Digital Health Roundup: Exec Chats With Illumina, Bloom, AngelMed; M&A, Funding; FDA Down-Classifies Apps

In this roundup feature focusing on new developments in digital health, Medtech Insight spotlights IBM Watson Health’s divestiture and other financing news, Exec Chats with Illumina, AngelMed and Bloom, Philips’ new hand-held ultrasound device and autonomous robotic surgery, as well as the latest FDA news on digital health.

Digital Health Roundup
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Philips Announces Major Investment In US Manufacturing And Expansion Of Pennsylvania Facility

 

Philips says the expansion of its facility in Reedsville, PA, will not only boost its capacity to produce AI-enabled ultrasounds that are used in hospitals across the US but will also create 120 well-paying jobs.

Breathing Easy: Freespira Works To Expand Access To Panic And PTSD Treatment

 
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Freespira’s device has been FDA-approved to treat panic disorders and PTSD. CEO Joe Perekupka told Medtech Insight the company’s innovative approach includes patient coaching, insurance partnerships to identify potential users, and lobbying for broader insurance coverage for digital therapeutics.

After Thought-Control Demo, Synchron Plans Pilot Study With Upgraded BCI On Path To Pivotal Trial

 
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Synchron is preparing a pilot study of its fully wireless, second-gen brain-computer interface after an ALS patient controlled an iPad solely by thought. If all goes as planned, Synchron’s BCI will move into pivotal trials in 2026.

Exact Sciences Reveals Thinking On CRC Liquid Biopsy After Freenome Deal

 

Exact Sciences has entered into an exclusive licensing agreement with Freenome, stipulating clinical benchmarks and a first-line rating in the USPSTF guidelines. Medtech Insight interviewed screening CMO Paul Limburg about CRC screening and Exact’s strategy on liquid biopsy.

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Nyxoah Launches FDA-Cleared Genio System For OSA As Rival Inspire Files Patent Suit

 
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After receiving FDA clearance for its Genio sleep apnea implant, Nyxoah plans a major US rollout despite a patent suit from rival Inspire Medical. Genio offers bilateral nerve stimulation as a CPAP alternative, with strong trial results.

Inaccurate Carbon Dioxide Readings Prompt Class I Recall Of Draeger Ventilation Filters

 

Draeger Medical has recalled certain SafeStar and TwinStar ventilation filters after reports of serious injuries caused by misleading carbon dioxide readings.

UK MHRA Ready To Evolve Approach To In-House Manufactured Medtech

 
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The UK device regulator wants to align health institution device exemptions with its evolving policy of agile regulation of medtech in the British market. It asks stakeholders to complete a survey by Sept. 15.