Mayo Clinic announced that it has developed a test to detect the SARS-CoV-2 virus that causes COVID-19. The individuals undergoing the Mayo Clinic test could receive their results within 24 hours, according to Mayo Clinic’s clinical virology laboratory director Matthew Binnicker. That compares with the several days to a week patients have been waiting for […]
FDA
Roche secures emergency use authorization for coronavirus test
Roche (SWX: RO, ROG) announced today that its Cobas SARS-CoV-2 test is the first commercially distributed diagnostic test to receive an FDA emergency use authorization during the coronavirus pandemic. The tests are also now available in countries accepting the EU’s CE Mark. FDA didn’t object to Roche pre-positioning its test, so labs are now able to initiate testing […]
FDA asks manufacturers to help prevent protective gear shortages
The FDA said today it wants to hear from surgical mask and gown manufacturers that might be able to increase or speed production to prevent shortages in the U.S. during the COVID-19 outbreak. The agency said it may expedite review of manufacturing site changes or premarket submissions of personal protective equipment, including protective clothing, gowns, […]
FDA clears Fluidda’s high-res respiratory imaging software
Fluidda (Los Angeles) said today that the FDA has cleared its Broncholab software designed to to assist in diagnosing and monitoring of respiratory diseases for clinical use. The Broncholab platform can provide a number of functional respiratory imaging (FRI) parameters to physicians via an online platform, according to the company. FRI combines high-resolution computed tomography, […]
Medtronic recall of HeartWare HVAD system battery charger is Class I
The FDA has labeled a Medtronic (NYSE:MDT) HeartWare HVAD system battery charger as Class I — it’s most serious level. A notice out March 9 from the FDA said that the Fridley, Minn.-based medtech giant recalled 5,489 total battery charger devices due to the potential for an HVAD system user to mistakenly insert the charger’s AC […]
Medtech sterilization business faces battles on many fronts
As the EPA prepares to issue new regulations for the carcinogenic sterilant gas ethylene oxide, the industry must decide whether to invest in expensive emissions-control upgrades, switch sterilization processes or — in the case of some small sterilization companies — exit the business. Nancy Crotti, Managing Editor In the next few months, the U.S. Environmental […]
BREAKING: FDA postponing all foreign inspections amid coronavirus outbreak
The U.S. FDA said today that it is postponing foreign inspections through April as the coronavirus outbreak continues to worsen around the world. The agency already halted medical device plant inspections in China, where the virus originated. Dr. Stephen Hahn, the FDA’s commissioner, said in a statement that the agency came to its latest decision […]
NeuroPace wins FDA approval of MRI labeling for its neurostim system
NeuroPace announced today that FDA approval of MRI labeling for its RNS system for people living with seizures that do not respond to medication. The Mountain View, Calif.–based company touts its RNS system as the world’s only closed-loop brain-responsive neurostimulation system designed to prevent seizures at their source. It includes a neurostimulator, leads placed at […]
Pavmed to resubmit carpal tunnel device 510(k) application
Pavmed (NSDQ:PAVM) said today that it has reapplied for FDA 510(k) clearance for its CarpX device designed to treat carpal tunnel syndrome. In August 2018, the FDA group reviewing the application for CarpX requested that the company resubmit the application because the group hadn’t reached a consensus within the designated review period. The resubmission incorporates data […]
BD recalls hundreds of thousands of Alaris pumps due to multiple issues
The FDA today warned on a Class I recall of Becton Dickinson (NYSE:BDX) Alaris system infusion pumps due to multiple system errors, software errors, and use-related errors. All lots of five different models of the Alaris system were included in the recall that Becton Dickinson initiated on Feb. 4. In total, the company recalled 774,000 devices […]
FDA seeks comment on next round of user fees
The FDA has scheduled a public meeting for April 7 to discuss the the medical device user fee program that will be in place from 2022 to 2026. The current Medical Device User Fee Amendment (MDUFA IV) expires Sept. 30, 2022. Before Congress can reauthorize the amendment, the FDA must consult with the regulated industry […]