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.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Apollo Health, Aziyo Biologics, Circle Medical Technologies, Clinical Genomics, Echosens, Fio, Gelesis, Iwatani, Precision Healing, Premier, Readout Health, Relay Medical, Sanara, Sintx, Stemonix, Stryker, United Wound and Skin Solutions, Well Health Technologies, Wright Medical.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Adaptive Biotechnologies, Glympse Bio, Helio Health, Inari Medical, Pq Bypass.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aerie, Agios, Amgen, Bayer, Biomarin, Boehringer Ingelheim, Chiesi, Heron, Innate, Menari, Moderna, Roche, Samsung, Shionogi, Sobi, UCB, Viiv.
The competitive din in the vocal sound diagnostic space rose to new levels as Sonde Health Inc. launched a developer portal to enable other companies to incorporate its vocal biomarker-based health check technology into their apps. Sonde joins a growing number of companies and academic labs around the world talking up the ability of voice recordings to detect a surprising range of diseases.
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.
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