Regulatory Approvals

ReWalk lands FDA breakthrough label for home exoskeleton device to restore ankle function after stroke

ReWalk Robotics is picking up the pace on its trek down the FDA's review pathway. The agency has granted ReWalk’s latest offering a breakthrough device...

FDA clears XO Cross microcatheters

Transit Scientific this week announced that it has received FDA clearance for its hydrophilic-coated XO Cross microcatheters for guidewire support, exchange and contrast media...

Vuno’s AI-based ECG analysis software gains breakthrough designation

South Korean artificial intelligence (AI) developer Vuno has announced that the Korean Ministry of Food and Drug Safety (KFDA) has designated the company’s AI-based...

FDA grants breakthrough designation to Magnus’ neurostimulation technology

In a randomised trial, the neurostimulation technology relieved severe depression in 79% of people. The US Food and Drug Administration (FDA) has granted Breakthrough Device...

FDA outlines best practices for healthcare AI, alongside Canada, U.K. regulators

The FDA is joining hands with fellow regulators in Canada and the U.K. to present 10 principles outlining best practices in the development of...

Cheek swab COVID-19 test receives CE mark

Intelligent Fingerprinting’s saliva-based COVID-19 test now carries CE marking. The new VSS-GP COVID-19 Saliva Test uses a swab to collect saliva from just inside the cheek, providing...

Trice Medical nabs first FDA go-ahead for disposable arthroscope with 25-degree view

Though disposable needle arthroscopes have become increasingly popular due to their lower risk of contamination and less invasive profile, full-size reusable arthroscopes are still the...

AI-powered ‘Test-To-Go’ system receives CE mark

Clinical AI company Sensyne Health’s licence and development partner, Excalibur Healthcare Services, has received European regulatory certification, which includes the UK, for its ‘Test-To-Go’ COVID-19...

Luminopia scores FDA De Novo for VR treatment for lazy eye

The tool uses virtual reality to modify media content in order to help children boost their visual acuity. Massachusetts-based Luminopia landed an FDA De Novo...
1...969798...114Page 97 of 114

Latest articles