FDA OKs Opus' arthroscopic rotator cuff repair technology:
This article was originally published in Clinica
Executive Summary
Opus Medical has launched in the US its totally arthroscopic rotator cuff repair technology, after gaining FDA 510(k) clearance for the final component of the system. The minimally invasive AutoCuff device provides surgeons with a "knot-free" method of suturing tissue to bone, which could lower procedure costs by minimising surgery time, says the San Juan Capistrano, California firm. It is also expected to reduce patient rehabilitation time. The remaining element of the product to gain approval was the reusable SmartStitch handle component.
You may also be interested in...
Generic Or Innovator? Sandoz Sues CMS Over Potential Change In Rebate Classification
Sandoz argued against paying higher rebates for two of its drugs via the Centers for Medicare and Medicaid Services’ Medicaid drug rebate program in a US court six years after the suggestion was first made.
Ultrahuman Expands Wearable Medtech Production Into US After $35M Funding Round
Firm operating in London, India and United Arab Emirates says its “Ultra Factory” will open in Indiana within the next six months with end-to-end production based on its operational facility in India.
Cochlear’s Osia System Receives Expanded FDA Clearance For Use In Younger Children
Kids ages 5 and up now can benefit from Cochlear’s Osia implant and sound processor, indicated for hearing loss, mixed hearing loss and single-sided sensorineural deafness.