The workforce reduction trend has swept the economy recently, and unfortunately, the medtech space is not immune to layoffs. You’ve probably read about the ongoing layoffs sweeping the tech industry, media and more. For instance, Yahoo, Disney, Zoom and more all reported workforce reductions as companies across industries grapple with economic pressures. Think inflation, supply […]
Cue Health
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 […]
5 at-home COVID-19 diagnostic tests you should know
The wait for a completely at-home COVID-19 test ended in November when the FDA authorized the first ones that enabled people to obtain samples and results at home. The agency since then has authorized five at-home COVID-19 tests for emergency use since the beginning of the pandemic. The kits are made to take a sample […]
First OTC molecular test for COVID-19 gains FDA nod
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 […]
MedTech 100 roundup: Industry continues its ascent
Stocks in the medtech industry maintained their upward trajectory, topping last week’s peak with yet another rise to new heights. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished last week at 95.66 (Oct. 16), marking a 0.6% gain from the 95.05 points registered at the end of […]
