The FDA today issued its first emergency use authorization for a molecular COVID-19 diagnostic test for at-home use without a prescription. The Cue Health COVID-19 Test for Home and Over The Counter (OTC) use is a molecular nucleic acid amplification test designed to detect genetic material from the SARS-CoV-2 virus in the nostrils. The authorized […]
Diagnostics
Abbott wins EUA for COVID-19, flu, RSV combo assay
Abbott (NYSE:ABT) announced today that it received FDA emergency use authorization (EUA) for its Alinity m Resp-4-Plex molecular assay. The laboratory PCR diagnostic is designed to detect and differentiate between SARS-CoV-2 (the virus causing COVID-19), influenza A, influenza B and respiratory syncytial virus (RSV) in one test. It already has CE Mark approval and is […]
Hillrom execs change their minds on BardyDx acquisition
Hillrom (NYSE:HRC) says closing conditions have not been met when it comes to the company’s previously planned $375 million acquisition of Bardy Diagnostics and its Carnation Ambulatory Monitor, or CAM patch. In response, BardyDx has sued Hillrom in the Delaware Court of Chancery, asking the court to order the merger to proceed because Hillrom’s argument […]
Abbott COVID-19 serology test gains EUA
Abbott (NYSE:ABT) this week received FDA emergency use authorization (EUA) for its AdviseDx SARS-CoV-2 IgG II diagnostic — providing another tool to detect people’s adaptive immune response to COVID-19. The serology test from Abbott Park, Ill.-based Abbott is indicated for the qualitative and semi-quantitative detection of IgG antibodies to SARS-CoV-2 — the virus causing COVID-19 […]
Boston Scientific completes Preventice buy, divests BTG Pharmaceutical business
Boston Scientific (NYSE:BSX) announced that it completed its acquisition of Preventice Solutions that could be worth up to $1.225 billion. The transaction includes a cash payment of $925 million upfront with up to an additional $300 million in potential commercial milestone payments available. Accounting for the company’s approximately 22% equity stake in Preventice prior to the […]
Quidel wins FDA nod for at-home antigen test
The FDA issued an emergency use authorization today for the Quidel Corp. (NSDW:QDEL) QuickVue At-Home COVID-19 test, another antigen test to rapidly collect and test samples at home, without the need to send a sample to a laboratory for analysis. The QuickVue At-Home COVID-19 test is authorized for prescription home use with self-collected nasal swab […]
Eurofins launches direct-to-consumer home COVID-19 PCR test
Eurofins (Paris:ERF.PA) announced today that it received FDA emergency use authorization (EUA) for its direct-to-consumer COVID-19 test. Luxembourg-based Eurofins’ EmpowerDX at-home COVID-19 nasal PCR test collection kit can be sold directly to consumers without a prescription to aid in testing for SARS-CoV-2, the virus causing COVID-19, according to a news release. Currently, the kit is available […]
Hologic acquires molecular diagnostic company for $159M
Hologic today announced that it acquired molecular diagnostic company Diagenode for $159 million. Through the deal, Hologic will pay $159 million, subject to working capital and other customary closing adjustments. European Diagenode develops molecular diagnostic assays and epigenetic products. It has more than 30 real-time PCR tests that are CE-marked to detect bacteria, parasites and […]
The top 7 medtech CEO quotes on COVID-19, one year later
The latest earnings season has provided insights into the future of medtech in the COVID-19 landscape and what certain sectors are seeing as vaccines start to roll out. Since the start of the pandemic, 113.1 million COVID-19 cases have been reported worldwide, according to Johns Hopkins University School of Medicine. The U.S. leads the world […]
Forest Devices touts study of stroke detection tech
Forest Devices this week touted study results for its AlphaStroke technology for identifying patients with large vessel occlusive (LVO) strokes. Pittsburgh-based Forest Devices, one of MassDevice’s 2020 medical device startups you need to know, designed the AlphaStroke platform to detect stroke and LVO, offering first responders the ability to use the system to triage patients […]
iRhythm’s revenue jumps 33% in Q4
iRhythm Technologies (NASDAQ: IRTC) reported mixed Q4 results but predicted strong sales growth in 2021. The San Francisco–based company — maker of the Zio ambulatory cardiac monitoring patch — reported a loss of –$9.7 million, or –33¢ per share, on sales of $78.8 million for the three months ended Dec. 31, 2020, nearly halving its […]
