Beverly, Mass.-based Lexagene Holdings Inc. has developed a genetic analyzer with multiplex testing capability that would enable it to determine whether a patient has COVID-19, influenza or another respiratory infection with one sample. The Lx Analyzer uses a proprietary quantitative reverse transcription polymerase chain reaction (RT-qPCR) method to automatically test for up to 27 pathogens simultaneously, all in about one hour.
The potential for neurological complications, including seizures and stroke, is a growing concern with COVID-19 patients. To ensure rapid diagnosis and treatment, Ceribell Inc., a Mountain View, Calif.-based startup, is deploying its cloud-linked, portable electroencephalogram (EEG) device to enable EEG assessments in minutes in emergency rooms and intensive care units.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Antibodiescheck.com, Medakit, Sonrisa Family Dental.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aethlon, Icotec, Naviswiss, Pear Therapeutics, Sirakoss.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aduro, Align Technology, American Telemedicine Association, Aramark, Archerdx, Bristol-Myers Squibb, China Medical Holdings, Foxconn, Gelesis, Gingko Bioworks, Harvey Nash, Inivata, Medstar Health, Medtech Innovator, Medtronic, Monitorme, Natera, Nephros, One Medical, Philips, Quest Global, Usgi.
Keeping you up to date on recent developments in diagnostics, including: Improving diagnosis of pulmonary hypertension; A web-based COVID-19 assessment tool; Discovering pharmacological enzyme activators.
Countries and health care providers should hope for the best but prepare for the worst as a resurgence of COVID-19 is expected in the fall, just as the influenza season hits.
The COVID-19 pandemic has fueled an unprecedented uptick in telehealth use, from medical and behavioral health services to remote patient monitoring, as federal and state regulators have relaxed certain policy restrictions to increase access to care. Sen. Lamar Alexander (R-Tenn.) recommended in a Senate hearing that certain temporary policy changes, such as elimination of the “originating site” rule and expansion of Medicare- and Medicaid-covered telehealth services, should be lasting to ensure patients retain health care access when the crisis is over.