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.

Novel Pathway For Combined Drug/IVD Trials Wins Backing Of EU Nations

 
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Broad participation by EU member states in a new pilot to test a unified procedure for evaluating applications for combined drug and IVD studies shows they recognize its value, says Monique Al, vice-chair of the Clinical Trials Coordination Group.

‘Be Quick, But Don’t Hurry’: Dexcom CEO Talks CGM Market Success

 
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Dexcom’s CEO Kevin Sayer discusses this fall’s planned launch of the 15-day G7 CGM, downplays Abbott’s dual-sensor while focusing on development of multi-analyte G8, making OTC Stelo app more “consumerish” for Europeans, and more.

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.


European Commission Asks For ‘Open Minds’ On Unified Drug/Device Research Pathway

 
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As the EU tests the feasibility of a radical “all-in-one” procedure for combined drug and IVD studies, sponsors are being urged to approach this novel framework with flexibility and openness.

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.

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.

UK MHRA Joins New Global Network For Safe Use Of AI In Healthcare

 

The UK's regulatory agency is the first to join a new international network for oversight of AI in healthcare run by a non-profit organization, HealthAI, the global agency for responsible AI in health.


Home-Testing Added To UK National Cervical Cancer Screening Program

 

NHS England will offer at-home cervical cancer self-testing kits to people who are overdue for routine screening by six months. The Department of Health and Social Care identified four HPV collection and testing combinations with highest accuracy.

Stealth Mode AI Imaging Startup Faction Imaging Raises $10M

 

Faction Imaging has come out of stealth mode following six years of research and development studying medical imaging workflows in India, Japan and the US.

GE HealthCare Launches Intraoperative Ultrasound Product Series: bkActiv S

 

GE HealthCare launches bkActiv S series – part of the bkPortfolio family of Active Imaging systems.

EU Pilot Features ‘All-In-One’ Regulatory Path For Drug/Diagnostic Trials

 
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The EU is testing a groundbreaking “all-in-one” process for reviewing combined drug and diagnostic trials via a single application for coordinated assessment.


Ceryx Medical Amasses £11M To Develop Adaptive Cardiac Pacing Technology

 

The Development Bank of Wales and London-based Parkwalk Advisors led an investment round of £5m, almost doubling Ceryx Medical's total investment to date.

SS Innovations’ SSI Mantra 3 Poised To Challenge Da Vinci In Robotic Surgery Market

 
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SS Innovations reported its first SSi Mantra 3 robotic cardiac surgery in South America as it prepares to file for US FDA de novo clearance and a CE mark. The firm aims to challenge Intuitive Surgical with a lower-cost, flexible system targeting US and European markets.

Philips Deals Itself A Strong Hand In POCUS Stakes

 
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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

 

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