Pear Therapeutics Inc. filed for bankruptcy protection under chapter 11 to buy time to sell its assets. The company was the first-to-market for prescription digital therapies, with three PDTs gaining regulatory nods from the FDA: Reset for substance use disorder, Reset-O for opioid use disorder and Somryst for insomnia. Reset-A received breakthrough device designation in 2021. The Reset therapies are approved for use in conjunction with medication therapy or other outpatient therapy for substance use. Read More
Infandx AG has had an abrupt change of strategy after discontinuing development of an umbilical cord blood biomarker test, which was intended to diagnose brain injury in newborns caused by a lack of oxygen before or shortly after birth. Read More
Sometimes the simplest solution is the most elegant solution, and that is certainly the case for Livac Pty Ltd.’s minimally invasive liver vacuum retractor device known as the Livac. Read More
The International Medical Device Regulators Forum (IMDRF) has posted a guidance that spells out the use of a common document for regulatory review for member regulatory authorities, a mechanism that might ease the lives of manufacturers across the globe. Read More
In December 2013, the U.S. FDA held an advisory hearing on spinal spheres used in intervertebral fusion procedures, a hearing that generated a recommendation that the agency classify these devices as class III devices. The agency finally followed through on that recommendation with a final rule that requires a PMA filing for these devices, concluding a process that took much longer than the typical rulemaking. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Genome Insight, Myomo, Omni Components, Ryzur, Ultima Genomics, Vander-Bend, Virgo Surgical Video. Read More
