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Apple Inc.

Latest From Apple Inc.

ACC Results Recap Part I: Low-Risk TAVR Trials Bring Good News For Edwards And Medtronic; Apple Watch Detects AFib In Apple Heart Study

Medtech Insight's Results Recap is a regular feature covering the major device trial results compiled by MedDeviceTracker. This is the first of three special Results Recaps covering trial data presented at the American College of Cardiology Scientific Sessions in New Orleans, March 16-18, including presentations on Medtronic and Edwards Lifesciences’ transcatheter aortic valves and Apple’s Apple Watch, which now has electrocardiography capabilities.

Tracking Trials Research & Development

CDRH Will Experiment With Pre-Cert Pilot Participants To Figure Out Right Metrics, Processes

With a regulatory framework and test plan in place, US FDA says it will use the rest of the year to run experiments in its pre-cert pilot program to figure out what metrics it needs to gather and processes it needs to develop to make the new paradigm for digital health products a reality. The agency says it plans to update stakeholders as needed on its progress.

Digital Health Regulation

2019 Will Be Testing Period For US FDA's Novel Pre-Cert Paradigm For Digital Health

In 2019, FDA will be taking steps to perform real-world testing of the effectiveness of its pre-cert program for health software and whether the program can be carried out within the agency's current regulatory authorities. The efforts come after more than a year of development and some pushback about statutory overreach and patient safety.

Regulation Digital Health

Start-Up Spotlight: Small Lens In Eardrum Hopes To Make Big Soundwaves In Hearing Aid Market

A new hearing aid lets users enjoy the full range of normal hearing frequencies, activated by a contact lens on the eardrum. The hearing aid from Earlens Corp. also provides audio gain without feedback. In October, the company completed an $87m round of financing, which will help launch its next-generation hearing aid, which employs magnetic induction for further hearing refinement.

Start-up Spotlight StartUps and SMEs
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Company Information

  • Industry
  • Digital Health
  • Medical Devices
  • Therapeutic Areas
  • Non-Specific
  • Alias(es)
  • Apple Computer Inc.
  • Ownership
  • Public
  • Headquarters
  • Worldwide
    • North America
      • USA
  • Parent & Subsidiaries
  • Apple Inc.
  • Senior Management
  • Tim Cook, CEO
    Luca Maestri, SVP, CFO
    Jeff Williams, COO
    Philip W Schiller, SVP, WW Mktg.
  • Contact Info
  • Apple Inc.
    Phone: (408) 996-1010
    One Apple Park Way
    Cupertino, CA 95014
    USA
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