Boston Scientific (NYSE:BSX) announced today that CMS will speed up Medicare beneficiaries’ access to single-use endoscopes, including Boston Sci’s Exalt Model D single-use duodenoscope. The Centers for Medicare & Medicaid Services (CMS) granted a Boston Sci application for a plication for a transitional pass-through (TPT) payment category — an only months-old payment category meant to provide […]
Diagnostics
Phosphorus wins FDA EUA for at-home COVID-19 saliva test
Phosphorus today announced it received FDA emergency use authorization for its COVID-19 saliva test for at-home sample collection. The test is the second at-home unsupervised saliva test approved by the FDA so far, according to the company. It is available by ordering online and is available through healthcare and employer partnerships. Saliva tests are simple […]
Sherlock Biosciences announces manufacturing partnership for CRISPR-based COVID-19 test
Sherlock Biosciences announced today that it will collaborate with Integrated DNA Technologies (IDT) to enable large-scale manufacturing of the Sherlock CRISPR SARS-CoV-2 kit for COVID-19 detection. Officials at Cambridge, Mass.–based Sherlock Biosciences think the company’s CRISPR-based diagnostic test, which recently received an FDA emergency use authorization, will increase testing capacity and decreasing time to result […]
FDA warns of cyanide gas danger with improper use of Hologic COVID-19 tests
The FDA warned laboratories today that using certain transport media for COVID-19 samples with Hologic (NSDQ:HOLX) Panther and Panther Fusion diagnostic systems can produce deadly cyanide gas. Transport media is the liquid that maintains a specimen sample while it is transported to a laboratory. The Hologic Panther systems and others that have been sterilized using bleach […]
Clew Medical gains EUA for predictive screening software for COVID-19
Clew Medical recently received FDA emergency use authorization for its ClewICU System for use in intensive care units. The EUA covers the company’s ClewICUServer and ClewICUnitor. The system is a standalone software that is designated as a medical device. It uses commonly recorded vital signs, nursing assessments, flowsheet data, medications and lab data to compute […]
FDA streamlines at-home COVID-19 test applications
The FDA has added a method to streamline COVID-19 diagnostic test manufacturers’ efforts to apply for an emergency use authorization (EUA) for home sample collection. The new template on the FDA website includes recommendations for laboratories and commercial manufacturers to use in preparing and submitting an EUA request. Currently, developers can offer a COVID-19 test […]
FDA wants to streamline development of at-home COVID-19 diagnostic tests
The FDA announced that it took steps in an effort to support the development of COVID-19 tests for at-home self-collection. Creating a voluntary emergency use authorization (EUA) template outlining the guidelines for at-home sample collection kits is among the steps the agency has taken, according to a news release. The template includes recommendations for laboratories […]
Digirad closes $5m offering
Digirad (NSDQ:DRAD) announced that it closed an underwritten public offering of common stock with proceeds expected to reach approximately $5 million. The offering includes more than 2.2 million shares of common stock and warrants to purchase up to more than 1.1 million shares. Each share of common stock is sold together with one common warrant […]
Siemens Healthineers secures EUA for its COVID-19 antibody test
Siemens Healthineers (ETR: SHL) announced today that it has secured an FDA emergency use authorization for its COVID-19 antibody test. The news comes nearly a week after the German medtech giant said it had started worldwide shipments of the test — a laboratory-based total antibody test that can detect SARS-CoV-2 antibodies including IgM and IgG in blood. […]
FDA adds reference panel to study COVID-19 diagnostics
The FDA has released a new reference panel to evaluate diagnostic tests for COVID-19. Reference panels are an additional step to ensure the quality of the tests, validation of new assays, test calibration and monitoring of assay performance, according to the agency. Nucleic acid tests identify infection by confirming the presence of a virus’ genetic […]
Acutus Medical, Biotronik ink deal
Acutus Medical and Biotronik have announced that they will collaborate on electrophysiology, mapping, ablation and accessory products across certain markets. The products involved in the collaboration center around the treatment of cardiac arrhythmias in markets that include Europe and Asia, according to a news release. The partnership centers on Acutus’ AcQMap system, which Acutus touts […]