Nevro Corp.’s stock was up following encouraging results detailed during its fourth-quarter earnings call. Management predicted a positive 2020, highlighting the potential of the U.S. spinal cord stimulation (SCS) market. Keith Grossman, chair, CEO and president of the company, noted that the SCS market slowed last year as a result of stocking issues – a challenge that affected both it and its competitors.
The U.S. FDA has given its nod to Novalung, a heart and lung support system from Fresenius Medical Care North America (FMCNA) for the treatment of acute respiratory or cardiopulmonary failure. The Waltham, Mass.-based company noted that Novalung is the first extracorporeal membrane oxygenation (ECMO) system to be cleared for more than six hours of use.
Keeping you up to date on recent developments in cardiology, including: Using AI to predict heart attacks, stroke; Startup focuses on nano-capsules derived from milk to deliver heart drug; Biotronik sees positive results with ultrathin strut DES.
Asuragen Inc., an Austin, Texas-based molecular diagnostics company, has received good news from the U.S. FDA. The agency gave the green light for the company’s Amplidex Fragile X Dx and Carrier Screen Kit, which aims to detect a genetic condition known as Fragile X syndrome. The diagnostic kit determines the number of cytosine-guanine-guanine (CGG) repeats in the FMR1 gene to aid in the diagnosis of Fragile X syndrome and associated disorders, including Fragile X-associated tremor/ataxia syndrome and Fragile X-associated primary ovarian insufficiency.
Redwood City, Calif.-based Q Bio Inc., which is offering a quantitative assessment of personal health, has come out of stealth mode, scooping up $40 million in a series B funding round led by Andreessen Horowitz. The funds are earmarked to improve its proprietary platform and technology to make its preventive health services faster, better and more affordable for all.
Trisalus Life Sciences Inc., of Westminster, Colo., reported the start of a clinical trial assessing a treatment that combines its intravascular, tumor-directed proprietary Pressure-Enabled Drug Delivery (PEDD) approach with standard-of-care systemic chemotherapy.
The results from a study comparing San Diego-based Bionano Genomics Inc.’s Saphyr to traditional cytogenetic methods for the clinical analysis of leukemia genomes revealed that the system was 100% concordant with the standard of care for the detection of somatic chromosomal abnormalities.
Ferrum Health Inc., of San Francisco, is looking to prevent medical errors with the help of artificial intelligence (AI). That caught the eye of Sutter Health, a not-for-profit health care network in Northern California. To that end, the two have unveiled the debut of Ferrum's AI-powered platform as the system to deliver more consistent care to patients.
Alydia Health Inc., of Menlo Park, Calif., has completed enrollment in the pivotal PEARLE investigational device exemption (IDE) study, which is assessing the safety and effectiveness of the Jada system to rapidly control and treat abnormal postpartum uterine bleeding and postpartum hemorrhage.
Guilford, Conn.-based Hyperfine Research Inc. has received the U.S. FDA’s nod for a bedside magnetic resonance imaging (MRI) system and is eyeing this summer for shipments. The portable system can be wheeled directly to the patient’s bedside and plugs into a standard electrical wall outlet.