Posts by cstephenson@legacymedsearch.com
SMART Medical Systems Receives FDA Clearance for Its G-EYE Colonoscope
SMART Medical Systems Ltd., a developer and manufacturer of innovative endoscopy products, announced that the FDA issued 510(k) clearance for its flagship product, the G-EYE® Colonoscope. The G-EYE® colonoscope is a standard colonoscope which SMART remanufactures by installing its proprietary G-EYE® balloon on the distal bending section of the colonoscope. During colonoscopy, the G-EYE® colonoscope is inserted in the…
Read MorePhilips Receives FDA Clearance for the Use of its Ultrasound Portfolio to Manage COVID-19-Related Complications
Royal Philips, a global leader in health technology, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market a wide range of its ultrasound solutions for the management of COVID-19-related lung and cardiac complications. Handheld and portable ultrasound solutions in particular have become valuable tools for clinicians…
Read MoreFDA Approves Emergency Use of A&R Tarpaulins’ Patient Isolation Transportation Unit (PITU)
AR Tech, a division of A&R Tarpaulins Inc., an aerospace and medical equipment manufacturer, received emergency approval for the use of its Patient Isolation Transportation Unit (PITU) by the Food and Drug Administration. PITU is designed to temporarily isolate and transport patients with confirmed or suspected COVID-19 infection. “PITU is a game changer in this fight…
Read MoreSmith & Nephew launches new JOURNEY II Unicompartmental Knee System
Smith+Nephew, the global medical technology business, today announces the launch of its new JOURNEY II Unicompartmental Knee (UK) System. Built on the heritage of one of the most clinically successful partial knees,1,2 and paired with proprietary OXINIUM™ Technology, JOURNEY II UK is designed to help patients rediscover their normal life. JOURNEY II UK provides a highly personalized…
Read MoreNew Ergotron CareFit Pro Medical Cart Improves Caregiver Comfort, Efficiency
The new CareFit™ Pro Medical Cart from Ergotron can help improve caregiver comfort, streamline workflows and create better patient experiences. Developed based on years of research and insights from caregivers, CareFit Pro combines a highly mobile and adjustable design with a broad feature set to help caregivers be efficient and comfortable in their jobs. The cart also…
Read MoreThermedical’s Groundbreaking SERF Ablation System Earns FDA’s Breakthrough Device Designation
Thermedical®, a developer of thermal-ablation medical systems to treat ventricular tachycardia (VT), today announced that it has received Breakthrough Device Designation from the U.S. Food & Drug Administration (FDA) for its Saline Enhanced Radiofrequency (SERF) Ablation system and Durablate® catheter. The FDA Breakthrough Devices Program is intended to help patients receive more timely access to technologies that…
Read MoreButterfly Network, Inc. is Bringing Ultrasound into the Home with Telemedicine
Butterfly Network has developed and is rolling out a new version of TeleGuidance™, their ultrasound-based telemedicine platform. TeleGuidance brings medical imaging to telemedicine. It leverages an array of leading-edge and easy-to-use augmented reality guiding tools. It allows trained practitioners to perform an ultrasound scan without being next to the patient. “We are grateful for the…
Read MoreZebra Medical Vision Secures its 5th FDA Clearance, Making Its Vertebral Compression Fractures AI Solution Available in the U.S.
Zebra Medical Vision, the deep-learning medical imaging analytics company, announces today its fifth FDA 510(k) clearance for its Vertebral Compression Fractures (VCF) product. The company’s latest AI solution automatically identifies findings suggestive of compression fractures, enabling clinicians to place patients that are at risk of osteoporosis in treatment pathways to prevent potentially life-changing fractures. The…
Read MoreFDA and CDC Drawing Up Plan to Restart Routine Facility Inspections
Amid the coronavirus outbreak reaching pandemic level in March, FDA stopped routine inspections of domestic and international facilities. Under the revised policy, the agency would perform inspections seen as “mission critical” while relying on off-site monitoring and the commitment of companies to quality in the absence of in-person regulatory oversight to maintain standards during the…
Read MoreNevro Announces CE Mark Approval of Senza Omnia Spinal Cord Stimulation System to Treat Chronic Pain
Nevro Corp., a global medical device company that is providing innovative, evidence-based solutions for the treatment of chronic pain, today announced it has received CE mark approval for the Senza® Omnia™ Spinal Cord Stimulation (SCS) system. “Following a successful launch in the United States late last year, we are excited to now have approval for the Senza Omnia…
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