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. Read More
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.” Read More
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. Read More
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. Read More
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. Read More
New hires and promotions in the med-tech industry, including: Bioventrix, Exponential AI, Iron Bow, Midiagnostics, Real Chemistry, Shape Memory Medical, Signify Health. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Guardant Health, Haemonetics, Intersect ENT, Medtronic, Paige.Ai, Skylinedx. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Arup Laboratories, Conventus-Flower, Cynosure, Evon Medics, Genome Medical, Midiagnostics, Myellevate, Patientsafe Solutions, Red One Medical, Specific Diagnostics, Techcyte, Vocera. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Motus GI. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: CMS tacks three years onto CJR, revises target price calculation; Connect for Health Act back in play; More bezel troubles for Alaris 8100; CMS announces two meetings for FY 2022 lab fee schedule. Read More
Keeping you up to date on recent developments in neurology, including: Detecting brain damage in babies earlier with new infrared scanner; VR treatment for PTSD to be evaluated in clinical trial; NIH study identifies diverse spectrum of neurons that govern movement. Read More
