FDA Clears Device to Remove Dead Pancreatic Tissue
The US Food and Drug Administration (FDA) has approved the EndoRotor System (Interscope, Inc) for removal of necrotic tissue in patients with walled-off pancreatic necrosis (WOPN)."This...
Medtronic gets FDA Clearance for Midas Rex™ Drills with Mazor™ Robotic System
The Mazor™ platform now provides surgeons with unprecedented procedural integration.Global leader in medical technology, Medtronic plc, has announced that the U.S. Food and Drug Administration...
Advanced Bionics Receives FDA Approval for Marvel Cochlear Implant Platform and World’s First Sound Processor for Children
Collaboration with Phonak brings breakthrough Marvel hearing technology to adult and pediatric cochlear implant wearers.Advanced Bionics (AB), a global leader in cochlear implant technology,...
Respiratory Health company AireHealth lands 510(k) for connected nebulizer
The nebulizer called VitalMed is able to connect to a corresponding app designed to help patients track their symptoms.AireHealth, a Floridian startup focused on...
Five breakthrough device designations granted by the FDA in November
FDA Breakthrough Device Designations made in November included a sleep apnoea treatment to rival the CPAP machine and a neurostimulation migraine treatmentThe previous month...
AliveCor gets FDA clearance for algorithms to detect more cardiac conditions
The startup, which has developed a portable ECG device, received clearance for algorithms to detect more cardiac conditions, such as premature contractions.As more companies...
Braid Health gets FDA approval for AI-powered diagnostic platform
Braid Health has made sure about FDA clearance for its AI-fueled diagnostic collaboration programming, improving diagnostic access and decreasing expenses for huge healthcare frameworks,...
NICO.LAB ready to revolutionize U.S. stroke care following FDA clearance
The U.S. Food and Drug Administration (FDA) has cleared StrokeViewer LVO, NICO.LAB’s artificial intelligence powered solution in stroke care. StrokeViewer enables physicians to provide...
Armis Biopharma announces FDA 510(k) clearance for VeriFixx small bone implant
VeriFixx is designed to make surgical corrections of this kind more accessible to patients through shorter time to ambulation, shorter overall recovery time and...