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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.

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More from Legal & IP

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.

Democrats Condemn Trump’s HHS Layoffs During House Hearing On OTC Drug User Fees

 
• By Malcolm Spicer

Energy and Commerce Health Subcommittee Democrats focus on criticizing HHS Secretary Kennedy’s RIF announcement, including 3,500 FDA jobs among cuts across HHS agencies. Representatives were left wondering if user fee programs would continue, even if reauthorized.

LDT Saga Comes To A Grinding Halt As Judge Sides With Labs, Vacates FDA’s Final Rule

 
• By Brian Bossetta

A federal judge in Texas delivered what is most likely a fatal blow to the US FDA’s final rule, which would have regulated lab-developed tests as medical devices.

US Federal Trade Commission Challenges Surmodics-Biocoat Merger Over Antitrust Concerns

 
• By Elizabeth Orr

A planned merger between medical device coating manufacturers Surmodics and Biocoat is facing an antitrust lawsuit from the US Federal Trade Commission. The FTC believes the move would create an illegal monopoly.

More from Policy & Regulation

Congress, Researchers Highlight Security Risks At DNA Testing Services

 
• By Elizabeth Orr

Congress has launched an inquiry into 23andMe amid privacy concerns following its bankruptcy, particularly regarding the potential sale of sensitive user data. Additionally, a Cybernews report gave 40 DNA testing firms an average cybersecurity grade of D, citing widespread vulnerabilities and data breaches, along with inadequate public information about their security practices.

Notified Bodies Warn Of Hurdles In The Way Of Their AI Designations

 
• By Amanda Maxwell

Will challenges in the way of designations of notified bodies that assess AI-enabled medical devices create delays and bottlenecks and slow EU medtech innovation?

Guidance Feedback Highlights Outstanding Questions In AI Development

 
• By Elizabeth Orr

Many of the hundred-plus commenters to the FDA's draft guidance on AI in medical product regulation said the document was a good start but needed additional clarity and more concrete examples. Stakeholders recommended the inclusion of case studies, metrics, and clearer guidelines to enhance the utility of the guidance, which is seen as a vital step for AI integration in healthcare.