FDA Archives - Page 101 of 103 - Medical Design Sourcing

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 uterine fibroids.

According to a news release, the next-generation version of the system incorporates additional features to improve usability and streamline workflow. New features include a new treatment device design and a smaller, more ergonomic radio-frequency ablation handpiece with improved controls.

Dr. Ladina Christoffel of Spital Oberengadin — Schweiz (Samedan, Switzerland), who has performed procedures using Sonata 2.1 since last month, said in the release that improvements to the controls in the new versi…

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 material (RNA), and the FDA said its new reference panel provides developers access to this material.

The agency described it as an independent performance validation step for diagnostic tests of SARS-CoV-2 infection that are being used for clinical, not research, purposes. It is available to commercial and laboratory developers who are interacting with the FDA through the pre-emergency use authorization (EUA) process.

“The FDA has taken many steps during this pandemic to ensure that Americans have access to trustworthy diagnostic tests,” said Jeffrey Shuren, director of the FDA’s Center for Devi…

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 full story at our sister site, Drug Discovery & Development.

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 to a news release.

UMR Omega also has a 680-lb table capacity and is designed to — for the first time, according to the company — create an MRI for bariatric patients.

The scanner can be used with pediatric and geriatric patients with faster scanning for patients who are unable to stay still for long periods of time. It also offers acute imaging in the emergency room, five-minute stroke protocol and cardiac imaging with a single breath-hold that reduces the number of required scans.

According to United Imaging, the U.S. is the first country in the world to welcome UMR Omega to its commerci…

Philips wins 510(k) for sensor to detect COVID-19 patient deterioration

(Image from Philips)

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 they can intervene.

The lightweight, disposable biosensor is a 5-day, single-use wearable patch can be integrated with a scalable hub to monitor multiple patients across different rooms, according to Philips. It is designed to adhere discreetly to the chest to collect, store, measure and transmit respiratory rate and heart rate every minute — the top two predictors of deterioration — as well as contextual parameters such as posture, activity level and ambulation. The sensor is built to work with existing …

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 authorized the cycle for use on Steris’ Amsco medium-heat sterilizers, which the agency previously cleared.

The Dublin, Ireland-based company estimated that the new method could decontaminate more than 30 million respirators per day if all of its compatible U.S.-based sterilizers are fully employed.

Compatible N95 respirators will be individually pouched using sterilization pouches that are FDA-cleared for steam sterilization. They may be decontaminated by this process up to 10 times and be reusable only by the original users, according to the EUA.

This is the second EUA for Steris t…

FDA signals PPE shortage, issues EUA for more

This map by GetUsPPE shows where shortages of personal protective equipment are most acute in the U.S.

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 accessories.

The FDA said it issued the EUA in response to concerns about shortages of gowns and other apparel for use by healthcare personnel. Earlier this month, the agency said that healthcare organizations had informed the agency that some distributors may be allocating PPE basing on a health system’s previous use rather than its projected use.

Shortages of PPE prompted a recent article in The Lancet, based on a study by GetUsPP…

FDA eases regs on certain device changes during pandemic

The FDA will allow limited changes to certain devices so medtech companies can address manufacturing and supply chain issues due to COVID-19-related disruptions.

In a guidance released yesterday, the agency said it would allow changes to devices approved through its premarket approval (PMA) and humanitarian device exemption (HDE) pathways as long as those changes do not create an undue risk. The new guidance will remain in effect for the duration of the COVID-19 public health emergency.

Get the full story on our sister site, Medical Design & Outsourcing.

15 heart devices that could boost their manufacturers’ sales

(Image from Cardiovalve)

Before the coronavirus pandemic hit, medtech companies large and small were making notable news with a number of innovative heart devices.

Some of these same companies took a big hit to their bottom lines when the danger of spreading COVID-19 and using up precious personal protective equipment convinced hospitals to limit non-urgent procedures.

Now hospitals are looking at ways to safely return to business-as-usual — they and the medical device industry as a whole hope to improve their balance sheets. For example, Medtronic (NYSE:MDT) CEO Geoff Martha and CFO Karen Parkhill expressed optimism in an analyst call today that their company’s businesses already are showing signs of a rebound in the month of May.

Get the full story on our sister site, Medical Design & Outsourcing.

Abbott: ID NOW COVID-19 results more accurate with earlier testing

Abbott’s ID Now test machine (Image from Abbott)

Abbott (NYSE:ABT) said today that its ID NOW COVID-19 test works better on specimens collected soon after patients begin showing symptoms.

The test’s performance has drawn fire from federal officials in recent weeks, including a recent FDA warning that the ID NOW test may return false-negative results. The agency granted the test an emergency use authorization (EUA) on March 27 and said it is now investigating whether false-negative results could be due to the types of swabs used or the type of viral transport media.

Abbott began advising customers in mid-April that ID NOW is a rapid test that was not designed for use with viral transport media. The company also recommended using dry nasal swabs to collect samples.

Today, the company announced an interim analysis of an ongoing clinical study at five urgent care clinics in New Jerse…

FDA launches COVID-19 research initiative

The FDA has entered an agreement with healthcare analytics company Aetion to research urgent questions about COVID-19.

The New York City-based company said the research will support FDA objectives to explore the natural history of the disease, as well as treatment and diagnostic patterns using relevant, novel data sources and analyzing these data according to well-established principles.

“The FDA is approaching the generation of real-world evidence for COVID-19 with a sense of urgency to learn what we can, as soon as we can, from patients who are receiving care right now,” said FDA principal deputy commissioner Amy Abernethy in a news release. “We also recognize that COVID-19 is a dynamic situation. We can use current data and learn what decisions we can confidently make now, and we can learn what we’ll need to do in the future as more data become available.”

Aetion and the FDA will identify and analyze fit-for-purpose data sources to characterize COVID-…

This patient-mover got an emergency COVID-19 nod from the FDA

The Patient Isolation Transportation Unit (PITU) [Image courtesy of AR Tech, a division of A&R Tarpaulins]

AR Tech, a division of A&R Tarpaulins, announced today that the FDA has granted an EUA for its Patient Isolation Transportation Unit (PITU) to help hospitals better manage the COVID-19 pandemic.

“PITU is a game-changer in this fight against the pandemic because it is a negative pressure isolation enclosure that makes working with highly contagious diseases a safer process,” said Carmen Weisbart, a registered nurse who is president of A&R Tarpaulins.

“PITU also allows properly attired family members to see patients who are infected with COVID-19,” Weisbart said in a news release.

Dr. Mark Comunale, head of anesthesiology at Arrowhead Medical Center (Colton, Calif.), developed the unit in 2015 with the Ebola outbreak in mind. AR Tech (Fontana, Calif.) joined his efforts two yea…