Tesseract Health Inc. has closed an oversubscribed series B financing, reeling in $80 million with support from Foresite Capital, Glenview Capital and Opaleye. The proceeds will be used to advance the company’s Tesseract Ic eye-imaging diagnostic technology platform, including U.S. and overseas regulatory clearances. This is the first independent financing round for the Guilford, Conn.-based startup, which is developing a platform capable of diagnosing a range of diseases without a single blood draw. The company received prior seed funding as part of the 4Catalyzer med-tech incubator. Read More
A team led by researchers at the Institute of Bioelectronic Medicine at The Feinstein Institutes for Medical Research, the research division of New York’s Northwell Health, developed a long-term implant model for vagus nerve stimulation (VNS) in mice that enables study of bioelectronics in chronic disease. The research was published in Elife, with a full description of the surgical technique and methods for calibrating the stimulation dose to enable other labs to use the methods to advance bioelectronic medicine. Read More
The FDA reported a new streamlined pathway for diagnostic testing as part of a serial testing program using pooled samples, a pathway that should enable the further reopening of the economy. However, the FDA’s Tim Stenzel said April 21 that this new pathway relied on accumulated data for molecular testing, and that the agency lacks sufficient data to provide a similar mechanism for this use of antigen tests. Read More
HONG KONG – Celltrion Inc. continues its quest to take its Diatrust COVID-19 Ag Rapid Test overseas, after receiving the FDA’s emergency use authorization (EUA). The Incheon, South Korea-based company also submitted results of clinical trials in which 450 people throughout the U.S. were tested between February and March 2021 to the regulator, with the trial results currently under review. Read More
Location, location, location. Not only is that the mantra for real estate, it often is seen as an answer to diversifying clinical trials. But having a trial site in or near an underserved community is no guarantee of a diverse study population, as health care disparities can be a more pervasive issue than location. That was one of the lessons learned from the development of Celltrans Inc.’s donislecel at the University of Illinois-Chicago. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Affirmxh, Atlas Genomics, Axonlab, Baxter, Cathmedical Cardiovascular, Delcath Systems, Endpoint Clinical, Labcorp, Lifeconnect, Movement Interactive, Opsens, Pixcell Medical, Prevencio, Qiagen, Quick Tube Medical, Red One Medical, Sherlock Biosciences, United PPE, Xphyto. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biostable Science & Engineering, Cerus Endovascular, Empowered Diagnostics, Enzo Biochem, Johnson & Johnson Vision, Medtronic. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: USPSTF sees no reason to recommend screening for AF; Two senators press for UDI data in Medicare claims; Medtronic blood pump console recalled; Federal Circuit affirms PTAB in Cerner/Clinicomp patent dispute. Read More
Keeping you up to date on recent developments in orthopedics, including: 3D biomaterial used as 'sponge' for stem cell therapy to reverse arthritis; New biomaterial regrows blood vessels and bone, RCSI research; Without major changes, gender parity in orthopedic surgery will take two centuries. Read More
