Market Pathways Top 5 June 2022

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The top five Market Pathways articles posted in June to, chosen by readers and editors, include EU pressure to amp up MDR compliance, Innara's strategy to avoid capex constraints, Senate encouragement of PCCP use, and two of our recurring columns: Pathways' Picks and Pathways' Document Depot.

The top five Market Pathways June articles.

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#1: EU Commission Ratchets Up Pressure on Companies to Expedite MDR Compliance

EU guidance group puts industry on notice about slow or incomplete Medical Device Regulation compliance efforts. National competent authorities are also stepping up urgency, although they more directly acknowledge the “shared responsibility” to contend with MDR challenges.

#2: Innara Health Aims to Offset Reimbursement Gap

The revamping of its NTrainer neonatal feeding system with digital enhancements will enable Innara Health to implement a subscription-based pricing model that overcomes lagging reimbursement and traditional budgetary constraints associated with hospital capex budgets.

#3: Change Control Plans to Avoid New FDA Submissions Get Support in Senate

FDA has previously introduced the concept of “predetermined change control plans” for adaptive machine learning-based devices. Legislation that is now part of the Senate user fee bill is intended to encourage the agency to apply that approach—where predefined modifications don’t require new submissions—more routinely, and not just for software.

#4: Pathways’ Picks June 1: Brazil GMP Reg, Senate Dx Reforms, FDA Pre-Sub Norms

In this week’s roundup: Brazil’s ANVISA clarified good manufacturing practice certification procedures; the US Senate sets a date to mark up newly introduced legislation to reauthorize user fees and reform diagnostics oversight; FDA opens up final COVID-19 pre-submissions door and considers other “back to normal” steps; a panel meeting on AI skin analyzers; SUNSET rule withdrawn; and updated Saudi clinical trials guidance.

#5: Pathways Document Depot: Cataloging Medtech Policy

A sortable and searchable running inventory of global medtech regulatory and policy official documents, including rules, guidance documents, memos, white papers, and more from national authorities, non-governmental groups, and global organizations.


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Articles from Nancy Dvorin:

Perspective & Commentary

Digital Edition: MedTech Strategist April 2023

Emerging cardiovascular companies are staking claims in pulsed field ablation and percutaneous ventricular assist devices. Biogen Digital Health identifies and validates digital biomarkers to accelerate neuroscience drug development; we look at their program to personalize multiple sclerosis care. Also in this issue, part 2 of our feature on Fogarty Innovation and profiles of start-ups Hyfe and Neuro One.

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