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Cumulus Neuroscience Joins Transatlantic Hunt For Alzheimer’s Blood And Digital Biomarkers

Cumulus Neuroscience has been granted £1.2m from Innovate UK to validate AccelADx, an AI-powered, non-invasive Alzheimer’s screening test that combines EEG and tablet-based assessments, as part of a transatlantic study investigating digital and blood-based biomarkers for Alzheimer's dementia.

Research & Development Financing

Lucid Diagnostics Seeks Clear Path To US Reimbursement For Esophageal Precancer Test

Lishan Aklog, CEO of New York-based Lucid Diagnostics, has a long-term vision to provide the paradigm of prevention-to-treatment care for esophageal cancer. In the short term, the company anticipates a favorable outcome from an upcoming pivotal Medicare assessment of its early screening technology.

Innovation Cancer

Endoron Staples Down $10M To ‘Revolutionize’ Abdominal Aortic Aneurysm Repair

Endoron Medical won $10m in series A funding from European venture capital firm Sofinnova Partners and the European Innovation Council Fund. The capital will propel Aortoseal – Endoron's endograft stapling solution for abdominal aortic aneurysm – through clinical validation in its US Food and Drug Administration early feasibility study.

Europe US States

Sinaptica’s Breakthrough Device Could Slow Brain Atrophy In Alzheimer’s Patients – Study

In a pilot study building on previously published Phase 2 trial results, Sinaptica’s precision therapy, combining repetitive transcranial magnetic stimulation with EEG monitoring and artificial intelligence, showed macro- and micro-structural grey matter preservation and increased functional connectivity in Alzheimer’s patients versus a sham treatment arm.

Research & Development Financing

Syphilis OTC Test Developer NOWDiagnostics Raises $22.5M

The Series B funding round led by DigitalDx Ventures will support development and commercialization of more than 30 rapid diagnostic tests in NOWDx’s clinical research pipeline, including its First To Know Syphilis OTC test, currently under US FDA De Novo review, which provides at-home results in minutes.

Financing Diagnostics

FDA To Add Ophthalmic And Orthopedic Devices To TAP Pilot

The program, which brings together innovators and device industry stakeholders, helps ease the path to market for novel devices. 

Regulation FDA

EU Regulatory Roundup, May And June 2024: Sweeping New Proposals Take Medtech By Surprise

During this period of intense regulatory pressure for the medtech industry, work has been ongoing in the background to try and find a better way forward for the medtech industry, for innovation and for patients.

Europe EU

News We're Watching: Change Healthcare Details Breach Scope, CHAI Releases AI Assurance Draft, FDA Partners With Gates Foundation

This week, Change Healthcare admittedi ts February breach revealed sensitive information like medical diagnoses and Social Security Numbers; the Coalition for Health Artificial Intelligence released its Assurance Standards Guide and Reporting Checklist for developers; and the FDA announced public meetings in July on IVD classification, the Home as a Health Care Hub initiative, and device sterilization.

Regulation Digital Health

Healthtech Leaders Discuss Impact (And Risks) Of Generative AI and AI In Health Care

AI and generative AI ruled much of the discussion at HLTH Europe 2024. A panel of health care leaders from Microsoft, Philips, insitro and Johnson & Johnson discussed how these new technologies are already transforming health care and pointed to risks and challenges.

HLTH Artificial Intelligence

MedTech Forum: Experts Suggest Short And Long-Term Solutions To EU’s Innovation Crisis

After focusing on the severity of the EU’s regulatory innovation crisis, Medtech Insight now reports on discussions in Austria last month on a range of changes that could improve the outlook for cutting-edge products.

Europe EU

MedTech Forum: Is Global Regulatory Convergence Needed To Address EU’s Slow Innovation Exodus?

Does the difference in the height of the respective regulatory bars for innovation in the EU and US matter? And how severe are the problems being created by companies choosing to launch new products outside the EU? Hear the views of speakers at the Medtech Forum in Vienna in this first section of a two-part report from a session at the conference on innovation.

Europe EU

Diversity Enrichment: US FDA Guidance Suggests Sponsors May Need To Overenroll Key Groups

New draft guidance on clinical trial diversity action plans pushes for disproportionately high enrollment of traditionally underrepresented groups, while also asking companies to tailor global programs to US populations and consider diversity aspects that Congress did not outline. 

Diversity & Inclusion Clinical Trials

UK Medical Device Firm Owen Mumford Launches Pelvic Health Consumer Brand

UK medical devices manufacturer Owen Mumford moves into consumer health with umbrella brand Clariti and OTC relaunch of at-home vaginismus and dyspareunia treatment Amielle Comfort.

Europe United Kingdom

‘Is This Doomsday Concern, Or Is It Reality?’ Verily CMO On AI’s Future, Lightpath Metabolic, More

Andrew Trister, Verily’s chief medical and scientific officer, spoke with Medtech Insight at the HLTH Europe conference about Verily’s newly launched Lightpath Metabolic solution, featuring GLP-1 prescription, AI and strengthened clinical support. Trister also talked about plans for the Study Watch and offered views on the Alzheimer’s research landscape and AI development and regulation in a new era of uncertainty.

HLTH Artificial Intelligence

Outdated Technology Keeping Surgeons From Operating At Their Best: Medtronic Report

Cutting edge technology could significantly enhance operating room efficiency, according to a new report from Medtronic. The problem, however, is that most ORs don’t have it.

Artificial Intelligence Surgical Procedures

Implantica CEO On Potential New Standard Of Care For Treating GERD: RefluxStop

Implantica AG continues European rollout of RefluxStop, a non-active, laparoscopically implanted device for treating gastroesophageal reflux disease (GERD) that offers key advantages over other surgical interventions and drug therapy, according to the company. CEO Peter Forsell discusses global market opportunity and the firm’s growing body of research to support reimbursement.

Europe United Kingdom