Latest medtech regulatory news

US commercial availability of BEAR Implant for ACL tears

Miach Orthopaedics’s BEAR Implant is now commercially available in select U.S. cities for the treatment of anterior cruciate ligament (ACL) tears. The BEAR Implant was also awarded a Popular Science Best of What’s New Award for representing a significant step forward in health.

The BEAR Implant is the first medical technology to clinically demonstrate it enables healing of a patient’s torn ACL.

The proprietary, bio-engineered BEAR Implant has several benefits over ACL reconstruction: restores ACL quality and size similar to the non-injured ACL; results in faster recovery of muscle strength; and has better patient satisfaction with being ready to return to sports. The BEAR Implant doesn’t require a graft, eliminating the need for a second wound site to heal and worries about donor graft quality or risk of disease.

MoveAgain receives Breakthrough Device designation

The U.S. Food and Drug Administration (FDA) granted Blackrock Neurotech Breakthrough Device designation for its MoveAgain brain computer interface (BCI) system, hoping to provide immobile patients the ability to control a mouse cursor, keyboard, mobile device/tablet, wheelchair, or prosthetic device simply by thinking. Blackrock’s portable MoveAgain BCI could offer patients new possibilities for improved mobility and independence – such as returning to work, participating in leisure activities, and communicating more effectively and quickly. The MoveAgain BCI system is an array implanted in the brain decoding intended movement from neuronal activity. Those signals are then transmitted wirelessly to an external device, such as a cursor or wheelchair, providing people with control of their external environment.

FDA grants clearance for off-the-shelf ClearFit cover

Longeviti Neuro Solutions was granted a 510(k) clearance by the U.S. Food and Drug Administration (FDA) for ClearFit OTS (off-the-shelf). With the new 510(k) clearance, Longeviti is the first solutions provider to bring an optically clear, polymethyl methacrylate, OTS cranial product to the market, enabling surgeons to address urgent, immediate functional, and reconstructive clinical needs with the latest technological advancements in neurosurgery. ClearFit OTS, made of polymethyl-methacrylate (PMMA), a sonolucent, biocompatible material, provides an implantable prosthesis to correct and restore cranium bone voids, enabling the use of ultrasound for post-operative imaging.

Turnkey robotic-assisted surgical system

Smith+Nephew launched CORI handheld robotics, an advanced system for total and partial knee arthroplasties.

The CORI system is a compact and fully mobile solution incorporating a 3D intraoperative imaging system with an advanced robotic sculpting tool. The robotic system allows surgeons to measure, plan, and perform a knee surgery personalized to the patient’s individual anatomy in theatre. The Smith+Nephew system is more compact than alternative robotic systems, has minimal set up time, and is portable.