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With Roe v. Wade In Rearview, What’s Next For Women’s Health?

 
• By Elizabeth Orr

Manufacturers of devices and apps focused on reproductive health are still feeling out the import of a recent US Supreme Court decision overturning the federal right to abortion. Some attorneys say the ramifications may be vast.

Pro-choice demonstrators gather in front of the US Supreme Court to protest the Dobbs v. Jackson decision on 24 June 2022.
Pro-choice protestors gather in front of the US Supreme Court in Washington, DC, on 24 June. • Source: Shutterstock

The US Supreme Court’s ruling in Dobbs v. Jackson Women's Health Organization last week, which overturned abortion-rights bedrock case Roe v. Wade, left many stakeholders asking what comes next. That’s true of women, of health care providers, of lawmakers – and of medical technology companies whose devices may be pulled into the fray.

“There’s a couple of implications here,” said Bethany Corbin, an attorney with Nixon Gwilt Law who specializes in technology related to women’s health, or “femtech.” “The majority opinion expressly stated that it was limiting this overturning of privacy rights to abortion

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State And International Enforcement Agencies May Step Up Amid Uncertain Federal Environment

 
• By Elizabeth Orr

States and international regulatory bodies may increase their US enforcement role following federal staff cuts, Hyman Phelps & McNamara attorneys said in a recent webinar. The attorneys also expect False Claims Act enforcement and public health to remain key areas of focus at the federal level.

FDA And Boston Scientific Face Legal Action Over Spinal Device Safety

 
• By Elizabeth Orr

A patient, Dena Lawler, is suing Boston Scientific and the US FDA over alleged harm from a spinal stimulator device. Lawler claims inadequate regulatory review allowed dangerous modifications to the device, which then caused her pain and other health issues. She is calling for reconsideration of the device approvals.

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• By Brian Bossetta

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US Medtech Tariffs: How Will EU Navigate Unchartered Territory?

 
• By Amanda Maxwell

US President Trump has imposed sweeping tariffs that encompass medtech. These are expected to drive up costs, disrupt supply chains and hinder innovation, likely driving the EU to seek new trade partnerships to mitigate the impact.

More from Policy & Regulation

SS Innovations Files For De Novo For SSi Mantra 3 Surgical Robotic System For Multispecialty Indications

 
• By Marion Webb

SS Innovations announced plans to file a de novo application with the US FDA for its SSi Mantra 3 surgical robot, already approved for marketing in six countries. The Florida-based firm also plans to pursue the CE mark for European commercialization.

Faster Device Certification Among Keys To Unlocking Innovation In EU MedTech Sector

 
• By Amanda Maxwell

While MedTech Europe sharpens its focus on what the EU most urgently needs to advance the medtech market in four targeted measures, the European Commission has also unveiled four priorities for 2025.

Beyond The Bladder: Incontinence Impacts Mental Health

 
• By Brian Bossetta

In recognition of Mental Health Awareness month, Sarah Jenkins, executive director at the National Association for Continence, discussed the mental health issues that often come with incontinence.