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Clinical Trials

A Design History File (DHF) is a crucial component of medical device development.

A Design History File (DHF) is a crucial component of medical device development.

Building a Design History File (DHF): Key Documentation for FDA Compliance

A Design History File (DHF) is a crucial component of medical device development.

Madeleine DeSpirito

Apr 13, 20252 min read

A doctor in a white coat, with a stethoscope draped around their neck, types on a laptop, highlighting the integration of technology into medical practice.

A doctor in a white coat, with a stethoscope draped around their neck, types on a laptop, highlighting the integration of technology into medical practice.

Top Preclinical Tests Needed for Medical Device Approval: What to Know Before You Begin

Medical devices must undergo extensive testing before being developed and approved to guarantee patient safety and efficacy.

Madeleine DeSpirito

Apr 6, 20254 min read

Boston Scientific and analysts have already hyped the early success of the company’s Farapulse PFA system.

Boston Scientific and analysts have already hyped the early success of the company’s Farapulse PFA system.

Boston Scientific’s Farapulse matches Medtronic cryoablation in trial

Atrial tachyarrhythmia recurred in 39 patients treated with Boston Scientific’s Farapulse PFA device,.

Madeleine DeSpirito

Apr 2, 20252 min read

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