2. >>Business

Starts & Stops: Small Players Advance Innovations, Three Trials Suspended

 
• By Tina Tan

Starts & Stops is a regular feature highlighting the Medtech Insight editors' picks of noteworthy medtech clinical trial initiations, completions and suspensions from the previous month. July's selection includes three trials that had to be terminated unexpectedly.

Clinical Trial

Several smaller, venture-backed medtech players initiated new clinical trials in July, as recorded by Informa's Meddevicetracker. Among the notable studies started last month are Bigfoot Biomedical Inc.'s US study of the Bigfoot smartloop artificial pancreas system for type 1 diabetes patients; ALung Technologies Inc.'s phase III study of its Hemolung RAS, a respiratory dialysis system that is also enrolled in the US FDA's Expedited Access Pathway; and Mercator MedSystems Inc.'s phase II pilot trial of its Bullfrog microinfusion device for treating critical limb ischemia. (Also see "Mercator Launches Trial Of Micro-Infusion Device For Lower-Leg Obstruction" - Medtech Insight, 28 July, 2016.)

There were also three companies that suspended their trials last month, all for different reasons. Sweden's XVIVO Perfusion AB, a company that has developed an ex-vivo lung perfusion (EVLP) technology...

More from Clinical Trials

Abbott Announces FDA Approval Of Tendyne Transcatheter Mitral Valve Replacement System

 
• By Marion Webb

Abbott received the US FDA nod for its Tendyne system, offering a minimally invasive alternative to replace the valves of patients with severe mitral valve disease who are at risk for open-heart surgery.

Cardiosense Advances Noninvasive Heart Monitoring With Final Validation Study

 
• By Marion Webb

Cardiosense has launched a nationwide clinical study, SEISMIC-HF II, to validate its non-invasive, AI-powered technology for monitoring heart failure. The data will be used to file for US regulatory clearance of the Cardiosense heart failure monitoring platform.

Roche Diagnostics Day 2025: ‘We Need To Become A Leader In Decentralized Testing’

 
• By Natasha Barrow

Roche aims to grow its diagnostics sales by mid to high single digits, said CEO of Roche Diagnostics Matt Sause. The company unveiled the Axelios synthesis and sequencing solution and discussed its “long-term commitment” to China, as well as its business strategy for the next five years.

Salvia Bioelectronics Secures $60M In Series B To Advance Chronic Migraine Implant, Eyes US Trials

 
• By Marion Webb

Medtech Insight spoke with Hubert Martens, CEO of Netherlands-based neuromodulation company Salvia Bioelectronics, about the company’s innovative implant for treating chronic migraines, ongoing clinical trials and plans for US clinical trials and commercialization.

More from R&D

ConcertAI Launches Generative AI-Powered Precision Suite

 
• By Natasha Barrow

Valued at over $1.9bn, ConcertAI is building on its pre-existing multi-agentic AI SaaS solution CARAai to bring life science customers the new Precision suite of applications: Precision Explorer, Precision Trials, Precision GTM and Precision360.

Handheld Diagnostics: A Resurging Category That is Here to Stay

 
• By Barnaby Pickering

Handheld diagnostics are more powerful, accessible and clinically relevant than ever. Medtech Insight spoke to companies behind such technologies to learn how they work and discuss their commercial models.

Roche Diagnostics Day 2025: ‘We Need To Become A Leader In Decentralized Testing’

 
• By Natasha Barrow

Roche aims to grow its diagnostics sales by mid to high single digits, said CEO of Roche Diagnostics Matt Sause. The company unveiled the Axelios synthesis and sequencing solution and discussed its “long-term commitment” to China, as well as its business strategy for the next five years.