Hologic notified the state of Connecticut that it plans to cut 86 jobs at its Danbury, Connecticut facility. CTInsider first reported the layoffs yesterday, Oct. 21. The women’s health and diagnostics company sent a letter notifying Connecticut’s Labor Dept., dated Oct. 18, 2024. Layoffs at Hologic may raise eyebrows after CFO Karleen Oberton gave an […]
Genomics/Molecular Diagnostics
FDA revokes EUA for Cue Health COVID-19 tests
The FDA today issued a notice classifying the recall of Cue Health COVID-19 tests as Class II and revoking the tests’ EUA. Earlier this year, the FDA said an inspection found that the company made changes to tests that previously garnered emergency use authorization (EUA) in 2020 and 2021. Cue Health also won FDA de novo clearance for its […]
The top 10 women’s health stories of the year so far
It has been a blockbuster year for women’s health as the federal government and medtech place particular focus on the wellbeing of women. At the start of the year, President Joe Biden announced the federal government would focus its health initiatives on improving women’s health outcomes. Since then, his administration has announced two other federal […]
BD has a new Life Sciences president
BD announced today that it appointed Michael Feld as its new EVP and president of Life Sciences. Feld’s appointment goes into effect on Aug. 20, 2024, as he also joins the Franklin Lakes, New Jersey–based company’s executive leadership team. He succeeds Dave Hickey, who retired from BD last month. Hickey initially announced his plan to […]
FDA authorizes Watmind USA’s OTC COVID and flu test
Watmind USA announced that the FDA granted it emergency use authorization (EUA) for its SpeedySwab COVID + flu A&B self test. EUA covers over-the-counter (OTC) and point-of-care (POC) use. The Jackson, Mississippi-based company developed the test in partnership with the NIH’s Rapid Acceleration of Diagnostics (RADx) Independent Test Assessment Program (ITAP). Watmind USA aims to […]
Cue Health lays off remaining employees after FDA warning on COVID-19 tests
Cue Health (NASDAQ: HLTH) is laying off all of its remaining employees in the U.S. — including the company’s leadership — after the FDA warned that the device developer’s COVID-19 tests should not be used. As of May 1, San Diego-based Cue Health already told 191 employees they would lose their jobs in July. The […]
FDA warns not to use Cue Health COVID-19 test kits
The FDA has warned that home test users, caregivers and healthcare providers should not use Cue Health COVID-19 diagnostics. This warning extends to COVID-19 tests for home and over-the-counter (OTC) use as well as a test intended for patient care settings. According to the FDA, it issued the warning as a result of an increased […]
European Commission says Illumina can move forward with Grail divestiture
Illumina (Nasdaq:ILMN) announced today that it received approval of its plan to divest Grail from the European Commission (EC). In September 2020, Illumina announced an agreement to acquire Grail, a DNA sequencing and array-based tech developer. Grail itself was a startup that initially spun out from the company in 2016. Illumina completed the acquisition in August […]
Illumina CFO departs, replacement named along with chief strategy officer
Illumina (Nasdaq:ILMN) announced that it appointed Ankur Dhingra as CFO following the departure of Joydeep Goswami. The company also announced the appointment of Jakob Wedel as chief strategy and corporate development officer. Its c-suite continues to undergo a makeover following the appointment of a new CEO last year amid its long-running battle to acquire Grail. Goswami, […]
Hologic to shutter some facilities within diagnostics unit
Hologic plans to close certain international facilities amid product discontinuations and restructuring within its diagnostics business. The company outlined the changes — first reported by MedTech Dive — in its quarterly Form 10-Q filed with the SEC, dated Feb. 2, 2024. Hologic reported accelerated depreciation of $7.2 million and a lease asset impairment charge totaling […]
Siemens Healthineers to close Fast Track Diagnostics unit
Siemens Healthineers announced today that it intends to close its Fast Track Diagnostics Unit in a move that affects just shy of 100 workers. The business closure affects about 90 employees, mostly based in Luxembourg. The company has conversations underway with local employee representatives and plans to follow local labor regulations and guidelines in accordance […]
