Keeping you up to date on recent developments in diagnostics, including: Speeding triage of COVID-19 patients; New tests distinguishes COVID-19 and flu; Predicting heart failure; Expanding cryptosporidiosis testing in developing regions.
The U.S. FDA has granted breakthrough device designation to Spark Biomedical Inc. for its Roo system, a transcutaneous electrical nerve stimulator to assist newborns with opioid withdrawal. The noninvasive neurostimulation device is modeled on the company’s Sparrow Therapy System for adult opioid withdrawal relief.
Edwards Lifesciences Corp. held its 2020 virtual investor conference Dec. 10, providing details on its 2021 financial outlook. The company is projecting global mid-teen sales growth totaling $4.9 billion to $5.3 billion and a return to double-digit sales growth in its transcatheter aortic valve replacement (TAVR) business. Earnings per share (EPS) guidance for the coming year is $2-2.20, below the consensus estimate of $2.21, due to investments in R&D and sales to fuel future growth.
The U.S. FDA has made it easier for people who want to get tested for COVID-19, granting emergency use authorization (EUA) for direct-to-consumer sales of Laboratory Corp. of America Holdings’ (Labcorp) Pixel COVID-19 test home collection kit. With this latest EUA, any individual 18 years and older can purchase the Pixel test system without a prescription.
Keeping you up to date on recent developments in diagnostics, including: Predicting breast cancer recurrence, Comparing SARS-CoV-2 PCR tests, Paying attention to the little guy in proteomics, Increasing biomarker reproducibility
A percutaneous hydrogel treatment for chronic low back pain has won a U.S. FDA breakthrough device designation. The status will enhance interactions between Baltimore, Md.-based Regeltec Inc. and the agency during regulatory review of the Hydrafil implant, accelerating the path to clinical trials and commercialization.
Critically ill infants in need of continuous renal replacement therapy (CRRT) are often treated using machines intended for adults, leading to a number of challenges and a high risk of complications and death. Now, Medtronic plc has launched a pediatric and neonatal acute dialysis machine in the U.S. that is specifically designed for patients weighing between 2.5 and 10 kilograms. The Carpediem Cardio-Renal Pediatric Dialysis Emergency Machine, the first of its kind in the U.S., received U.S. FDA clearance in April via the de novo pathway and is classified as a class II device.
Artificial intelligence (AI)-powered cell capture startup Deepcell Inc. scooped up $20 million in a series A round led by Bow Capital. The funds are earmarked for developing the company’s microfluidics-based technology, building out a cell morphology atlas of more than 400 million cells and advancing a hypothesis-free approach to cell classification and sorting.
The Cooper Companies Inc. (Coopercompanies) again beat analyst estimates, posting fiscal fourth-quarter revenue of $682 million – down 3% from the same period the prior year, but ahead of the Street’s forecast of $676 million. Earnings per share (EPS) also topped consensus, at $3.16 vs. $3.09. The company attributed the better-than-expected performance to encouraging recovery trends in both its contact lens and surgical businesses.
COVID-19 has shined a spotlight on the vast potential of digital health, from pandemic response to how clinicians protect and care for patients. Now, Israel-based venture capital firm OTV has closed a $170 million fund aimed at fueling future growth in digital health technologies. In conjunction with the closing, OTV also reported that it has changed its name from Olive Tree Ventures and named Jose Antonio Urrutia Rivas as head of Asia Pacific operations.
