MedTech News
FDA Clears AIOMEGA’s AIO Breathe, for Treatment of Obstructive Sleep Apnea
TYLER, Texas–(BUSINESS WIRE)– AIOMEGA, a Texas biomedical company, announced that AIO BREATHE, their medical device that treats Obstructive Sleep Apnea, has been cleared by the Food and Drug Administration.
Nevro Receives FDA 510(k) Clearance to Use SI Fixation System Without Need to Include Lateral Screw
Nevro1™ Proven to Immediately Transfix Sacroiliac (SI) Joint to Allow for Long-term SI Joint Fusion
Sonus Microsystems unveils latest ultrasound tech
Sonus Microsystems has unveiled its latest ultrasound technology, delivering remote diagnostic imaging, without the need to go to a clinic or hospital
New Models of PENTAX Medical i20c Video Endoscope Series Obtain CE Marks
TOKYO, Feb. 27, 2024 /PRNewswire/ — PENTAX Medical, a division of HOYA Group, have obtained CE marks for new models of PENTAX Medical i20c Video Endoscope Series – PENTAX Medical Video Colonoscope EC34-i20c, PENTAX Medical Video Upper GI Scope EG27-i20c and R/L Knob Adaptor OE-B17.
Virtual Incision wins FDA nod for miniature MIRA surgical robot for use in colectomies
Virtual Incision announced that the FDA granted marketing authorization to its MIRA miniaturized surgical robotic system.
Zimmer receives FDA clearance for robotic shoulder system
The clearance poises the orthopedics company to be first to market with robotic-assisted shoulder replacement surgery.
Tenon Medical, Inc. Announces Issuance of Notice of Allowance of Patent Application Which Further Enhances Important Claims for its Sacroiliac Joint Implant
Allowance for U.S. Patent Application Serial Number 18/107,536 for Tenon’s Catamaran® SI Joint implant for stabilizing a dysfunctional sacroiliac (SI) joint.
FDA Grants Humanitarian Device Exemption Approval to SeaStar Medical’s Selective Cytopheretic Device for Pediatric Acute Kidney Injury
For use in children weighing 10 kilograms or more with acute kidney injury (AKI) due to sepsis or a septic condition requiring kidney replacement therapy (KRT).