Welldoc announced today that it received FDA clearance for an additional feature of its BlueStar Rx software for users of long-acting insulin. Patients with diabetes who are prescribed the insulin adjustment program (IAP) as part of BlueStar can now receive real-time adjustments to their insulin with the newly cleared feature, according to a news release. […]
FDA
Battelle under fire for decontamination system performance
Major media outlets are questioning the ability of the Battelle Critical Care Decontamination System (CCDS) to safely reprocess used N95 respirators up to 20 times, as the company has claimed. The FDA granted the nonprofit tech development company an emergency use authorization in March for its vaporized hydrogen peroxide system to decontaminate N95 respirators used […]
FDA says lay rescuers can use Zoll AED 3 defibrillator
Zoll Medical announced yesterday that its Zoll AED 3 defibrillator received FDA premarket approval (PMA) for use by lay rescuers. Chelmsford, Mass.-based Zoll’s AED 3 defibrillator uses CPR technology with integrated, real-time feedback to deliver guideline-compliant CPR to improve outcomes from sudden cardiac arrest. The company touts its enhanced technology as the first in the […]
FDA approves remote to check out Axonics neuromod device before MRI
Axonics Modulation Technologies (NSDQ:AXNX) announced today that it received FDA pre-market approval for its SmartMRI wireless patient remote control. Irvine, Calif.-based Axonics’ wireless control for SmartMRI is used with its implantable r-SNM (sacral neuromodulation) systems that treat urinary and bowel dysfunction. The new control allows for a simplified full-body MRI process by offering a technician a […]
FDA streamlines at-home COVID-19 test applications
The FDA has added a method to streamline COVID-19 diagnostic test manufacturers’ efforts to apply for an emergency use authorization (EUA) for home sample collection. The new template on the FDA website includes recommendations for laboratories and commercial manufacturers to use in preparing and submitting an EUA request. Currently, developers can offer a COVID-19 test […]
3NT Medical lands FDA clearance for Colibri endoscopy system
3NT Medical announced that it received FDA 510(k) clearance for its Colibri micro ENT single-use endoscope used for otology. In a news release, the Short Hills, N.J.-based company touted the Colibri scope as the world’s first single-use endoscope specifically designed for otology. It features a lightweight, ergonomic handpiece, a 2.2mm diameter tip and a built-in […]
Philips wins EUA for acute-care patient monitoring
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 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 […]