Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Medtronic plc., Molli Surgical.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Canon Medical Systems USA, Closedloop.ai, Cradle Genomics, Echelon Diagnostics, Ocular Therapeutix, Precipio, Raysearch Laboratories.
New hires and promotions in the med-tech industry, including: Apollo Endosurgery, Arch Therapeutics, Beyond Air, Bone Health, Deep Genomics, Guardant Health, Heartstitch, Intervenn Biosciences, Nanox, Peak Nanosystems.
Ceribell Inc. amassed $53 million in a series C fundraising round to broaden the footprint for its noninvasive brain monitor in U.S. hospitals and expand indications for its Rapid Response EEG. Longitude Capital and The Rise Fund led the round.
Onlume Inc. has secured $7 million in a series A round led by Cambridge Investment Group. Other investors participating in the round included WARF Ventures (Wisconsin Alumni Research Foundation) and Wisconsin Investment Partners. The proceeds will support the commercial launch of the company’s FDA-cleared fluorescence-guided surgery (FGS) imaging system.
The negotiations for the next device user fee agreement are well underway, and there are signs that the FDA is looking for a significant boost in user fees from device makers. However, Rep. Anna Eshoo (D-Calif.) told members of the MDMA that no member of Congress should believe that user fees relieve Congress of its responsibility “for funding the agency in a robust way.”
PARIS – Urgo Group SAS has just been awarded $27.7 million in financial support from the French government, to help develop artificial skin for treating deep skin wounds and massive burns.
Researchers have gained new insights into what makes for transplantable livers – and what doesn’t. In a clinical trial of 12 livers, a team from Massachusetts General Hospital showed that both livers with high fat content and those without could be viable for transplantation.