New York-based at-home testing startup Letsgetchecked said Friday that the U.S. FDA has granted emergency use authorization (EUA) for its COVID-19 Sure-track Test for signs of active SARS-CoV-2 infection. The polymerase chain reaction (PCR) nasal swab test is for use by at-risk individuals in the home and delivers results within 24 hours of a sample being received by the company’s CLIA-certified laboratory. Read More
The U.S. FDA granted an emergency use authorization (EUA) for Quest Diagnostics Inc.’s self-collection kit for COVID-19. The kit allows individuals to collect their own specimens at home or in a health care setting. Read More
LONDON – Neogenomics Laboratories Inc. is to make a $25 million equity investment in Inivata Ltd. and has taken an option to acquire all of the company as part of a U.S. commercialization agreement with the U.K. liquid biopsy specialist. Under the deal, Neogenomics will take over sales, marketing and billing for Inivata’s Invisionfirst circulating tumor DNA lung cancer test, which is intended to replace tissue biopsies. Read More
The Medicare inpatient draft is always an event due to its impact on medical technology. Now, several products soon may see their new technology add-on payments (NTAP) expire because of eligibility. The Centers for Medicare and Medicaid Services (CMS) said both Claret Medical Inc.’s Sentinel embolic protection device and Procept Biorobotics Corp.’s Aquabeam device have used up their NTAP eligibility, and hospitals may see lower rates for using those devices starting Oct. 1 Read More
PARIS – Carmat SA, which is based in Vélizy Villacoublay, France, reported the first implantation of its bioprosthetic artificial heart at the Heart Center of the Rigshospitalet in Copenhagen, Denmark. Read More
LONDON – A vast new body of genomics research has identified thousands of rare genetic variants that are predicted to cause loss of function in protein coding genes, providing novel in vivo models of human gene inactivation. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Biocept, Caris Life Sciences, Creatv Microtech, Foundation Medicine, Hesperos, Myriad, Personalis, Sengine Precision Medicine, Tiziana Life Sciences. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Astrazeneca, Acupath, Aeec, Eurofins, Genestack, Google Cloud, Ioniq, Labware, Mission Bio, Nano Diagnosix, Orasure, Prolung, Rockland Immunochemicals, SI-Bone, Tangen, Thermo Fisher, Ursure. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Baibies, Letsgetchecked. Read More
Keeping you up to date on recent developments in neurology, including: Vagus nerve research improves stimulation for chronic pain; Restoring nerve-muscle communication in ALS; Biomarkers may help us understand recovery time after concussion; Study: MS risk 29% higher for people living in urban areas. Read More
