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Medrobotics' Flex Robot Gets US FDA All-Clear For New Indications

 
• By Reed Miller

The Flex system, originally cleared in 2015 for transoral applications, is now available for robot-assisted visualization in general surgical, gynecological and thoracic procedures.

Medrobotics Corp.'s Flex robotic imaging system is now US FDA-cleared for transabdominal and transthoracic access for general surgical, gynecological and thoracic procedures.

Medrobotics says the new 510(k) clearance, announced on Jan. 22, makes Flex the "world’s first and only flexible transabdominal and...

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More from Gynecology and Urology

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

 
• By Brian Bossetta

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

 
• By Brian Bossetta, Marion Webb, Elizabeth Orr, and Natasha Barrow

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

 
• By Marion Webb, Brian Bossetta, Elizabeth Orr, and Natasha Barrow

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

 
• By Elizabeth Orr

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

More from Device Area

Philips Deals Itself A Strong Hand In POCUS Stakes

 
• By Ashley Yeo

Point of care ultrasound technology that can be used by non-sonographers will plug gaps in workforce coverage and bring new critical care capabilities to the frontline of care, said Royal Philips.

Liquid Biopsy Startup Mursla Bio Launches AI Precision Medicine Platform

 
• By Natasha Barrow

The new AI Precision Medicine platform supports the company’s flagship product, EvoLiver, which received US FDA breakthrough device designation in April.

Harbinger Health Showcases Two-Tiered MCED Test With Strong Specificity And Per-Cancer Accuracy

 
• By Shubham Singh

With a test platform designed to mirror the biological diversity of cancer, Harbinger Health is moving beyond traditional performance measures to introduce cancer-specific sensitivity and “intrinsic accuracy” as cornerstones of its clinical narrative.