Regulatory Approvals

J&J’s Covid-19 vaccine gets vote of confidence from FDA advisory panel

The committee voted 22-0 on the question of whether the benefits of Johnson & Johnson's Covid-19 vaccine outweigh its risks. FDA emergency use authorization...

Gala Therapeutics Receives FDA Approval to Commence Pivotal Trial to Evaluate the RheOx™ System for Chronic Bronchitis

Gala Therapeutics, Inc. (Gala), a developer of medical devices to treat pulmonary disease, announces U.S. Food and Drug Administration (FDA) conditional Investigational Device Exemption...

Brainlab Loop-X Mobile Imaging Robot and Cirq Robotic Alignment Module for Spine Both Receive FDA clearance

Brainlab announced today that the company has reached two major milestones with the FDA clearance for both Loop-X® Mobile Imaging Robot and Cirq®​​, a robotic...

AI-based voiceprint screener for COVID-19 nets European approval

From taste and smell to muscle aches and “COVID toes,” the coronavirus affects the body in a variety of ways—including small changes in a...

OpSens Obtains CE Marking for the OptoWire III

OpSens Inc. ("OpSens" or the "Company") (TSX: OPS) (OTCQX: OPSSF), a medical device cardiology-focused company commercializing a second-generation fiber optic pressure guidewire to diagnose and treat coronary...

Infant monitoring tech brand Owlet announces SPAC merger for Q2 2021

The company currently sells connected wearables and smart monitors to consumers but said that it will be seeking FDA authorization for new products with...

Stroke treatment device from Israel’s BrainQ wins FDA ‘breakthrough status’

Only about 5% of victims in the US currently arrive at the hospital in time to benefit from currently approved treatments. BrainQ's AI-based device...

FDA greenlights Visby Medical’s single-use, portable PCR test for COVID-19

Visby Medical received a new emergency authorization from the FDA for its rapid, single-use PCR test designed to detect COVID-19 infections at the point...

First Case with HipInsight Augmented Reality for Joint Replacement

Surgical Planning Associates (SPA) today announced a major step forward in how surgery can be performed with the introduction of its HipInsight augmented reality (AR)...
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