The FDA has granted two more companies’ COVID-19 tests emergency use authorizations. Tests by Quest Diagnostics (NYSE:DGX) and Quidel Corp. (NSDW:QDEL) got the nod for distribution within the U.S. without prior clearance or approval. Quest Diagnostics (Secaucus, N.J.) said it will expand testing with its new COVID-19 diagnostic this week from its high-complexity laboratories in Chantilly, Va., […]
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Hologic, LabCorp gain FDA emergency testing nods
The FDA has granted emergency use authorization for COVID-19-related diagnostic tests to Hologic (NSDQ:HOLX) and Laboratory Corporation of America (NYSE:LH). Hologic described its new Panther Fusion SARS-CoV-2 assay as a molecular diagnostic test that detects SARS-CoV-2, the virus that causes COVID-19. The automated Panther high-throughput system is widely used across the U.S., can provide results […]
COVID-19 test development surges with pandemic
Companies around the world are racing to develop and distribute tests for COVID-19 to laboratories and to market other products and services they say can help patients and healthcare providers cope with the pandemic. On March 13, the FDA gave Thermo Fisher Scientific (NYSE:TMO) emergency use authorization (EUA) for a diagnostic test that certain U.S. laboratories […]
Cardinal Health settles China bribery case for $8.8 million
Cardinal Health (NYSE:CAH) has agreed to pay more than $8.8 million to settle charges that a former subsidiary in China failed to detect bribes paid to government hospital officials and employees of state-owned retailers to buy skincare products. The settlement springs from a Securities and Exchange Commission investigation into Cardinal China, which Cardinal Health formed in […]
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, […]
U.S. lifts tariffs on certain medical supplies to prevent spread of coronavirus
U.S. trade officials recently exempted more than 100 medical items manufactured in China from import tariffs in an effort to fight the coronavirus outbreak, according to published reports. Cardinal Health and Medline Industries were among 27 companies with certain products that had their 7.5% tariffs lifted. Exempted products included protective masks, drapes and gowns, hand […]
CHF Solutions secures distribution arrangement in central Europe
CHF Solutions (NSDQ:CHFS) announced today that it initiated distribution agreements with Neucomed Group and its affiliates to cover Germany, Austria and Switzerland. With the new distribution agreements, Eden Prairie, Minn.–based CHF Solutions is further expanding its commercial presence in Europe, as the company now has distribution partnerships covering 13 different countries across the globe, according to […]
Georgia cites BD for warehouse ethylene oxide emissions
Georgia state officials claim that Becton Dickinson (NYSE:BDX) has been operating a medical device warehouse without an air quality permit. The Covington, Ga. warehouse stores devices that have been sterilized using ethylene oxide (EtO), a carcinogenic gas. BD signed a consent order with the Georgia Environmental Protection Divisoin (EPD) in October, agreeing to aerate EtO-sterilized devices for 24 hours […]
CryoLife, Misonix sign distribution deal for NeoPatch
CryoLife this week said it signed a distribution agreement with Misonix where Misonix will have exclusive commercialization rights of NeoPatch. The NeoPatch, made by CryoLife, is a dehydrated and terminally sterilized chorioamniotic allograft that is made from human placental membrane. It is designed to treat a wide range of indications outside of cardiac and vascular […]
Zimmer Biomet, Align Technology ink distribution deal
Zimmer Biomet (NYSE:ZBH) said yesterday that it entered into a multinational distribution deal with Align Technology (NSDQ:ALGN) for its iTero Element family of intraoral scanners. The companies did not disclose the terms of the agreement, but said the partnership has a goal of delivering multiple digital workflows for dental professionals and laboratories, enabling business-to-business collaboration and offering […]
IceCure Medical inks distro deal with Terumo for Japan, Singapore
IceCure Medical said today that it has signed Terumo (OTC:TRUMY;TYO:4543) as the exclusive distributor of its tumor-freezing technology in Japan and Singapore. Terumo will pay IceCure $2 million for the distro rights if IceCure obtains the appropriate regulatory approvals for its ProSense cryoablation device, designed to treat malignant breast tumors without surgery. This will include […]