The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Vaccine, diagnostic developers targeted by cyberattacks; Groups make case for extending sequester moratorium; More money needed for global vaccine effort; Russia extends COVID-19 drug, device program.
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.
PERTH, Australia – The COVID-19 pandemic has highlighted the importance of digital health technology, and the Australian government quickly enabled programs in telehealth and e-prescriptions. It now is embracing opportunities to build on this momentum to accelerate the country’s economic digital transformation. Not only will this transformation contribute to Australia’s recovery, but also to its long-term prosperity, said Sue MacLeman, chair of Australia’s Medical Technologies and Pharmaceuticals Industry Growth Centre (MTPConnect), during a recent ANDHealth teleconference.
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.
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.
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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