Rebus Biosystems Inc. has closed a $20 million series B fundraising round. The financing round was led by Illumina Ventures with participation by Lifecore Partners, Ncore Ventures, Xolon Invest, Ctk Investments, Ray Co. Ltd., Seegene Medical Foundation, Labgenomics Co. Ltd. and Timefolio Asset Management. Rebus builds spatial omics tools, assays and platforms. The company plans to use the new funding to support commercialization of its spatial omics solution and expansion of its marketing, sales, research, and product development teams, said Rebus CEO Paul Sargeant. Rebus plans to launch its automated, standalone Rebus Biosystems instrument and optimized assay kits for spatial transcriptomics early in 2021. Read More
Johnson & Johnson (J&J) said it will deliver its differentiated value propositions for patients Thursday as it provided details on its Ottava platform during its Virtual Medical Devices Update. Analysts appear to have left the meeting with a good impression. “We came away impressed with JNJ's digital surgery vision & holistic approach,” wrote Cowen’s Josh Jennings. Read More
Eargo Inc., a medical device company specializing in hearing aids, reported $18.2 million in third quarter revenue, driven by sales of the company’s Neo Hifi hearing aid system and a decrease in the sales return accrual rate. Revenue was up 135% over the third quarter of 2019. Read More
PERTH, Australia – It was already going to be a busy year for Australia’s Therapeutic Goods Administration (TGA) as it planned to implement the final wave of device reforms in 2020 before the COVID-19 pandemic hit. The delay to the EU Medical Device Regulation (MDR) as a result of the pandemic will mean that Australia will also push back many of its device reforms for another year, said John Skerritt, the TGA’s deputy secretary of the Health Products Regulation Group. Read More
The U.S. FDA’s device center is re-examining its approach to public safety communication, but Mark Leahey of the Medical Device Manufacturers Association said on a recent webinar that the FDA sometimes goes silent after an initial consultation with device makers about a safety signal. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: J&J subsidiary agrees to settle off-label promotion allegations; FDA says ‘vulnerabilities persist’ in limited CDS programs. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Armis Biopharma, Hologic, Penumbra, Pixium, Think Surgical. Read More
Keeping you up to date on recent developments in neurology, including: Wireless chip developed to improve brain research; Diabetes increases damage around amyloid plaques in Alzheimer’s; Smartphone keystrokes show promise in monitoring progression of MS. Read More
