Hormonal

Biolinq Aims To Transform Diabetic Glucose Monitoring With Needle-Free Patch

 
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Biolinq’s CEO Rich Yang spoke to Medtech Insight about the company’s wearable patch in development, which uses tiny microsensors to measure, for now, glucose, with ample runway for additional indications down the line. If approved by the US FDA, the device would become the first of its kind to monitor glucose levels in diabetes patients not using insulin.

Amber Therapeutics Secures $100M To Develop Neuromodulation For Mixed Urinary Incontinence

 
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UK-based Amber Therapeutics said it raised $100m in a series A financing round led by New Enterprise Associates. It plans to use the proceeds to fund the development of Amber-UI through pilot and pivotal studies aiming US regulatory approval.

Women’s Health Innovation: What Are We Waiting For?

An investigator, an investor and an inventor walk into the New York Stock Exchange, and it’s no joke. Women’s health is a fruitful investment with a clear path to financial return. 

Corcept’s Coup De GRACE

 

The follow-on Cushing’s product relacorilant has hit in Phase III, and is forecast to lead the market – eventually.    

US FDA May User Fee Preview: Vaccines, Gene Therapy, And Double Oncologics

 

Five novel agents are among the user fee goal dates coming up in May 2024.

Maxwellia Delivers Two UK Menstrual Health Rx-To-OTC Switches

 
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UK switch specialist Maxwellia delivers two “me too” reclassifications in the area of women's health: Evana Heavy Period Relief and Ultravana Period Pain Relief. 

Puberty Blockers: FDA's Califf Asked If REMS, Boxed Warning Against Off-Label Use In The Works

 
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FDA Commissioner Robert Califf tells House appropriations subcommittee chair the agency will 'consider any information that may be available' on off-label use of puberty blockers for gender dysphoria before making a regulatory decision.

Menopause Research To Benefit From White House Initiative To Bolster Women’s Health

 
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Women’s health leaders in the menopause space have high hopes that President Biden’s executive order will provide dollars for more research on how hormone therapy can prevent disease and draw attention to the need for provider education on menopausal symptoms.

As A Young Woman Marissa Fayer ‘Fell’ Into Medtech. Now, As An Industry Leader, She’s Focused On Leveling The Field

 

Marissa Fayer is dedicated to advancing women’s health. The founder and CEO of HERhealthEQ, a global nonprofit focused on women’s health equity in emerging and developing countries, Fayer is also the CEO of DeepLook Medical. As part of our focus on women’s health in honor of Women’s History Month, Fayer spoke to Medtech Insight about the importance of having more women in all sectors of medtech, both for the benefit of industry as well as women patients.

Birth Control Guidance For Insurers Aims To Boost Coverage, Smooth Exemption ‘Pathway’

 
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Three-agency guidance, issued as Biden administration is hoping to emphasize reproductive rights in its reelection campaign, outlines the narrow set of circumstances in which a health plan doesn’t have to fully cover certain types of birth control.

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