Brain-Mapping Device US FDA-Cleared To Help Surgeons Better Visualize Surgical Area

The neurosurgical planning software is meant to help surgeons see critical parts of the brain to prevent causing unnecessary harm to patients undergoing brain surgery.

A brain wrapped with a simple road map texture

Omniscient Neurotechnology’s Quicktome device has been cleared in the US to help surgeons map a patient’s brain before operating on them. The neurosurgical planning software is meant to help reduce surgical uncertainty and prevent surgeons from cutting into critical areas of the brain that could harm the patient.

The company announced on 21 July that it received 510(k) clearance for the Quicktome device from the Food and Drug...

More from Business

Boston Scientific Raises Outlook … Again: Headwinds Offset By EP And Watchman

 

Agent drug coated balloon, Watchman product sales, and electrophysiology (EP) business unit growth offset Acurate discontinuation and tariff headwinds. CEO Michael Mahoney shouted out coronary therapies business and answered questions on CMS proposed Ambulatory Surgical Center codes.

FDA ‘Regulatory Accelerator’ Aims To Speed Digital Health Development

 
• By 

The US FDA has launched the Regulatory Accelerator to expedite digital health product development. This includes resources like a Resource Index for Innovators, a Medical Device Software Guidance Navigator, and best practices for early meetings.

Medtech M&A Resurges: How To Define Startup Exit Strategy

 

The medtech M&A landscape is experiencing a resurgence fueled by significant capital from private equity and venture firms, says Alex Wakefield, CRO of AcuityMD. Building strong relationships with physicians remains crucial in medtech, and defining an exit strategy early is imperative.

Intuitive Surgical Sees Early Wins With Da Vinci 5, Lifts FY25 Guidance As Tariff Impact Eases

 
• By 

For the full year, the company now expects tariffs to increase the cost of sales by approximately 1% of revenue, plus or minus 20 basis points. This is lower than the previous estimate of approximately 1.7% of revenue. The updated gross margin guidance for 2025 is 66%-67%, up from 65%-66.5%.

More from Medtech Insight

Time For Medtech To Have Its Say On Critical Changes In EU Framework Legislation

 

In revising the foundations of EU product legislation, the European Commission aims to increase harmonization, cut regulatory burdens and promote digital tools to boost compliance and safety.

Medtech M&A Resurges: How To Define Startup Exit Strategy

 

The medtech M&A landscape is experiencing a resurgence fueled by significant capital from private equity and venture firms, says Alex Wakefield, CRO of AcuityMD. Building strong relationships with physicians remains crucial in medtech, and defining an exit strategy early is imperative.

Intuitive Surgical Sees Early Wins With Da Vinci 5, Lifts FY25 Guidance As Tariff Impact Eases

 
• By 

For the full year, the company now expects tariffs to increase the cost of sales by approximately 1% of revenue, plus or minus 20 basis points. This is lower than the previous estimate of approximately 1.7% of revenue. The updated gross margin guidance for 2025 is 66%-67%, up from 65%-66.5%.