventional pain solutions that provides physicians with more treatment choices to help their patients find relief.″

Jason Loveridge, Ph.D., CEO of 4SC, commented: “Receiving orphan drug designation for resminostat provides us with a number of important benefits, most crucially 7 years’ market exclusivity in the US, a key foundation of our efforts to commercialise Kinselby.  We are currently preparing a marketing authorisation application for Kinselby in the EU, which remains on track for submission in Q1 2024.”

By expanding the range of FDA-cleared surgical applications for MONTAGE, this latest milestone positions Abyrx to build upon the more than 25,000 units of MONTAGE that have been used to date by surgeons in trauma, orthopedics, sports medicine, foot and ankle, and craniomaxillofacial procedures.

9MW3011 has been approved to clinical study by NMPA and FDA, respectively. The first person has been dosed in the clinical study in China in March, 2023.

"We are pleased to gain the QIDP and Fast Track designations for DFI as recognition that contezolid and contezolid acefosamil are novel new agents to meet an important unmet need in this common and challenging infection", stated Dr Zhengyu Yuan, Chief Executive Officer at MicuRx.