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US FDA Permits AliveCor's AI Mobile ECG To Measure QTc In COVID-19 Patients

 
• By Marion Webb

AliveCor wins US FDA permission to use its mobile ECG to detect heart problems caused by drugs to treat COVID-19 patients.

Heart disorder and atrial fibrillation ecg as a coronary cardiac attack with irregular and normal organ rhythm as a chest discomfort disease concept in a 3D illustration style.

AliveCor Inc., which markets a six-lead consumer electrocardiography (ECG) device called KardiaMobile 6L for at-home use and in clinical settings to detect heart arrythmias, announced yesterday that the US Food and Drug Administration permitted an expanded use of the device to detect prolonged heartbeats caused by medications used to treat COVID-19.

The announcement follows a new guidance issued by the FDA on 20 March that allows manufacturers of patient-monitoring devices to add or improve remote-monitoring

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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.

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

 
• By Marion Webb

Precision’s recent FDA clearance for a core part of its next-generation wireless brain-computer interface system opens the pathway to a safer, more humane BCI for researchers to use compared to higher-risk intracortical arrays, according to BCI expert Naveen Rao.

Edwards Mitral Valve Replacement System SAPIEN M3 Receives CE Mark

 
• By Natasha Barrow

“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

 
• By Marion Webb

Dexcom announced it received US clearance for its 15-day CGM, which has a MARD of 8.0% and is expected to launch in the second half of 2025 to allow for integration with insulin pumps.

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California Medtech Firms Resolve Patent Dispute Over Delivery Catheters

 
• By Brian Bossetta

Route 92 says it has reached a settlement with Q’Apel Medical over patent claims concerning its Tenzing delivery catheters.

Does Makary’s Reorg Choice Mark FDA Turning Point?

 
• By Michael McCaughan

US FDA Commissioner Martin Makary’s disavowal of a proposed reorganization plan may be an important turning point in the Trump Administration. The move does not improve the situation, but may mean the administration stops actively making things worse.

MedTech Europe’s Bisazza Urges Action As US Tariffs Jeopardize Critical Global Supply Chains

 
• By Amanda Maxwell

The intricate assembly of medical devices, often involving over 1,000 globally sourced components, faces severe disruption due to new US tariffs. These barriers could halt production and devastate small and medium-sized enterprises (SMEs), MedTech Europe’s CEO, Oliver Bisazza, warns in an interview with Medtech Insight.