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Device Debut: Procept Biorobotics Expects To Make A Splash With AquaBeam

 
• By Reed Miller

The clinical trial data that earned the AquaBeam Aquablation system de novo clearance from US FDA in December shows Aquablation is as effective as transurethral resection of the prostate at treating symptoms of benign prostate hyperplasia, but carries a lower risk of complications associated.

Procept biorobotics aqua beam
Procept BioRobotics' AquaBeam System For Treatment Of BPH • Source: Procept BioRobotics Corp.

Procept BioRobotics Corp. is preparing to launch its AquaBeam Aquablation robot-controlled waterjet prostate resection device at the American Urological Association conference in San Francisco in May, touting it as a technology that will "fundamentally transform" the treatment of benign prostate hyperplasia (BPH).

About nine years after the Silicon Valley company was founded to develop the Aquablation technology, US FDA cleared AquaBeam via the de novo pathway on Dec. 21 for the...

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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

Roche Diagnostics Day 2025: ‘We Need To Become A Leader In Decentralized Testing’

 
• By Natasha Barrow

Roche aims to grow its diagnostics sales by mid to high single digits, said CEO of Roche Diagnostics Matt Sause. The company unveiled the Axelios synthesis and sequencing solution and discussed its “long-term commitment” to China, as well as its business strategy for the next five years.

Zika Virus Test Among 4 New FDA Device Classifications

 
• By Elizabeth Orr

The FDA plans to announce class II status for four new device types, including tests for the Zika virus and genetic condition Fragile X. This follows earlier announcements and highlights a trend toward diagnostic classifications. The classifications are considered deregulatory, meaning they will hel

Salvia Bioelectronics Secures $60M In Series B To Advance Chronic Migraine Implant, Eyes US Trials

 
• By Marion Webb

Medtech Insight spoke with Hubert Martens, CEO of Netherlands-based neuromodulation company Salvia Bioelectronics, about the company’s innovative implant for treating chronic migraines, ongoing clinical trials and plans for US clinical trials and commercialization.