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. Read More

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. Read More

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. Read More

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. Read More

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. Read More

New hires and promotions in the med-tech industry, including: Becton Dickinson & Co., BD, Glycomimetics, Sonendo. Read More

Med-tech firms raising money in public or private financings, including: Rapid Micro Biosystems, Rxsight, Scivita Medical. Read More

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aerin Medical. Read More

Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Arena Pharmaceuticals, Fluidigm, Intuitive Surgical, Nanovibronix, Second Genome, Ultivue, Viewmind, Vystar. Read More

Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Insightrx, Ortho Clinical, Pillar, Zoll. Read More