The European Commission’s Medical Device Coordination Group has posted several guidances for unique device identifiers (UDIs), the most recent of which is related to a company’s quality management system. While most regulators have developed policies related to UDIs, this MDCG guidance recommends that device makers formally incorporate those requirements into their QMS programs, and that notified bodies will examine the manufacturer’s compliance with these requirements during inspections.
Zoll Medical Corp. has released its Remedē EL-X system for the treatment of central sleep apnea in adults, following the receipt of FDA approval. The next-generation implantable neurostimulation device will be rolled out in a phased launch in implanting centers in the U.S.
The FDA’s quarterly report on device user fee performance goals encodes a number of metrics, such as the rate at which PMA originals are cited for a major deficiency on the first review cycle. For premarket approval applications (PMAs) filed in fiscal year 2021 to date, the major deficiency rate on the first cycle is 86%, which would be tied for the fifth highest rate in two decades if that rate holds throughout the balance of the fiscal year.
Burning Rock Biotech Ltd. has formed a global strategic partnership with Impact Therapeutics Inc. to develop companion diagnostics for a pipeline of drugs in the field of synthetic lethality.
LONDON – Birmingham University spinout 4D Biomaterials Ltd. has raised initial funding of £1.6 million (US$2.2 million) to commercialize a new shape-changing biopolymer for use in soft tissue repair.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Insightrx, Ortho Clinical, Pillar, Zoll.
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