The U.S. FDA granted Gtx Medical BV a breakthrough device designation for its implantable Go-2 Targeted Epidural Spinal Stimulation (TESS) system. The device enabled patients who had sustained traumatic spinal cord injuries to regain voluntary control over previously paralyzed muscles and walk again four or more years after paralysis, according to a study previously published in Nature. Read More
The impact of the COVID-19 pandemic has reached into quarters that are not historically problematic for makers of diagnostics, including China’s import and export practices for test kits. According to one caller on an FDA diagnostic town hall, export officials in China have a blacklist and a whitelist for test kits, but there is some dispute as to whether kits that are eligible for distribution in the U.S. can get off the blacklist unless that kit is specifically called out via the emergency use authorization (EUA) program. Read More
Cue Health Inc. scooped up $100 million in a series C round to support the launch of its rapid molecular testing platform. The funds will be used to finalize the development and validation of the Cue Health Monitoring System and Cue Test Cartridges, as well as to scale up manufacturing operations. Read More
Whole genome sequencing is not part of treating patients in practice – or even involved in most clinical trials of drug candidates. But C2i Genomics Inc. is working to make that a reality. It applies pattern recognition to whole genome sequencing to create an individualized fingerprint for a given patient’s tumor. The New York-based startup has raised a $12 million series A round to back the development of its technology, which came out of Cornell and the New York Genome Center. Read More
Before the lessons of COVID-19 fade into yesterday’s news, Congress should start preparing for the next pandemic, Sen. Lamar Alexander (R-Tenn.) is advising. As the chair of the Senate Health, Education, Labor and Pensions Committee, the senator issued a white paper Tuesday identifying areas that must be addressed. Read More
New hires and promotions in the med-tech industry, including: Inogen, Onlume, Pacific Biosciences of California, Renovacare, Rti Surgical Holdings, Scipher Medicine. Read More
Med-tech firms raising money in public or private financings, including: Cardiovascular Systems, Mesa Laboratories, Pulse Biosciences, Varex Imaging. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Baxter, Bioaffinity Technologies, Corwave, Inspiremd, Reflow Medical, Saranas. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: AACC, Akadeum, Calmare Therapeutics, Cota, Curadigm, Healgen, Helixbind, Hematogenix, Huma, Menarini Silicon Biosystems, Nanobiotix, Nanocellect, Neuspera, Orasure Technologies, Roche, Tyto Care, Vivera Pharmaceuticals. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Chromacode, Illumina, Quidel. Read More
Keeping you up to date on recent developments in orthopedics, including: Researchers restore injured man's sense of touch using brain-computer interface technology; Down to the bone: Understanding how bone-dissolving cells are generated; Improved MRI scans could aid in development of arthritis treatments. Read More
