Medtech layoffs are picking up as 2024 draws to a close. Sean Whooley, Associate Editor, and Chris Newmarker, Editor-in-Chief The medical device industry is closing out the year with a fresh round of layoffs. At this point, MassDevice has reported on more than 22,000 medtech job cuts across the industry since mid-2022. (Have a tip […]
Cue Health
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 […]
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 […]
Cue Health wins FDA de novo authorization for home COVID-19 test
Cue Health (Nasdaq:HLTH) announced that it received FDA de novo authorization for its Cue COVID-19 molecular test. San Diego-based Cue Health designed the test for both home and point-of-care use. Its authorization marks the first such nod for a home-use COVID-19 test, the company said. It also represents the first de novo authorization for any […]
Cala Health, Cue Health have layoffs in California
Cala Health and Cue Health (Nasdaq:HLTH) both recently filed with the state of California to confirm reductions in their workforces. The two companies are the latest to join the long list of medtech companies cutting employees amid a challenging time for the industry. To date, MassDevice has reported on more than 18,000 medtech employees who have been […]
Cue Health submits RSV molecular test to FDA for de novo clearance
Cue Health (Nasdaq:HLTH) announced today that it made a de novo submission to the FDA for clearance of its RSV molecular test. The submission aims to garner full clearance of the test for at-home and point-of-care use. According to Cue Health, no respiratory syncytial virus (RSV) tests exist on the market for home use. Pending […]
Cue Health, Major League Baseball partner on COVID-19 testing
Cue Health (Nasdaq:HLTH) and Major League Baseball (MLB) announced today that will expand on league-wide COVID-19 testing. Under a national partnership, Cue Health — MLB’s trusted at-home testing solution — will provide MLB clubs as well as the league office with its integrated care platform that includes the portable and reusable Cue Health monitoring system […]
Cue Health launches direct-to-consumer virtual health platform
Cue Health (NSDQ:HLTH) announced today that it will launch its direct-to-consumer virtual health program on Nov. 15, 2021. San Diego-based Cue Health’s virtual health platform includes what it says is a first-of-its kind molecular COVID-19 test through its new eCommerce site and in-app shop. The company said in a news release that it makes the […]
MedTech 100 roundup: More growth ahead?
A turgid month for the medtech industry might be drifting into the past after the past week indicated a slight turnaround as summer nears. MassDevice‘s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished the week at 107.74 points, marking a 1.4% rise from the 106.22-point mark set one […]
Cue Health raises $235M to support its over-the-counter, home-use diagnostics
Healthcare technology company Cue Health announced that it closed a private financing round worth $235 million. Existing investors Johnson & Johnson Innovation — JJDC, Decheng Capital, CAVU Ventures, ACME Capital and more contributed to the financing, as did new investors Perceptive Advisors, MSD Capital and Koch Strategic Platforms, according to a news release. Morgan Stanley […]
