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New Data Gives Adherium Fuel To Accelerate Digital Tech Adoption in Drug Sector

 
• By Tina Tan

With nearly 40 published peer-reviewed journal articles under its belt, Adherium is hoping that the latest clinical data which underlines the ability of the company's Smartinhaler to improve outcomes for children with poorly controlled asthma should boost the pairing of digital technologies with drugs.

Adherium Ltd.'s Smartinhaler electronic monitoring tool – which incorporates reminder alarms and feedback – used with asthma medication delivery in children with poorly controlled asthma not only helps reduce the frequency of exacerbations, but also improves medication adherence significantly.

STAAR (the Study of Asthma Adherence Reminders) is the first trial of its kind to show that regular alarms and...

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CorTec Begins First Human Trial Of Wireless Brain Implant For Stroke Rehab

 
• By Marion Webb

Germany’s CorTec has implanted its wireless brain-computer interface in a stroke patient, launching a trial to test safety and whether brain stimulation during physical therapy can help restore movement where traditional rehab has failed.

NIH-Backed Scanner Opens New Frontier For Understanding The Human Brain

 
• By Brian Bossetta

A new MRI scanner developed by a team of scientists working with the National Institutes of Health marks a milestone in understanding the complexities of the human brain. Andrea Beckel-Mitchener with the NIH Brain Initiative discusses the significance of this potentially game-changing device.

NHS Orders Halt On Unapproved AI Scribes, Vendors Rush To Self-Certify

 
• By Natasha Barrow

NHS England's national chief clinical information officer issued a cease and desist on unapproved ambient voice technology and AI scribes. The move caused confusion among AVT vendors and went beyond joint MHRA/NHS guidance. IMed consultant Ben Austin shares his perspective.

Boston Scientific Raises Outlook … Again: Headwinds Offset By EP And Watchman

 
• By Natasha Barrow

Agent drug coated balloon, Watchman product sales, and electrophysiology (EP) business unit growth offset Acurate discontinuation and tariff headwinds. CEO Michael Mahoney shouted out coronary therapies business and answered questions on CMS proposed Ambulatory Surgical Center codes.

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FDA’s Small Business Eligibility Process Gets Update Before New Fiscal Year

 
• By Elizabeth Orr

The US FDA has updated its guidance document on small business eligibility determinations for medical device firms. Industry observers urge companies to ask for the status early to avoid any potential hold-ups.

Bipartisan Senate Bill Would Give Patients ‘True Price Tag’ Prior To Care

 
• By Brian Bossetta

Pending legislation seeks to address what the sponsors argue is a lack of transparency in medical billing. If enacted, the bill would provide patients with the costs of procedures and medications before receiving them. A data collection expert discusses what the bill could mean for patients.

How Notified Bodies Would Like Future EU Medtech Governance To Pan Out

 
• By Amanda Maxwell

Notified bodies are calling for their key role, as the technical, regulatory and clinical ‘extended arm’ of regulatory authorities, to remain central to the EU medtech conformity assessment process.