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Tag: fda

510k Vs Premarket Approval

510k Vs PMA we know that both the requirements are necessary of FDA device regulaltion. The difference between the two is that Class...

Able Medical Announces FDA 510K Clearance for the MACH™ Screw Clip System

Able Medical Devices announces that the MACH™ Screw Clip System has been granted 510k clearance by the FDA. PlatoAi. Web3 Reimagined. Data Intelligence...

What will happen with CMS’ policy to cover breakthrough medical devices? 

One of many sweeping regulatory changes made in the last year, a rule for CMS to cover breakthrough devices that have been approved...

SpinTech MRI Earns FDA Clearance for Rapid, Quantitative Brain-Imaging Technology

The US Food and Drug Administration (FDA) has approved SpinTech, Inc.'s latest magnetic resonance imaging software device, STAGE (Strategically Acquired Gradient Echo), a...

Newsletter: Quantum encryption + OurCrowd-Azerbaijan MoU

Startup of the Week: QuantLR, low-cost quantum encryption Azerbaijan Investment Co. signs with OurCrowd FDA clears RealView hologram for ‘sci-fi’ surgical planning Nexa3D’s ‘Nexa Level’...

New device can diagnose Covid-19 from saliva samples

Engineers at MIT and Harvard University have designed a small tabletop device that can detect SARS-CoV-2 from a saliva sample in about an...

Abbott gets FDA clearance for CGM app

Abbott received FDA clearance for an app to pair with its Freestyle Libre 2 glucose monitor. The app lets people get readings directly...

FDA Participates in New ‘Collaborative Communities’ to Address Emerging Challenges in Medical Devices

Today, the U.S. Food and Drug Administration announced participation in several new collaborative communities aimed at addressing challenges in patient health care. PlatoAi....

How much does a 510k cost?

How much does a 510k cost is the most common question I receive from customers, and there are three parts to the cost of a 510k. If you want to save $9,559 on your 510k cost of submission to the FDA, you need to listen to ALL of this video and follow every single step […]

The post How much does a 510k cost? appeared first on Medical Device Academy.

Microlearning – A saviour in times of skilling urgency

In today’s era of digitalisation, improving existing skills and developing new ones is an urgent and pressing need, especially when the impact of...

New Psychedelic Anti-Depressant Esketamine: What the Patients Have to Say

Psychedelic-assisted therapy, and the legalization pf psychedelic drugs, is most definitely a thing. We know this, because the psychedelic drug esketamine is already...

[RealView Imaging in Fierce BioTech] FDA clears 3D hologram tech for ‘science-fiction’ surgical planning

The FDA has cleared a system that creates accurate, three-dimensional holograms of a patient’s organs, giving surgeons a new opportunity to interact with...

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