Regulatory Approvals

Ekso Bionics (Nasdaq:EKSO) announced that it received FDA 510(k) clearance for its EksoNR robotic exoskeleton. Richmond, California–based Ekso Bionics designed the EksoNR technology for use with...

The StrivePD app uses Apple's Movement Disorder API to track tremors and uncontrolled body movement. Brain data startup Rune Labs announced Tuesday it received FDA 510(k) clearance to use...

EarliTec Diagnostics, Inc. (“EarliTec”), a digital health company developing novel diagnostic and therapeutic products for children with autism spectrum disorder (ASD) and early childhood...

Zavation Medical announced that it received FDA 510(k) clearance for its eZspand lateral expandable lumbar interbody fusion device. Flowood, Mississippi-based Zavation designed the eZspand lateral, part...

The device includes an eInk screen that allows physicians and patients to interact with the wearable. The US Food and Drug Administration (FDA) has approved Medicalgorithmics’ ECG...

LOBO-7 and LOBO-9 are intended for use in 5mm to 7mm and 7mm to 9mm diameter vessels, respectively. Okami Medical has received 510k clearance from the US...

Aurora Spine Corporation ("Aurora Spine" or the "Company") (TSXV: ASG) (OTCQB: ASAPF), a designer and manufacturer of innovative medical devices that improve spinal surgery outcomes,...

Abbott  announced that it received FDA clearance for its next-generation FreeStyle Libre 3 continuous glucose monitor. FDA clearance for the latest iteration of the company’s...

Medtronic  announced that it received FDA approval for its In.Pact 018 paclitaxel-coated balloon catheter. Fridley, Minnesota-based Medtronic’s In.Pact 018 paclitaxel-coated percutaneous transluminal angioplasty (PTA) balloon...