Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Chembio, Sofwave.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aspen Dental Management, B. Braun Melsungen, Baxter, Cape Biologix, Clearchoice, Diabeloop, Grifols, Inno-3B, Intralink-Spine, Masimo, Medicrea, Medtronic, Nuprobe, Plantform, Procept Biorobotics, Qiagen, Start Codon, Sun Capital Partners, Terumo.
A Polish/Dutch team of investigators has reported new insights into the structure of the SARS-CoV-2 genome that suggests it could be amenable to both small-molecule and oligonucleotide drugs.
Qiagen NV has started U.S. commercialization of a portable SARS-CoV-2 antigen testing device that can analyze up to 30 patient samples an hour. The Qiareach test features a portable hub device – smaller than a laptop – that can hold up to eight nasopharyngeal swab samples at a time. The test provides a digital readout of the results in two to 15 minutes – with strong positive results taking closer to two minutes and negative results coming back in 15 minutes.
Although the global impact of a novel virus like SARS-CoV-2 has so far reached devastating proportions, it has spurred science at an unprecedented rate with potential vaccines developed under a year now nearing U.S. authorization. But while some may say the end to this pandemic is in sight, an actual date is blurry at best, as manufacturing and supply capabilities muddy the outlook.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Adaptive Biotechnologies, Glympse Bio, Helio Health, Inari Medical, Pq Bypass.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA eyes grant of license for spectrometer for SARS; HQO eyes TAVI/TAVR for low-risk patients; ACLA says testing capacity beginning to strain.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bioelectronics, Perkinelmer, Spiderwort, Wren Laboratories.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA warning letter to company promoting test kits.
