Digital Technologies

Medtech Will Benefit From Boost To EU’s Quantum Technology Initiative

 

The European Commission is focusing on how tiny particles behave to help create an EU industrial “powerhouse.”

Bivacor Rotary Heart Could Upend The Artificial Heart Market, If It Reaches Its Destination

 
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Bivacor aims to be first to the US market with a permanent total artificial heart, starting with use as a bridge to transplant. CMO William Cohn says data from countries with low transplant rates could support pivotal trials and long-term use.

Burden Is Too Heavy For Medtechs To Go It Alone On Complex Medtech AI Projects

 

Medtech companies require expertise to navigate complex AI regulations and integrate AI in medical software while addressing regulatory challenges, claims expert AI consultant with medtech experience.

Ochsner Surgeon In ‘The Big Easy’ Eases Patient’s Pain With Skill And Virtual Reality

 

A surgeon at Ochsner Health in New Orleans was able to successfully remove a rare and dangerous tumor from a patient’s spine using cutting-edge technology that would have otherwise made the procedure too risky.


HealthAI: ‘Established Regulations Already Exist For Regulating AI In Healthcare Safely’

 

Paul Campbell, chief regulatory officer at HealthAI, emphasizes existing regulations for AI in healthcare should not be overlooked as new regulations are developed.

From Imitation To Action: Johns Hopkins Robot Autonomously Performs Key Step In Gallbladder Surgery

 
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Researchers at Johns Hopkins have used a robotic system to autonomously perform a key part of gallbladder surgery without a surgeon's hand. Lead author Axel Krieger says it could take five to 10 years before an autonomous robotic system will reach human trials and expects regulatory hurdles.

Kris Joshi Named Norstella CEO, Prioritizes AI Innovation

 
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Joshi joins the parent company of Citeline, home of Medtech Insight, to focus on AI, business harmonization and long-term growth.

Thena Capital’s New Fund Up And Running With £1M Investment In Plexāā’s Breast Cancer Device

 

Thena Capital, the first UK-based early-stage specialist medtech firm, has made its first investment since closing its £50m fund. Medtech Insight spoke with general partner Pamela Walker Geddes to gain insight into Thena Capital’s investment strategy.


Milner Pitch Day: Multiomic Pathology, Microcancer Avatars And Cell Morphology Intelligence

 

The Milner Institute, the on-campus hub for start-up acceleration at Cambridge University, hosted its annual Pitch Day on July 1. Start-ups Panakeia, PathwayBio and Sentinal4D presented diagnostic technologies.

Corify Care, Mayo Clinic Join Forces To Advance AI-Driven Global Cardiac Mapping Platform

 
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Corify Care’s CEO said the company aims to submit its 510(k) application to the US FDA by year-end, targeting market clearance in 2026. The company hopes its collaboration with the Mayo Clinic will help speed adoption of ACORYS, a noninvasive mapping technology for use in complex cardiac ablations.

Medtronic’s ‘Strategic Expansion’ Into Remote Monitoring

 

“The Corsano wearable strengthens Medtronic’s acute care and monitoring portfolio,” Marc De Martini, vice president at Medtronic, told Medtech Insight.

FDA Publishes Final Cybersecurity Guidance To Replace Final Cybersecurity Guidance

 

The US FDA has issued an updated final guidance document on cybersecurity considerations for medical device manufacturers that replaces a previous final guidance the agency issued in 2023.


No Strings Attached: Big Players Chase Insulet In Fast-Growing Tubeless Insulin Pump Market

 
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Medtronic, Tandem and Beta Bionics are gearing up to bring tubeless patch pumps to market, chasing Insulet’s Omnipod 5, the only FDA-cleared patch pump for type 1 and type 2 diabetes. Analysts expect tubeless models to eventually displace durable pumps.

UK Center To Develop Brain Stimulation Devices Opens

 

Backed by £50m of UK government funding, the new research center will delve into neural dynamics to develop novel devices ranging from brain implants to wearables.

Surgical Robotics CEOs Talk Metrics For Success, Valuations, Competition And IPO Outlook

 
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Leaders of robotic systems companies Distalmotion, Neocis and Noah Medical discussed success metrics, competition and funding. Institutional investors are focusing on utilization, procedure rates and a clear path to profitability as the IPO window reopens, BTIG analyst Ryan Zimmerman said.

Dxcover Launches US Operations With New Headquarters In Tennessee

 

Dxcover sets up new Clinical Laboratory Improvement Amendments (CLIA) lab in Franklin, Tennessee.


Fallouh Healthcare Receives Grant Funding From Innovate UK

 

Fallouh Healthcare has received £305,050 in grant funding from Innovate UK as part of the European Union’s Eureka Eurostars program. The company aims to detect cardiac tamponade, a condition that affects patients after heart surgery. Currently, there is no way to accurately diagnose the condition.

Will Kennedy And Makary Come To Terms On User Fees During Next Round Of MDUFA Negotiations?

 

It’s no secret that Marty Makary and Robert F. Kennedy Jr. have a different take on user fees, with Makary viewing them as a funding necessity and Kennedy as a corrupting influence. But will they find a way to strike a balance during the next MDUFA reauthorization talks so each can claim victory?

FDA Regulations ‘Lock Out’ Clinically Proven Neuromodulation Devices

 

Flow Neuroscience's neuromodulation headset for the treatment of depression is approved and marketed in the EU. However, two years on, the company is still waiting for US FDA approval despite being assigned breakthrough device designation.

Tarver And Makary Emphasize Commitment To At-Home Healthcare Innovations In FDA Podcast

 
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FDA officials Michelle Tarver and Marty Makary discussed advancements in home healthcare during a podcast. They highlighted the importance of continuous glucose monitors, emphasized home healthcare's benefits for chronic diseases, and mentioned the agency's efforts to streamline device development.