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medical device regulation

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Representative image of a medical aesthetics consultation, reflecting Aphranel MagiCCrystal CaHA Filler’s EU MDR certification and the growing role of regenerative injectable treatments in Europe’s premium dermal filler market.
Medical Devices & Diagnostics

Why Aphranel’s EU MDR approval could sharpen competition in CaHA dermal fillers

Aphranel’s CaHA filler has secured EU MDR certification. Find out what this means for regenerative aesthetics and Europe’s filler market.

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Cornerstone Robotics wins CE Mark for Sentire as Europe’s surgical robotics race heats up
Medical Devices & Diagnostics

Why Cornerstone Robotics’ Sentire CE Mark could shake up Europe’s surgical robotics market

Cornerstone Robotics has cleared Europe’s MDR bar for Sentire. The real test is whether surgical robotics can scale beyond elite hospitals.

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FDA De Novo decision on LifeVac could reshape the regulatory future of anti choking airway clearance devices
Medical Devices & Diagnostics

Could LifeVac redefine emergency choking response after failed basic life support protocols

FDA grants De Novo clearance to LifeVac as the first authorized anti choking device. Discover what this means for emergency airway care and medical device regulation.

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Hand and wrist heat therapy devices still face a credibility gap and InventHelp’s mitten illustrates why
Medical Devices & Diagnostics

What InventHelp’s heat therapy mitten reveals about the limits of consumer pain devices

InventHelp’s heat therapy mitten targets hand pain, but what does it really change? Explore the evidence, regulatory gaps, and limits of consumer pain devices.

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