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R&D Roundup, October 2019: TCT Brings More Transcatheter Valve Results, New Product Launches, Reassuring Data On Paclitaxel Risk

 
• By Reed Miller

An overview of October’s ten most-read Medtech Insight articles on topics related to research and development of new medical technology.

R&D Roundup

Highlights of Medtech Insight’s coverage of research and development news in October include presentations of new clinical trial data at the Transcatheter Therapeutics Conference in San Francisco, several new product announcements, and the release of new data from Germany that may reassure physicians about the safety of paclitaxel-coated vascular devices.

Boston Scientific Corp.’s Acurate neo self-expanding transcatheter aortic valve replacement (TAVR) system performed worse than Edwards Lifesciences...

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FDA Regulations ‘Lock Out’ Clinically Proven Neuromodulation Devices

 
• By Natasha Barrow

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

 
• By Natasha Barrow

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

 
• By Natasha Barrow

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

 
• By Natasha Barrow

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.

More from Business

Home-Testing Added To UK National Cervical Cancer Screening Program

 
• By Natasha Barrow

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.

ADA 2025: Tandem Becomes Abbott’s Fourth Partner In Push To Advance Dual Sensor CGM Strategy

 
• By Marion Webb

Ahead of the ADA conference, Abbott announced Tandem as the fourth partner to integrate Abbott’s dual glucose-ketone sensor with automated insulin delivery. Expanded Medicare CGM coverage, FDA label expansions and new ADA guidelines position Abbott to grow its CGM footprint in a competitive market.

MHRA Opens Second AI Airlock Program For Applications

 
• By Natasha Barrow

"The AI Airlock program creates a supervised testing ground where novel technologies and challenge areas can be safely investigated," said James Pound, MHRA interim executive director of innovation and compliance.