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Singapore Regulators To Streamline Framework For Software And Apps

 
• By Neena Brizmohun

A consultation by Singaporean regulators on telehealth devices is seeking to speed access to new and innovative medical device software and apps.

Singapore’s Health Sciences Authority (HSA) has proposed a set of guidelines on telehealth devices that include clarification on which products would qualify as medical devices and which of the agency’s evaluation pathways – immediate, expedited, abridged or full – they should follow.

Innovation in telehealth technology has advanced at a rapid pace and the HSA wants to refine and streamline its regulatory framework for medical device

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Precision Neuroscience’s FDA Clearance For Core Component Of Brain Implant Expected to Accelerate R&D

 
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“We believe [the SAPIEN M3] launch alongside PASCAL and EVOQUE will help support the company’s target of $2bn in transcatheter mitral and tricuspid therapies sales by 2030,” noted analysts from Leerink Partners.

Dexcom Wins FDA Nod For 15-Day G7 CGM, Closing Gap With Abbott’s 14-Day FreeStyle Libre

 
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More from Policy & Regulation

New Treatment For Chronic Facial Pain Could Launch By Fall 2025

 
• By Elizabeth Orr

NeuroOne is preparing to submit its OneRF Trigeminal Nerve Ablation System to the US FDA for treating trigeminal neuralgia, a chronic facial pain condition. CEO Dave Rosa told Medtech Insight that he expects a possible product launch by fall 2025.

Don’t Sleep On Inspections: Experts Warn FDA Maintains Enforcement Resources

 
• By Brian Bossetta

Manufacturers of medical products would be foolish to think that recent upheavals at the US FDA will result in a lack of inspections in the coming years. A panel of experts discussed the current state of inspections during a webinar hosted by the Food and Drug Law Institute.

Global Medtech Guidance Tracker: April 2025

 
• By Vibha Sharma

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. 25 documents have been posted on the tracker since its last update.