Companies — IVD companies in particular — won't be fooled again by a global pandemic. That's not to say there won't be another global pandemic, of course, but next time companies like Abbott will be well-prepared. Abbott has made sure of this with its newly formed Abbott Pandemic Defense Coalition, a scientific and public health partnership dedicated to the early detection of, and rapid response to, future pandemic threats. Abbott said that by connecting global centers of excellence in laboratory testing, genetic sequencing, and public health research, the program will identify new pathogens, analyze potential risk level, rapidly develop and deploy new diagnostic testing, and assess public health impact in real-time.
Cue Health has been granted emergency use authorization (EUA) for an over-the-counter COVID-19 test. The San Diego, CA-based company’s test is aimed at consumers ages 2, and older – without the need for a prescription. The molecular nucleic acid amplification test is designed to detect genetic material from the SARS-CoV-2 virus. It uses a lower nasal swab and delivers results in about 20 minutes to the user's mobile smart device. The news follows another testing breakthrough as Abbott recently received EUA for a laboratory PCR Assay that detects and differentiates SARS-CoV-2, Flu A, Flu B, and RSV in one test - and FDA EUA for Asymptomatic Usage of Alinity m COVID-19 test.
Ibex Medical Analytics is combining artificial intelligence and cancer diagnostics to improve pathology. The Tel Aviv, Israel-based company raised $38 million in a series B round to accelerate the adoption of the Galen platform, an AI-powered cancer diagnostic solution. This brings the five-year-old company's total fundraising since inception to $52 million.
And in case you missed our last Medtech in a Minute report...
Boston Scientific has agreed to acquire the surgical business of Lumenis for an upfront cash payment of $1.07 billion. Subject to close in the second half of the year, the deal includes Lumenis' energy-based medical solutions (laser systems, fibers and accessories) used in urology and otolaryngology procedures.
Medtronic is recalling the pump implant kit for its HeartWare Ventricular Assist Device after two deaths and many serious injuries were reported. This is the company's second HeartWare-related recall in about a year, and one of several in the device's history. The latest recall is because the device may fail to initially start, restart, or have a delay in restarting after the pump stops, according to a recent FDA MedWatch report.
FDA authorized marketing of a robot-assisted surgical device designed to help facilitate transvaginal hysterectomy in certain patients. Developed by Tel Aviv, Israel-based Memic Innovative Surgery, the Hominis Surgical System is intended for benign hysterectomy (removal of the uterus for non-cancerous conditions) with salpingo-oophorectomy (removal of one or both fallopian tubes and ovaries). Hominis is also the first robot-assisted surgical device with arms designed to replicate the motions and capabilities of a surgeon's arms, with shoulder, elbow, and wrist joints, allowing the surgical robot device to access and reach through areas not possible with other robots.