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 […]
U.K. court bars Edwards TMVR sales, gives Abbott win in patent spat
A judge in the England issued an injunction yesterday barring Edwards Lifesciences from selling its Pascal transcatheter mitral valve repair (TMVR) device in the U.K. A different judge had previously denied Abbott’s petition for such an injunction. Yesterday, Judge Colin Birss of the High Court of England and Wales also ruled that two patents held […]
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, […]
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, […]
B. Braun sued in Pa. over ethylene oxide exposure
A Pennsylvania man has filed a lawsuit against B. Braun Medical over emissions of the sterilant gas ethylene oxide (EtO). The man, Adam Akarsoy, lives and works near a B. Braun sterilization plant in Hanover, Pa., and filed the federal lawsuit seeking certification as a class action. Akarsoy claims that B. Braun “has consistently emitted, on average, nearly […]
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 […]
Cutera claims Lutronic stole trade secrets
Medical aesthetic devicemaker Cutera (NSDQ:CUTR) has filed a lawsuit claiming that Lutronic Aesthetics stole trade secrets, lured away employees and competed unfairly under California’s business and professions code. Brisbane, Calif.-based Cutera is also suing certain former employees, alleging violations of their work agreements as well as violations of duties owed to the company under California […]
Dianosic lands CE Mark for intranasal bleeding device
Startup Dianosic (Strasbourg, France) announced today that it has obtained the CE Mark for CAVI-T, a low-pressure asymmetric balloon for treating spontaneous and post-operative intranasal bleeding. CAVI-T is the first asymmetric intranasal balloon that stops bleeding by applying low-force compression while adapting to the anatomy of the nasal fossa, according to the company. The balloon […]
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 […]