Leadership

‘The World Doesn’t Need Another Digital Health App’ Says Health Tech Innovator Mike Trenell

 

The digital health market includes thousands of app-based solutions targeting single health conditions, but the cost, complexity and number of options “gives too many opportunities to health care systems to say no,” said Mike Trenell, Daiser CEO. The second generation of digital health might have the answers, he said.

Glucotrack Announces Successful First Human Clinical Study For Implanted CGM Device

 

Glucotrack is a step closer to marketing its implantable continuous blood glucose monitor, which met primary safety endpoints in its first human trial and is pitched as a potential alternative to existing CGM systems.

Execs On The Move: January 2025

 
• By 

An interactive look at recent executive-level company changes and promotions in the medical device and diagnostics industries.

Oxford BioDynamics' CRC Diagnostic Test Could Reduce Unnecessary Patient Follow-Ups

 

Oxford BioDynamics' blood-based colorectal cancer diagnostic test EpiSwitch NST has shown high accuracy (81-85%) and positive predictive values (57-87%) for colorectal cancer and polyps. By reducing false positives, the test could minimize unnecessary follow-up procedures.


FDA Tissue Biopsy Draft Guidance Could Boost Liquid Biopsy Adoption In Clinical Trials

 

The US Food and Drug Administration (FDA) draft guidance limits tissue biopsy collection in clinical trials to primary endpoints and specific research use cases. However, Andrew Newland, CEO of circulating tumor cell (CTC) liquid biopsy firm Angle Plc, believes that the guidance could enhance the market for liquid biopsy makers.

Front Line Medical Counts On Fast UK Access For COBRA-OS REBOA Device

 

The UK's established emergency care prehospital system potentially opens up a faster route to market for Front Line Medical Technologies's aortic occlusion device, COBRA-OS. Asha Parekh, Front Line CEO, talks to Medtech Insight about the company's different strategic approach to UK market access in comparison to North America.

Kennedy HHS Nomination Moves Ahead After Securing Key Hold-Out

 
• By 

Outreach by Kennedy and the Trump Administration appears to have quelled Sen. Cassidy’s fears about oversight of vaccine regulations and safety monitoring.

Digital Health Head Tazbaz Out At FDA

 
• By 

The former Oracle exec spent two years in the post, following founding director Bakul Patel. He’s the latest high-level resignation from the agency as the Trump transition continues.


AI-Powered Patient Alert System Can Save Time, And Lives

 

An innovative patient monitoring system developed by Danish physicians sends vital signs data directly to nurses, allowing them to keep tabs on patients without being in the room.

UK Expects Digital Healthcare And AI Boost From New Centers Of Regulatory Excellence   

 

Seven new Centers of Excellence for Regulatory Science and Innovation have been funded by the UK with a brief to investigate smart regulation of AI and digital health innovations, among other areas. Medtech Insight asked Alastair Denniston, leader of the CERSI in AI and Digital Health Technologies, to explain the significance and the goals of his center.

Trump’s Spending Freeze On Ice, But Medtech Funding Reviews Loom

 
• By 

President Trump's proposed federal spending freeze could have cut $8bn in medtech research funds. Although the proposal has been rescinded, the White House plans to review and cut spending could still affect key health research programs at CDC and NIH.

Avandra CEO Expects White House AI Czar David Sacks Will Usher In ‘Golden Age Of Innovation And Medicine’

 
• By 

Avandra CEO says the company has created the world’s largest federated network for de-identified imaging data, providing researchers access to medical images that will accelerate the advancement of clinical trials, precision medicine and AI applications.


CES 2025: Scouting Digital Health Floor With Deloitte Analysts To Discover Emerging Trends

 
• By 

During CES 2025, Medtech Insight accompanied Deloitte analysts Neal Batra and Andrew Davis to identify the biggest trends in digital health and solutions poised to transform the future of health care. Key trends included empowering consumers with actionable health data, the rising investment in specialized areas such as women’s health, and more companies pursuing regulatory clearance for health products.

February Return To Office Planned For US FDA Senior Staff, With Schedule F Reclassification On Horizon

 

New details are emerging about how the administration will implement some of President Trump’s workforce shift back to mostly in-office work.

Quibim $50m Series A To Fund High-Performance Computing And US Expansion

 

Quibim announces $50m in an oversubscribed series A funding round. Quibim CEO Ángel Alberich-Bayarri discusses his plans for the new financing and the company’s competitive edge in training AI with multimodal data.

Brenner Named FDA Acting Commissioner While Makary Awaits Senate Confirmation

 

Sara Brenner, a preventive medicine and public health physician at the US FDA who served in the first Trump administration, has been named the agency’s acting commissioner.


Guardant Health And ConcertAI Set Commercial Goals For Cancer Therapy Data-Sharing Deal

 

Guardant Health seeks to bring genomic cancer disease data into a clinical context in a new collaboration with ConcertAI aimed at designing cancer therapeutics and clinical trials, Amar Das, VP of real world evidence at Guardant Health, told Medtech Insight.

Inflammatix Receives FDA Clearance For Blood Test To Help ER Clinicians Diagnose Infections, Sepsis

 
• By 

Inflammatix received US FDA clearance to market its TriVerity Test System to help emergency departments quickly triage patients suspected of having acute infection or sepsis. Medtech Insight spoke with Inflammatix CEO Tim Sweeney about the company’s business strategy and marketing plans.

Axoft’s CEO Sees Potential For Soft Neural Implant To Help Coma Patients With Signs Of Brain Activity Communicate

 
• By 

Boston-area start-up Axoft is developing a soft brain-computer interface device to help coma patients with covert consciousness communicate. Medtech Insight spoke with Axoft’s CEO Paul Le Floch about the technology, plans for first-in-human trials and potential future applications of the device to help patients with disorders of consciousness, including patients in a coma or vegetative state, communicate.

Medtronic Launches World’s First Real-Time Self-Adjusting Deep Brain Stimulation In Europe

 

"Medtronic's device is the only DBS with adaptive capability," Amaza Reitmeier, vice president and general manager of Brain Modulation at Medtronic, told Medtech Insight. Two new BrainSense features work together to provide personalized brain stimulation for patients with Parkinson's disease.