[Editor's note: Complete historical data on global device approvals can be found in Medtech Insight's Approvals Tracker and at MedDeviceTracker].
The US FDA approved one original PMA between April 2 and April 8.
A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. This week, FDA approved TherOx’s Supersaturated Oxygen System. PharmaEngine/Nanobiotix said its Hensify NBTXR3 nano-particles received the CE mark and plans to market it in 27 European countries for treating locally advanced soft tissue sarcoma.
[Editor's note: Complete historical data on global device approvals can be found in Medtech Insight's Approvals Tracker and at MedDeviceTracker].
The US FDA approved one original PMA between April 2 and April 8.
Leaders of robotic systems companies Distalmotion, Neocis and Noah Medical discussed success metrics, competition and funding. Institutional investors are focusing on utilization, procedure rates and a clear path to profitability as the IPO window reopens, BTIG analyst Ryan Zimmerman said.
Dxcover sets up new Clinical Laboratory Improvement Amendments (CLIA) lab in Franklin, Tennessee.
Fallouh Healthcare has received £305,050 in grant funding from Innovate UK as part of the European Union’s Eureka Eurostars program. The company aims to detect cardiac tamponade, a condition that affects patients after heart surgery. Currently, there is no way to accurately diagnose the condition.
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.
Legal experts warn, however, that new Mexican procurement rules are discriminatory and could be challenged in the courts.
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.