AdvaMed’s Scott Whitaker and Michael Minogue outlined the trade group’s legislative goals for the rest of the year, chief among them regulatory oversight for lab-developed tests.
Ahead of the 2022 MedTech Conference in Boston, which will be held in person for the first time since before the COVID-19 pandemic, AdvaMed CEO Scott Whitaker and AdvaMed Chair and Abiomed CEO Michael Minogue offered a preview of the trade group’s legislative priorities during a press conference.
AdvaMed’s focus, Whitaker said, is threefold: FDA oversight of lab-developed tests (LDTs), FDA certificates to foreign governments (CFGs), and FDA...
From June 30, new European Commission rules will attempt to redress an imbalance in medtech trade between the EU and the People’s Republic of China.
Flow Neuroscience's neuromodulation headset for the treatment of depression is approved and marketed in the EU. However, two years on, the company is still waiting for US FDA approval despite being assigned breakthrough device designation.
Overlapping clinical testing requirements and decision-making around significant changes to MDAI are among the tricky subjects that the new document explains.
The UK's regulatory agency is the first to join a new international network for oversight of AI in healthcare run by a non-profit organization, HealthAI, the global agency for responsible AI in health.
The US FDA has announced classifications for five device types, including four diagnostics as well as a hand cream to protect healthcare workers exposed to radiation. Two of the products are newborn screening tests.
It’s no secret that Marty Makary and Robert F. Kennedy Jr. have a different take on user fees, with Makary viewing them as a funding necessity and Kennedy as a corrupting influence. But will they find a way to strike a balance during the next MDUFA reauthorization talks so each can claim victory?
Flow Neuroscience's neuromodulation headset for the treatment of depression is approved and marketed in the EU. However, two years on, the company is still waiting for US FDA approval despite being assigned breakthrough device designation.
