Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Axonics, Quotient, Saluda Medical, Sense.
New legislation providing a tax incentive for Australian medical innovations was introduced in Australia’s House of Representatives, and industry stakeholders are lauding the move. The measure, providing a special tax regime on income derived from patents, a “patent box,” will apply for income years beginning on or after July 1.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Artventive Medical, Biobot Surgical, Mawi DNA Technologies.
China’s NMPA has given 10 of Sihuan Pharmaceutical Holdings Group Ltd.’s skin repair products medical device registration certificates. The products are developed by its medical aesthetics platform, Beijing Meiyan Kongjian Biology Medicine Co. Ltd.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Circa Scientific, KSL Diagnostics, SQI Diagnostics.
Vena Medical Inc. received Health Canada approval for a device that combines two neurovascular catheters that typically work separately to remove clots from the brains of people who have suffered stroke.
The FDA continues its tight surveillance of rapid antigen tests for the COVID-19 pandemic and has issued three safety communications advising against the use of these tests thus far in the month of March. In each instance, the test is made by the manufacturer of name, but was not authorized in the U.S., making these misbranded products despite their legal use in other nations.
The U.S. FDA does not have legal authority to impose recalls on most regulated products, making the March 3 final guidance for voluntary recalls a key policy declaration for industry. The guidance recommends that recalling firms make extensive use of electronic communication to announce a recall, but the referenced FDA guidance for electronic communications was finalized in 2006 and makes no reference to social media as an electronic conduit for recall information.
LONDON – The European Commission (EC) has put forward proposals for a Data Act that is intended to both give users greater rights over their own data and allow greater third-party access. The Act sets out who can use and access data generated in the EU across all sectors of the economy. It is pitched by the EC as opening the doors to an under-used resource that will in turn promote research and innovation and create new markets in information services.