Royal Philips (NYSE:PHG) announced today that it received FDA emergency use authorization (EUA) for its IntelliVue patient monitors and active displays. The Amsterdam-based company’s IntelliVue monitors MX750/MX850 and active displays AD75/D85 received authorization to support infection-control protocols and provide caregivers information remotely during the ongoing COVID-19 pandemic. Both sets of IntelliVue products received CE Mark approval […]
FDA
FDA wants to streamline development of at-home COVID-19 diagnostic tests
The FDA announced that it took steps in an effort to support the development of COVID-19 tests for at-home self-collection. Creating a voluntary emergency use authorization (EUA) template outlining the guidelines for at-home sample collection kits is among the steps the agency has taken, according to a news release. The template includes recommendations for laboratories […]
FDA issues EUA for Abiomed Impella RP to treat COVID-19 heart failure
Abiomed (NSDQ:ABMD) announced that it received FDA emergency use authorization (EUA) for its Impella RP for use with COVID-19-related right heart failure. The Impella RP temporary heart pump provides circulatory support for patients with right side ventricular failure. It won FDA approval in September 2017 for such an indication and in October 2019 Abiomed reported real-world data […]
Gynesonics lands FDA clearance for fibroid-removal system
Gynesonics announced that it received FDA 510(k) clearance for its next-generation Sonata System 2.1 for transcervical fibroid ablation (TFA). Redwood City, Calif.-based Gynesonics’ Sonata platform integrates what the company touts as the first and only intrauterine ultrasound system with a proprietary advanced radiofrequency ablation device. The system provides an incision-free, uterus-preserving transcervical treatment for symptomatic […]
FDA adds reference panel to study COVID-19 diagnostics
The FDA has released a new reference panel to evaluate diagnostic tests for COVID-19. Reference panels are an additional step to ensure the quality of the tests, validation of new assays, test calibration and monitoring of assay performance, according to the agency. Nucleic acid tests identify infection by confirming the presence of a virus’ genetic […]
Four deaths linked to Medtronic HeartWare recall
FDA has designated a Medtronic (NYSE:MDT) recall of its HeartWare HVAD Pump Outflow Graft and Outflow Graft Strain Relief as Class I — its most serious level. Medtronic, according to FDA, said the outflow graft of the HVAD Pump could tear and the strain relief screw may break during assembly prior to implant, but might not be […]
FDA clears Propeller Health sensor to work with Symbocort inhaler
Propeller Health announced that it received FDA 510(k) clearance for connecting patients using its Symbicort Inhaler to its digital health platform. The Madison, Wis.-based company’s digital health platform already connects to inhalers used by asthma and COPD patients, including ones manufactured by Boehringer Ingelheim, GlaxoSmithKline, Novartis and Orion, along with other generic equivalents. Get the […]
FDA clears United Imaging’s MRI
Medical imaging and radiotherapy outfit United Imaging announced today that it received FDA clearance for its UMR Omega MRI scanner. Shanghai-based United Imaging, which has a U.S. base in Houston, touts the UMR Omega as having the world’s first ultra-wide 75 cm bore to provide a patient-centric experience for accomodating wide range of patients, according […]
Philips wins 510(k) for sensor to detect COVID-19 patient deterioration
Royal Philips (NYSE:PHG) announced that it has won FDA 510(k) clearance for a wearable biosensor to help manage confirmed and suspected COVID-19 patients in the hospital. The Amsterdam-based company described the BX100 biosensor as a wireless wearable sensor designed to help healthcare providers detect when COVID-19 patients in lower-acuity units are at risk for deterioration so […]
Steris wins second EUA to decontaminate up to 30m respirators per day
Steris (NYSE:STE) has won an FDA emergency use authorization (EUA) for a new steam sterilization method to decontaminate used N95 respirators. The EUA covers the new Steris Steam Decon cycle to decontaminate 3M 1860, 3M 1860S, and 3M 1804 NIOSH-approved N95 respirators that are or might be contaminated with SARS-CoV-2 and other pathogenic microorganisms. The FDA […]
FDA signals PPE shortage, issues EUA for more
The FDA has issued a call for manufacturers to produce more non-surgical gowns and other personal protective equipment (PPE) as the coronavirus pandemic makes its way across the country. The emergency use authorization issued Friday also listed conductive shoes and shoe covers, operating room shoes and shoe covers, surgical helmets and caps and other surgical […]