MEDdesign

Voice Technology Is Here and Will Change Healthcare

By Sloan Gaon, PulsePoint

The explosion of this technology is changing patient interaction with physicians, hospitals, and the entire healthcare landscape in general.

Another Cash Deal:
J&J’s Ethicon to Acquire Auris Health for $3.4 Billion

By MedTech Intelligence Staff

The deal will help J&J speed up its entry into the robotics market.

FDA Issues Guidance on 510(k) Exemption of Certain Low-Risk Devices

By MedTech Intelligence Staff

The agency’s intent is to decrease regulatory burden while promoting patient access to products.

EU MDR: Breathe Easy on Clinical Evaluation Reports

By Scott Edwards, Maetrics

The first critical step in being able to feel confident about your clinical evaluation reports (CERs) is to ensure you know exactly what they entail.

Featured Quote

With recent updates to ISO 10993-1 and the Medical Device Regulation (MDR) on track to replace Europe’s current Medical Device Directive in 2020, medical device manufacturers are scrambling to navigate the changes and develop their pre-clinical device testing strategies. Understand, this isn’t just a regulatory challenge, it’s a business challenge.

— Susan Schaible,
WuXi AppTec

Children Are Not Small Adults
Kids Need Pediatric Devices

By Giselle C. Matlis, Axendia, Inc.

Most devices are still developed in a moment of need and not in advance like adult devices.

Edwards Lifesciences Acquiring CAS Medical Systems for $100 Million
in Cash

By MedTech Intelligence Staff

The deal will help strengthen the Edwards portfolio of smart monitoring technologies.

FDA Encourages Innovation and Safety as Part of Medical Device Regulatory Overhaul

By Amy Scanlin,
EAS Consulting Group, LLC

The agency is increasing its focus on risk reduction and increased oversight while also promoting innovation.

5 Things Everyone
Needs to Know About
Micro Molding

With the pressure on design engineers to deliver smaller, lighter, and more cost-effective components many are turning to micro injection molding for support. Challenges often arise when designing for micro molding that can present unforeseen road blocks. Questions like - What is micro molding? How is it different from standard molding? – are commonly asked by engineers. This whitepaper will explore the answers to these and other pertinent questions.

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• Medical Recall