Ciliatech SAS secured $3.87 million in series A funding to continue developing its second-generation implant to treat open-angle glaucoma. This round was led by its historical shareholders, including BNP Development SAS, Kreaxi SAS and individual investor Bernard Chauvin. “With this additional money, we can continue clinical trials to obtain the CE mark,” Olivier Benoit, co-founder and CEO of Ciliatech SAS told BioWorld.
China’s NMPA gave the nod to Roche Diagnostics (Shanghai) Ltd.’s anti-preferentially expressed antigen in melanoma (PRAME) (EPR 20330) that could help to speed up melanoma diagnosis and improve survival rates.
The new bedside monitor Carescape Canvas will work in tandem with the Carescape One acquisition device also developed by GE Healthcare Technologies Inc. and cleared for sale in the U.S. in 2019. Together, they scale up or down monitoring capabilities based on the acuity of each individual patient and according to the company provide sufficient flexibility to monitor patients across different health care settings within a hospital.
The Feinstein Institutes for Medical Research, the research arm of Northwell Health, landed a $3.4 million grant from the Wellcome Trust to evaluate the use of transcranial magnetic stimulation (rTMS) for schizophrenia. Feinstein will undertake a five-year, double-blind, randomized trial to see whether rTMS improves cognitive or other symptoms of schizophrenia. The technology currently has FDA approval for use in individuals with depression and obsessive-compulsive disorder.
Oso-AI SAS raised $10.7 million to develop its artificial intelligence (AI)-driven augmented ear for frail people and their caregivers. This series A financing round was led by its historical shareholders Innovacom SAS, Novinvest Partners SAS and Breizh-up, which is the co-investment fund of Brittany region financed by the European Regional Development Fund and managed by UI Investment SAS. Cemag Invest Partners SAS has joined these three historical investors. This operation follows a first round of financing of $4.4 million which closed in September 2020.
Cardiex Ltd. won U.S. FDA clearance for its Conneqt Pulse vascular biometric monitor. According to the digital health and wearables company, the device is the first in the world to provide measurements of both brachial blood pressure in the arm and central blood pressure in the heart and aorta, as well as arterial waveform analysis and other clinically relevant vascular biomarkers, outside the hospital, research institutions or clinical trial sites.
For several years, the U.S. CMS has been musing a coverage policy specifically for breakthrough medical devices, and the absence of activity on this front has once again drawn the attention of Congress. Rep. Cathy McMorris Rodgers (R-Wash.), said a representative of CMS had recently appeared before a House subcommittee for the first time in four years, and that the subcommittee is prepared to act on breakthrough devices coverage if CMS doesn’t produce a final rule this year.
Dexcom Inc. posted a 19% increase in first quarter revenues compared to 2022 boosted by a stunning 27% organic growth in sales outside the U.S. With clearance of the G7 device in hand, another record set in new patient starts and coverage of continuous glucose monitoring (CGM) systems by CMS effective this month, the year is shaping up to be quite rosy for the diabetes device company.
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