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. Read More

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. Read More

San Diego-based Illumina Inc. is synonymous with next-generation sequencing (NGS) equipment. But when it comes to dealmaking, the genomics giant is focused largely on software to make its results more useful, accessible and affordable. It has acquired cloud-based software startup Bluebee Holding BV in its latest move on this front. Read More

LONDON – Sirakoss Ltd. has received FDA 510(k) clearance for its nanoparticle synthetic bone graft substitute, after showing the ready-to-use putty is equivalent to the CE-approved dry formulation. Rather than granules that are mixed with a patient’s blood before administration, the inorganic calcium phosphate-based Osteo³ Zp putty consists of the granules suspended in a fully synthetic resorbable carrier. Read More

HONG KONG – Singapore-based Igene Laboratory, a wholly owned subsidiary of Inex Innovate Pte. Ltd., has launched a noninvasive prenatal test (NIPT) that assesses fetal Rhesus factor (RhD) status from a maternal blood sample. Read More

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. Read More

New hires and promotions in the med-tech industry, including: Carestream Health, Change Healthcare, Medx Health. Read More

Med-tech firms raising money in public or private financings, including: Cardiovascular Systems, Caredx, Cryolife, Oncology Venture, Orthopediatrics, Repro Med Systems. Read More

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Livongo. Read More

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. Read More

Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aethlon, Icotec, Naviswiss, Pear Therapeutics, Sirakoss. Read More

The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Antibodiescheck.com, Medakit, Sonrisa Family Dental. Read More

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. Read More