Apple Sets the Stage for FDA Regulation on Two Types of AFib Mobile Medical Apps

USA – Apple Sets the Stage for FDA Regulation on Two Types of AFib...

The US Food and Drug Administration (FDA) granted two de novo classification requests on Tuesday on applications to be used with the Apple Watch...
FDA Looks to Make FOIA Process Easier

USA – FDA Looks to Make FOIA Process Easier

The US Food and Drug Administration (FDA) on Wednesday proposed a new rulemaking that would ease the process by which the public can use...
Health Canada to Amend List of Recognized Standards for Medical Devices

Canada – Health Canada to Amend List of Recognized Standards for Medical Devices

Health Canada is seeking input on proposed changes to the current list of recognized standards for medical devices, including the removal of 20 standards...
Modernizing the Medtech Supply Chain

Study – Modernizing the Medtech Supply Chain

Medical devices move from manufacturer to healthcare practitioner through a complex supply chain that is in serious need of total, end-to-end modernization to improve...
Microfluidic Device Corrals Viable Sperm for IVF

USA – Microfluidic Device Corrals Viable Sperm for IVF

Researchers at Cornell University have developed a microfluidic device to rapidly isolate the strongest and fastest sperm from a sperm sample. The technique should...
Veta Smart Case for Epinephrine Auto Injectors Now Available

Canada – Veta Smart Case for Epinephrine Auto Injectors Now Available

Aterica, a Canadian company, is releasing its Veta smart case for epinephrine auto injectors (think EPIPEN). The device works in conjunction with a paired...
Masimo’s Tiny Breathing Sensor Cleared for Tiny Patients in U.S.

USA – Masimo’s Tiny Breathing Sensor Cleared for Tiny Patients in U.S.

Masimo won FDA clearance for its RAS-45 acoustic respiration sensor, used with the rainbow Acoustic Monitoring (RAM), to be used on infants and neonates. Previously, only...
New Device Vibrates Skull to Diagnose Cause of Dizziness

Europe – New Device Vibrates Skull to Diagnose Cause of Dizziness

Dizziness can be caused by a different underlying health problems, but identifying which is the culprit is not trivial. One technique is called a VEMP...
Versius Robotic Surgical System Unveiled by UK Company

UK – Versius Robotic Surgical System Unveiled by UK Company

CMR Surgical, a Cambridge, UK firm, is formally unveiling its Versius surgical robotic system that is designed to be portable, easy to setup, and,...
Two New Penumbra Catheters to Suck Out Stroke-Causing Clots

USA – Two New Penumbra Catheters to Suck Out Stroke-Causing Clots

Penumbra, a company famous for its suction-based stroke clot removal devices, is releasing what it says is its “most advanced technology,” the Penumbra JET 7...

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