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COVID-19: LifeSignals, VitalConnect Get Green Light For ECG Remote Monitoring

 
• By Marion Webb

Two California-based ECG remote monitoring companies see rising demand for their solutions during the COVID-19 crisis.

vital sign monitoring concept. 3d rendering. abstract mixed media.

Two California-based makers of electrocardiogram (ECG) remote monitoring patches have been given the go-ahead to sell their devices in key markets.

Fremont-based LifeSignals said it received the CE mark for its Biosensor Patch 1A, clearing the way for marketing in Europe,...

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More from Digital Technologies

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.

FDA ‘Regulatory Accelerator’ Aims To Speed Digital Health Development

 
• By Elizabeth Orr

The US FDA has launched the Regulatory Accelerator to expedite digital health product development. This includes resources like a Resource Index for Innovators, a Medical Device Software Guidance Navigator, and best practices for early meetings.

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Edwards Lifesciences Lowers Tariff Impact Forecast, Keeps Gross Margin Guidance Intact

 
• By Shubham Singh

The company reaffirmed its guidance for adjusted gross profit margin for the full year 2025 to remain within the original range of 78% to 79%. Chief financial officer Scott Ullem attributed this to currency and tariff dynamics.

Olympus, Revival Co-Found Swan In $458M Deal, Face Tech and Regulatory Hurdles

 
• By Marion Webb

Olympus and Revival Healthcare Capital have launched Swan Endosurgical in a $458m milestone-based joint venture to develop a robotic platform for endoluminal surgery. The deal combines Olympus’ GI expertise with Revival’s start-up model, but will face technical and regulatory hurdles.

Alternative Funding Sources Emerge Amid Biotech Industry Challenges

 
• By Jo Shorthouse

The biotech funding landscape is undergoing a fundamental shift. With traditional VC becoming increasingly cautious and selective, industry executives are exploring new avenues for capital. Conversely, this evolution may ultimately benefit the sector's long-term sustainability.