Acutus Medical Inc. posted strong results for the third quarter of 2020, despite the ongoing uncertainties of the COVID-19 pandemic. Sales for the quarter totaled $3.2 million, up 180% sequentially and 391% when compared with the same period in 2019. Read More
TORONTO – A Canadian plant-based, cellulose scaffold implant for regenerating healthy spinal cord tissue has received U.S. FDA breakthrough device designation. The designation will enhance the process by which Ottawa-based Spiderwort Inc. interacts with the FDA during regulatory review of the Cellubridge implant, said Spiderwort CSO and cofounder Andrew Pelling, speeding its way to clinical trials. Read More
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. Read More
The U.S. FDA granted 510(k) clearance to Lantheus Holdings Inc.'s artificial intelligence (AI)-enhanced automated bone scan index (aBSI) product for prostate cancer on GE Healthcare's Xeleris platform. ABSI improves quantification and management of disease progression in advanced prostate cancer patients. Read More
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. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Adaptive Biotechnologies, Glympse Bio, Helio Health, Inari Medical, Pq Bypass. Read More
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. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Lantheus. Read More
Keeping you up to date on recent developments in neurology, including: Individualized brain stimulation therapy improves aphasia in stroke survivors; Weekly physical activity may help prevent Alzheimer’s in people with mild cognitive impairment; Diagnosing Parkinson’s via mitochondria interaction networks. Read More
