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Brian Bossetta on Muck Rack

Brian Bossetta

Verified
New York
As seen in: Citeline, Medtech Insight, The New York Times, Times Union (Albany), 27east, HBW Insight, In Vivo, The Pink Sheet, Chain Drug Review, Friends of Cancer Research, Mass Market Retailers
Covers:  Medical devices, health care, government regulation and policy.

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Brian Bossetta’s Biography

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Brian Bossetta is a native of New Orleans, a die-hard Saints fan, a lover of classical music, jazz and scotch. He resides in New York's magnificent Hudson Valley with his wife, Caroline.

Brian Bossetta’s Journalist Portfolio

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A Trillion On The Table. Addressing Disparities In Women's Health Isn't Just Right. It's Smart.

A Trillion On The Table. Addressing Disparities In Women's Health Isn't Just Right. It's Smart.

Advocates spanning the spectrum of women's health met in Manhattan to discuss the gender disparities that rem…

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DeepLook AI Imaging Provides A Deeper Look At Dense Breast

DeepLook AI Imaging Provides A Deeper Look At Dense Breast

DeepLook Medical recently announced the commercial rollout of DL Precise, an AI-powered imaging platform that…

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Disparities - Including Financial Shortcomings - Remain In Women's Health, Execs Say

Disparities - Including Financial Shortcomings - Remain In Women's Health, Execs Say

FemTech leaders discussed some of the barriers that remain in unlocking the full potential of the women's hea…

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Beyond The Bladder: Incontinence Impacts Mental Health

Beyond The Bladder: Incontinence Impacts Mental Health

In recognition of Mental Health Awareness month, Sarah Jenkins, executive director at the National Associatio…

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Looking Back Towards The Future

Looking Back Towards The Future

As it celebrates 75 years shaping the medtech industry, Medtronic invited Medtech Insight to its Minneapolis …

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'I Owe A Debt Of Gratitude To America,' Says FDA Staffer Whose Termination Was Rescinded

'I Owe A Debt Of Gratitude To America,' Says FDA Staffer Whose Termination Was Rescinded

A lead reviewer at the US FDA's device center is back on the job after being caught up in the purge that hit …

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Articles

CDRH Sets September Meeting To Address AI, Digital Health Regulatory Science Gaps

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By Brian Bossetta Verified
| Medtech Insight Verified
The FDA’s device center will hold a public meeting in September on how regulatory science must evolve to keep pace with advances in medical technology. Discussions will focus on AI and digital health, emerging technologies, and new approaches to evidence generation and testing. (Shutterstock) In May, the Medical Device Amendments of 1976 — the statutory foundation of modern medical device regulation — marked their 50th anniversary.
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Four Serious Injuries Linked to Class I Recall Of Hamilton Medical Ventilator Circuit Sets

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By Brian Bossetta Verified
| Medtech Insight Verified
Hamilton Medical is recalling certain coaxial breathing circuit sets after identifying a valve defect that can cause inadequate ventilation and oxygen desaturation. The Class I recall is associated with four serious injuries but no deaths and follows an early alert the agency posted in June. (Shutterstock) The US Food and Drug Administration has designated a recall of certain coaxial breathing circuit sets from Hamilton Medical as Class I, its most serious recall category.
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GAO Flags Reimbursement Uncertainty And Liability Risk As Wearable Adoption Challenges

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By Brian Bossetta Verified
| Medtech Insight Verified
A GAO report finds wearables can improve clinical care but flags accuracy variability, workflow integration hurdles, and reimbursement uncertainty as barriers to broader adoption — and offers three policy options to address them.
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