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Gynecology & Urology

LSI 2025: Intuitive Surgical CEO Gary Guthart On da Vinci 5’s Force Feedback, Digital Coaching, ION Expansion, And Robotic Surgery’s Future

Medtech Insight sat down with Intuitive Surgical CEO Gary Guthart at the recent LSI USA conference to discuss the full launch of the new da Vinci 5 robotic system and planned digital enhancements. Guthart also offered his views on health care interoperability, AI regulation, outpatient surgeries, autonomous robots, and how the company is harnessing technology to shape the future of robotic surgery.

New EU Filings Include First-Of-Its-Kind MS Drug Tolebrutinib & HIV Prophylaxis Lenacapavir

Several new drugs that are yet to be approved anywhere in the world are now under review by the European Medicines Agency for potential pan-EU marketing authorization.

Boston Scientific’s Head Of Urology Says Axonics Acquisition ‘Brings A More Comprehensive Gender Balance’

Medtech Insight spoke with Meghan Scanlon, president of Boston Scientific’s urology division, about integration plans for the recently acquired Axonics medtech. The purchase adds sacral neuromodulation to Boston Scientific’s portfolio, a global market that research reports valued at $1.6bn in 2023.

Biden Proposes Requiring Private Insurance To Pay For OTC Birth Control As Elections Approach

Biden’s order for proposed rules could boost support for Democrat Kamla Harris from undecided voters concerned about reproductive rights or for Republican Donald Trump from those who agree with his conservative stance on access to birth control, which he argues should be up to states to regulate. Proposed rules also could stir consumers not planning to vote to go to the polls.

FDA Publishes Updated Roadmap For Advancing Women’s Health

The US FDA’s Office of Women’s Health provides a research roadmap to address health concerns specific to women. The FDA recently updated the roadmap, outlining areas in which further research is needed.

FDA Publishes Updated ‘Roadmap’ For Advancing Women’s Health

The US FDA’s Office of Women’s Health provides a research roadmap to address health concerns specific to women. The FDA recently updated the roadmap, outlining areas in which further research is needed.

News We’re Watching: New FDA Approvals For Breast Implant, Colon Cancer Test, Imaging Agent; TAP Expansion, AI Standards

This week, Establishment Labs Holdings announced the FDA gave it premarket approval for Motiva breast implant, Cologuard lands FDA approval for Cologuard Plus and GE HealthCare gets FDA nod for a new imaging agent. The FDA announces another expansion for TAP into ophthalmology and radiology. The AAMI and CTA will join forces to develop standards for AI and ML-enabled health care products.  

News We’re Watching: Neuralink’s Blindsight Gets FDA Breakthrough Device Tag; FDA Pump Recalls, Guidances; Discure, DeepLook Bolster Coffers

This week, Neuralink announced it received US FDA breakthrough device designation for a device to restore sight; medtechs Discure and DeepLook secured new funding; FDA pump recalls from B. Braun Medical and Fresenius Kabi; Axonics prevails in patent infringement lawsuit with Medtronic; Merit Medical buys Cook Medical for $210m.

Prodded By Congress, FDA Launches Tampon Review

The US agency said on 10 September that it plans to study whether heavy metals detected in tampons could endanger their users.

US FDA Advisors Want Iterum’s Antibiotic Indication Narrowed

The agency’s Antimicrobial Drugs Advisory Committee suggested a more limited indication for Interum’s antibiotic for uncomplicated urinary tract infections than the sponsor proposed, though it wasn’t necessarily clear committee members favored approval.