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.
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.
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.
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.
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.
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.
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.