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. Read More
Lausanne, Switzerland-based Debiotech SA and Neokidney BV, of Amsterdam, have created Nextkidney SA to lead the development and commercialization of Neokidney, a lightweight, plug-and-play, home hemodialysis device. Read More
The U.S. FDA detailed which kinds of SARS-CoV-2 tests are getting top priority, with access to rolling, rapid reviews for emergency use authorization (EUA) during the unfolding pandemic. The agency is aiming to authorize point-of-care and at-home tests to better distribute the use of testing in various locations. It also is looking at automated and high-throughput tests that can offer analysis of larger batches of tests at one time. Read More
In a step toward what may become the new normal, at least for now, the Pediatric Oncology Subcommittee of the FDA’s Oncologic Drugs Advisory Committee is meeting virtually Wednesday and Thursday to review pediatric development plans for four cancer drugs. Read More
TORONTO – What do agricultural pesticides and concealed weapons have to do with med-tech advances in fighting COVID-19? Plenty, according to Canada’s science and industry ministry. Read More
PERTH, Australia – Sydney-based Speedx Pty. Ltd. has signed a global distribution deal with Roche Holding AG, through which the latter will sell Speedx’s Resistanceplus MG and Resistanceplus GC molecular tests for detecting antimicrobial resistance to Mycoplasma genitalium (Mgen) and gonorrhea, respectively. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: BGI, BioIQ, Cigna, DNA Genotek, Illumina, Inspire Medical Systems, Lantheus, Metabolon, Nanostring, Orasure, Ortho, Phosphorous, Progenics, Respira, Sd Biosensor, Truvian, Yuyu Pharma. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Applied Biocode, Cae, Candela, Enexor Health, Foundation Medicine, Tandem Diabetes Care. Read More
Keeping you up to date on recent developments in orthopedics, including: Osteoporosis treatment also may protect against pneumonia; Study finds similar short-term outcomes after common MI spine procedures; New biomaterial has potential to repair damaged bone with lower risk of inflammation; Diabetics face greater risk of bone fractures. Read More
