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Wi-Fi Failures, Custom Tech And Other Challenges Of Bringing Specialty Care Into Patients’ Homes
The CEOs Reimagine Care, Cortica and Inbound Health, part of the rising trend to bring specialty and acute care programs into the home, joined a panel at the DHIS West conference to discuss their views on the future of virtual and at-home delivery of complex care and shared some of their own challenges they encountered.
News We’re Watching: Medtronic To Buy EOFLow, Neuralink Cleared For Human Trials, NICE Backs Genetic Tests
This week, Medtronic said it would pay $738m for insulin patch firm EOFlow; Neuralink got an FDA OK for first-in-human trials; and UK agency NICE backed genetic tests for stroke patients and digital therapeutics for mental health conditions.
White House Takes Steps To Advance ‘Responsible’ AI That ‘Upholds Democratic Values’
The White House Office of Science and Technology Policy has released an updated national strategic framework outlining priorities and goals for federal investment in AI. Industry executive Peter Shen weighs in on the plan.
EPA Gives Stakeholders Additional 15 Days For EtO Comments
The deadline for comments on the Environmental Protection Agency proposal, which trade groups say could lead to device shortages if implemented, has been moved from 12 June to 27 June.
‘Wait-and-See Time’: Panel Predicts Limited Congressional Action On Devices This Year
An expert panel at the FDLI annual meeting expects the US Congress to want to see more results from recent legislation on devices before it moves ahead with further FDA reform. Though, pandemic-related measures remain a priority.
Integra LifeSciences Recalls Products From Boston Facility, Takes Financial Hit
After consulting with the US FDA, Integra Life Sciences initiated a recall of products produced in its Boston Facility. The company expects losses of $22m.
What Does The EU Regulation On HTA Mean For Medtech And When Will It Apply?
Several updates have come in recent weeks on the European Commission’s planned new Regulation on HTA, including a list of stakeholder members and updated rolling timeline. Medtech Insight explains how and when this legislation will affect the medtech sector.
Companies Targeted By FTC Using Penalty Offense Authority Have Strong Defense, Attorney Says
John Villafranco, partner at Kelly Drye & Warren LLP, says the US FTC’s ability to obtain monetary relief using the penalty offense mechanism is questionable both on statutory and Constitutional grounds. Marketers faced with civil penalties – for example, for alleged inadequately substantiated health claims – should stand their ground, he suggests in a recent interview.
News We’re Watching: Premom Data Privacy Settlement, Labcorp Owes $372m For Patent Violations, Elixir Stent Trial Success
This week, the DC Attorney General announced a settlement with ovulation-tracking app Premom; a novel scoliosis treatment won FDA approval; research showed Fractyl Health’s Rejuva delivery system can deliver gene therapy directly to the pancreas; and BearCare recalled a thermometer over burn risks.
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