ARRHYTHMIA MONITOR DIAGNOSTIC CAPACITY IS PRIMARY DOWNCLASSIFICATION FACTOR, FDA SAYS; HIMA DRAFT PETITION PROPOSES CLASS II FOR ALL ARRHYTHMIA MONITORS
This article was originally published in The Gray Sheet
Executive Summary
Arrhythmia monitors' diagnostic capacity will be a primary consideration for FDA in deciding which types of the preamendments Class III devices are eligible for downclassification, the agency says.
You may also be interested in...
EU Experts Want One-Stop-Shop EU Governance That Mimics Best Of Other Jurisdictions
It may be blue sky thinking to surmise how a new EU medtech regulatory governance structure could evolve. But with change on the horizon, experts see exciting opportunities.
How Ochre Bio Bagged Boehringer For Its RNA-Based Regenerative MASH Therapies
UK-based Ochre Bio has signed its first major deal with Boehringer Ingelheim. Scrip talked to its co-founder and CEO, Jack O’Meara, about its human tissue-based drug discovery platform, its resulting RNA platform for liver disease and how the fledgling drug company's early work mirrored that seen in diagnostics.
IGI Bets On Trispecific Antibody To Make Inroads Into Big Pharma Myeloma Turf
Ichnos Glenmark Innovation’s president and CEO talks to Scrip about the promising activity profile of the alliance’s early stage trispecific antibody versus Janssen’s teclistamab and also maintains that the setback for Gilead’s magrolimab hasn’t eclipsed prospects for its bispecific antibody.