FDA warning letters to device makers have been conspicuous in their paucity in recent years, but they have been surfacing with greater frequency over the past few months.
The FDA has awarded a breakthrough device designation to a polymer film implant to create an artificial endothelial layer in the eye. Known as Endoart, it is designed to replace a non-functioning endothelium, which is the single layer of cells on the inner surface of the cornea. Without it, excess fluid flows into the cornea and can result in severe vision loss.
Aria CV Inc., which focuses on pulmonary arterial hypertension (PAH), has won a breakthrough device designation from the U.S. FDA for the Aria CV pulmonary hypertension (PH) system. The implanted Aria CV PH system aims to restore the benefits of a healthy, elastic pulmonary artery, which in turn reduces cardiac workload and enhances blood flow.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Advantage Choice Care, Cardinal Health, Ethicon, Tele Medcare.
Now that U.S. Health and Human Services (HHS) Secretary Alex Azar has declared a nationwide public health emergency due to the 2019 novel coronavirus (2019-nCoV), HHS is saying it may need more money to help it be as proactive and aggressive as possible in detecting the virus and containing an outbreak.
HONG KONG – Over the weekend, India’s Union Finance Minister Nirmala Sitharaman has imposed a health cess (also known as tax on tax) of 5% on the imports of medical equipment, except those exempted from basic customs duty (BCD). The aim of this development, stated in Sitharaman’s 2020 budget address, is to give impetus to the domestic industry and to generate resources for health services in the country.
LONDON – Brexit finally becomes a reality at midnight central European time on Jan. 31, but for the life sciences industry uncertainty continues, as the U.K. enters an 11-month transition phase during which the terms of its future relationship with the EU must be negotiated.
Medtronic plc has gained CE mark approval for its Cobalt and Crome portfolio, the company’s first implantable cardiac defibrillators (ICDs) and cardiac resynchronization therapy-defibrillators (CRT-Ds) to offer connected health via Bluesync technology. The portfolio will be rolled out on a country-by-country basis throughout Europe, with initial implants in select countries to begin soon.
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