Motus GI Holdings Inc. undertook further lifesaving measures to survive into 2024 as it continues to seek strategic and financial alternatives that will enable the company to accelerate commercialization of its Pure-Vu endoscopy system. CEO Tim Moran became chairman of the board as former CEO—and current President, Chief Operating Officer and director—Mark Pomeranz added the CEO position to his portfolio. Read More
Abbott Laboratories Inc. landed U.S. FDA clearance for its Freestyle Libre 3 integrated continuous glucose monitoring system (CGM)’s reader device a bit earlier than expected. With the regulatory greenlight for the durable medical equipment component received, the company is now pursuing coverage by the CMS for the entire Freestyle Libre 3 system. The system’s sensor received FDA clearance in May 2022. Read More
Andera Partners led a $48.5 million series A financing round for Bioventrix Inc. which will allow the medical device company to complete its premarket approval (PMA) submission for the Revivent TC system. Andera joined Cormorant Asset Management and Squarepoint Capital as new investors in Bioventrix. Existing investors, Taglich Brothers Inc. and Richmond Brothers, also contributed to the fundraising. Read More
Liquid biopsy company Epic Sciences Inc. reeled in $24 million in a series G financing co-led by Deerfield Management and Arsenal Capital Partners. The funds will be used to build the commercial infrastructure needed successfully market DefineMBC, its comprehensive blood-based test for patients with metastatic breast cancer. Read More
The U.S. FDA has finalized a guidance for class II devices for treatment of peripheral artery disease that excludes drug-coated balloons (DCBs), which are regulated as class III devices. One of the issues the med-tech industry may have with the guidance is that it fails to acknowledge that a device accessory is in some instances exempt from the requirements of the 510(k) program even though the agency has a policy specific to that consideration. Read More
The growing number of people taking up more active sports in China is powering the global market for orthopedic trauma devices through a surge in demand and the emergence of new lines of surgical products, particularly ones that can improve patient outcomes and experience. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aerwave, Autonomous Medical, Avita, Caregility, Keygene, Lucius Partners, Pillar Biosciences, Xandar Kardian. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Clearpoint Neuro. Read More
