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Clinical / R & D

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Clinical Trials

Set Alert for Clinical Trials

US FDA Grants Teal Health’s At-Home Cervical Screening Device Breakthrough Device Designation

Teal Health reached a significant milestone in its mission to bring a prescription-based, at-home, self-collect cervical cancer screening device to market.

Women's Health FDA

Netherlands Pilots New Scientific Advice Service For Clinical Trials

The Netherlands’ Central Committee on Research Involving Human Subjects is gauging sponsor demand for a new scientific advice service for clinical trials, which is for now free of charge.

Netherlands Clinical Trials

Apple Watch Feature Qualified As FDA Device Development Tool

The designation makes the watch's AFib history feature the first digital health tool to be qualified under the US FDA’s Medical Device Development Tools program, meaning it can be used in research during the development of certain cardiac devices.

FDA Regulation

Robotic-Assisted Treatment For Enlarged Prostate Shows Promising Results

A novel robotic-assisted therapy could improve the lives of men with benign prostatic hyperplasia, real-world data presented at the annual meeting of the American Urological Association suggests.

FDA Real-World Evidence
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New Technology

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US FDA Grants Teal Health’s At-Home Cervical Screening Device Breakthrough Device Designation

Teal Health reached a significant milestone in its mission to bring a prescription-based, at-home, self-collect cervical cancer screening device to market.

Women's Health FDA

Robotic-Assisted Treatment For Enlarged Prostate Shows Promising Results

A novel robotic-assisted therapy could improve the lives of men with benign prostatic hyperplasia, real-world data presented at the annual meeting of the American Urological Association suggests.

FDA Real-World Evidence

GE HealthCare’s New Investigational MRI Promises Advancements On Neurological Disease Research

GE HealthCare announced today a new investigational MRI, which will be used in collaboration with researchers at Boston’s Brigham and Women’s Hospital, promises to help researchers better understand complex neurological diseases.

Diagnostic Imaging Neurology

News We’re Watching: Philips Settles Recall Fallout; FDA REdI, Townhalls, Approvals

This week, Philips Respironics reached a $1.1b settlement affecting CPAP and other breathing devices. Toku announced it received US FDA breakthrough device designation for its MyKidneyAI technology. This May, the FDA will hold its REdI conference focusing on innovation in medical product development and hold another townhall focusing on considerations for selecting a sterilization modality.

News We're Watching FDA
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Approvals

Set Alert for Approvals

US FDA Grants Teal Health’s At-Home Cervical Screening Device Breakthrough Device Designation

Teal Health reached a significant milestone in its mission to bring a prescription-based, at-home, self-collect cervical cancer screening device to market.

Women's Health FDA

News We’re Watching: Philips Settles Recall Fallout; FDA REdI, Townhalls, Approvals

This week, Philips Respironics reached a $1.1b settlement affecting CPAP and other breathing devices. Toku announced it received US FDA breakthrough device designation for its MyKidneyAI technology. This May, the FDA will hold its REdI conference focusing on innovation in medical product development and hold another townhall focusing on considerations for selecting a sterilization modality.

News We're Watching FDA

Senseonics Wins Marketing Authorization For Novel Insulin Delivery System

The US FDA has cleared a glucose monitoring system from Senseonics. The authorization of the implantable insulin delivery system creates a new pathway for like devices.

FDA Combination Products

Front Line Medical Technologies Announce CE Mark For COBRA-OS

Front Line Medical Technologies Inc.'s new CE marking expands access of its occlusion device COBRA-OS to medical providers in Europe. Adam Power, chief medical officer at Front Line Medical, talked to Medtech Insight about their marketing plans and benefits of the technology. 

Approvals Europe
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