Pathways' Pick of the Week: UK's Innovative Devices Pathway

article image

MHRA has selected the first devices for its eight devices for its IDAP pilot. Excerpted from Pathways' Picks February 21: FDA in London, UK Innovative Devices, Maisel Retirement, and More.

UK Medicines and Healthcare products Regulatory Agency has selected eight devices to participate in its Innovative Devices Access Pathway (IDAP) pilot. Under the experimental pathway, the products will get extra help navigating clinical study, regulatory, health technology assessment, and NHS market access steps and benefit from accelerated reviews. The eight selected devices are:

  • Amyloid Plasma Panel: A Roche Diagnostics biomarker test to triage potential Alzheimer’s disease patients
  • Algorithm-based infection prediction test: A Presymptom Health molecular IVD paired with a cloud-based algorithm
  • Edison histotripsy device: A HistoSonics ultrasound device designed to target liver cancer
  • EarSwitch: Device, from EarSwitch, designed to detect oxygen levels from the inner ear-canal, irrespective of skin pigmentation
  • Multiple sclerosis fatigue app: King’s College London- and Avegen-developed app to guide MS-fatigue symptom management
  • LVOne test: Upfront Diagnostics’ portable blood test for stroke.
  • Neutropenia self-test: 52 North Health test for life-threatening chemotherapy side effect
  • COPD prediction tool: Lenus Health AI-based tool to gauge chronic obstructive pulmonary disease risk
Continue reading Pathways’ picks here.

Articles from David Filmore:

Regulatory & Reimbursement

CMS Opens New Reimbursement Avenue For Digital Therapeutics

The Medicare agency for the first time says it will reimburse directly for FDA-authorized stand-alone mental health software. While the proposed policy has limitations, digital therapeutics advocates suggest it sets a good precedent for a field that has up until now run into a brick wall with the federal insurance system.

Read Article