FDA Grants De Novo Clearance To Miach Orthopaedic’s BEAR Implant For Repair Of ACL Tears
The Bridge-Enhanced ACL Repair Implant de novo-cleared by the FDA addresses a common football injury suffered by US athletes.
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Miach Orthopedics expects to soon earn US FDA de novo clearance for its Bridge-Enhanced ACL Repair (BEAR) technology as an alternative to conventional anterior cruciate ligament reconstruction surgery. Trials have shown BEAR helps restore torn ACLs to normal strength and function.
Tom McLain tells how the new MCIT policy from the US Medicare agency – and winning support from Congress – will guarantee Medicare coverage for his company’s product, an artificial intelligence-enabled in vitro diagnostic platform.
Patient Safety Advocate Raises Alarm Over HHS/FDA Push That Could Exempt 80+ Devices From Regulation
National Center for Health Research president Diana Zuckerman is concerned about a new joint notice from the US HHS and the FDA designed to deregulate a slew of devices and tests.