Lucira Health announced today that it received FDA emergency use authorization (EUA) for over-the-counter sales of its COVID-19 test kit. Emeryville, Calif.-based Lucira’s PCR molecular test kit, the Lucira Check It kit, is designed to deliver results in 30 minutes or less at home. The authorization covers those with symptoms and those without, and the […]
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AI-aided colon cancer tech gets FDA nod
Cosmo Pharmaceuticals announced today that it received marketing authorization for its GI Genius AI-based lesion detecting system. GI Genius is an intelligent endoscopy system that uses AI/machine learning to detect lesions in the colon such as polyps or suspected tumors in real-time during a colonoscopy, according to a news release. The device, which received FDA […]
MedTech 100 roundup: Industry roars back
In the blink of an eye, the medtech industry exited its spring slump and neared its all-time best performance levels. MassDevice‘s MedTech 100 Index offered signs of a rebound last week and has built on that momentum, registering a final tally of 109.39 points on April 9. That represents a 2.9% increase from the 106.26-point mark […]
DTW Podcast: Herrera on how military lessons led to Medtech career; Ulmer ready to redo landmark FDA survey
In this week’s podcast, Derek Herrera explains how a serious battle injury he received while leading Marines in Afghanistan led him to build a career in medtech. Herrera has founded two companies – Spinal Singularity and Habit Camera – to create devices that can improve and save the lives of people who need help the […]
EMA begins investigation of J&J COVID-19 vaccine’s blood clotting potential
The European Medicines Agency (EMA) announced that it is beginning a review of blood clots appearing in a handful of recipients of the Johnson & Johnson COVID-19 vaccine. EMA recently concluded that blood clots associated with low blood platelet levels were a “very rare” side effect of Vaxzevria, the vaccine from AstraZeneca. Four recipients of […]
Medtronic stent graft recall is serious
The FDA has deemed the recall of the Medtronic (NYSE:MDT) Valiant Navion thoracic stent graft system as Class I, the most serious kind. Medtronic’s Valiant Navion is designed to repair lesions of the descending thoracic aorta, using a long catheter to place the stent graft inside the aorta before it expands to fit within the aorta to […]
Olympus opens new U.S. medical business HQ in Massachusetts
Olympus announced that it opened a new global headquarters in Westborough, Mass. for its therapeutic solutions division. The facility, announced yesterday, is also the new U.S. headquarters for the Tokyo-based company’s medical business Olympus said in a news release that it identified its therapeutic solutions division (TSD) as a strategic focus for growth, shifting its […]
FDA clears Activ Surgical hardware for enhanced surgical visualization
Activ Surgical announced today that it’s won FDA 510(k) clearance for ActivSight, the company’s intraoperative imaging module for enhanced surgical visualization. Todd Usen, the Boston-based company’s CEO, described the clearance as “big news” in a LinkedIn post. “This clearance gets us one step closer to bringing our technology to ORs around the world and enabling […]
FDA tells hospitals: Stop reusing disposable masks
The FDA issued guidance today recommending that healthcare personnel and facilities cease the reuse of disposable masks. According to the recommendations, healthcare personnel and facilities should transition away from crisis capacity strategies like decontaminating or bioburden reducing disposable respirators for reuse. The CDC’s National Institute for Occupational Safety & Health (NIOSH) approved an increased domestic […]
Outset Medical to raise nearly $366M from primary, upsized offerings
Outset Medical (NSDQ:OM) announced today that it priced an underwritten public offering of shares of its common stock. San Jose, Calif.–based Outset — maker of the Tablo hemodialysis system — is offering 2.5 million shares of common stock sold by the company itself, plus more than 3.4 million shares of its common stock sold by […]
Are Black patients not getting LVADs as quickly as white patients?
Researchers from the University of Missouri conducted a study that found disparities in treating Black and white patients with advanced heart failure. According to a news release, the study found that Black patients with advanced heart failure were more likely to receive a left ventricular assist device (LVAD) — a pump implanted into the chest […]