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Executive Exclusives

Set Alert for Executive Exclusives and Hindsight 20/20

Sinaptica On Precision Neuromodulation To Combat Alzheimer’s: ‘No Drug Dares Go After Moderate Patients’

CEO Ken Mariash and scientific co-founder Giacomo Koch discuss plans for a Phase 3 trial in 2025 supporting Sinaptica’s combination of transcranial magnetic stimulation, electroencephalography and machine learning to slow Alzheimer’s progression. Potential synergies with anti-amyloid drugs, reflections on the US FDA’s TAP program, and insight into the company’s machine learning capabilities.

Research & Development Neurology

Quantum Surgical Plans Expansion In Asia, Additional EU, US Indications For Oncology Surgical Robot Epione

Quantum Surgical is on a mission to democratize minimally invasive cancer treatment. Its surgical robot Epione can treat inoperable abdominal and lung tumors using ablation. The company has treated over 500 patients across Europe and the US and secured €30m in funding to fuel expansion into Asia and into new cancer indications.

Europe France

DeepWell DTx Brings Mental Health To Meta Store

Zengence, the first virtual reality game intended to help reduce stress, became available earlier this summer. We talked to DeepWell DTx founder Ryan Douglas about the road ahead.

Digital Health Commercial

Fatty Liver Disease Drug Approval Opens New Patient Population In Imaging Market

The accelerated approval of Rezdiffra, the first drug authorized by the FDA to treat metabolic dysfunction-associated steatohepatitis (MASH), presents a large opportunity for imaging and diagnostic devices.

Regulation Liver & Hepatic

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

Orange Book Is The New Spat: FTC Seeks Removal Of ‘Improperly’ Listed Medical Device Patents

The US Federal Trade Commission wants to clean up the FDA’s Orange Book by purging medical device patents that the commission says should not be in the listing. The FTC argues improper patents in the Orange Book block lower-cost generic equivalents from coming to market. Medtech Insight spoke to attorney Sara Koblitz about the FTC’s delisting push.

FDA Patents

Podcast: Lung Life AI CEO Shares Regulatory And Reimbursement Journey For Lung Cancer Diagnostic

In this episode, Medtech Insight reporter Natasha Barrow speaks to LungLife AI CEO Paul Pagano. Lung Life AI is a US-based AIM-listed medical technology company that has developed a liquid biopsy test for the early detection of lung cancer called Lung LB. Pagano runs through the highlights of Lung Life AI journey to date and its future ambition for a strategic partnership. He also provides advice to similar diagnostic companies seeking reimbursement andcompliance with the US FDA Lab Developed Test ruling.

Clinicians: ‘Show Me The Impact And Outcomes Of AI Tools’

Royal Philips’ ninth annual Future Health Index global report reveals a growing acceptance by clinicians and health care stakeholders of virtual care and AI-enabled innovation. These tools can address workforce shortages, financial burdens and growing demand for care, said chief innovation and strategy officer Shez Partovi.

Leadership Artificial Intelligence

UK Regulation: In A System Of Regulatory Reliance, PMS Assumes A Central Role

Taylor Wessing partner Alison Dennis explains why post market surveillance is an MHRA priority as Great Britain’s medical device regulatory system takes shape.

United Kingdom Regulation

Class I Device For Methadone Dosing Decreases Costs, Save Lives

Sonara Health founder Michael Giles talks take-home methadone treatments, remote patient monitoring and sponsoring legislation to fund opioid treatment programs.

Behavioral Health Digital Health

Floreo CEO Champions FDA Path For Autism VR Therapy

Vijay Ravindran, founder of autism therapy digital therapeutic firm Floreo, spoke to Medtech Insight about working with the FDA, and why the TAP pilot made sense for them.

Digital Health Reimbursement

‘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

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

AI Act: How To Preserve EU’s Industrial Competitiveness Through Proportionate Regulation

The AI medtech revolution could be a “huge, missed opportunity” for the EU without an effective and efficient regulatory infrastructure. Answers are needed fast, MedTech Europe’s Oliver Bisazza said during a recent interview.

Europe EU

Click Therapeutics Anticipates Pharma Will Begin Developing Digital Drugs From Clinical Stage

Leading digital therapeutic maker’s CEO David Benshoof Klein and CMO Shaheen Lakhan discuss outlook on the DTx space, priorities going forward, and what makes Click a standout player in a changing game.

Digital Health Business Strategies
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