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Home » Newsletters » BioWorld MedTech

BioWorld MedTech

Aug. 5, 2021

View Archived Issues
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FDA says PMA first cycle major deficiency rate approaching 21st century high

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

FDA greenlights Zoll’s newest Remedē system

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
British pound

4D Biomaterials raises £1.6M to develop soft tissue repair biopolymer

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
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Impact and Burning Rock team up to develop companion diagnostics for synthetic lethality drugs

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
Stethoscope and European flag

MDCG recommends formal implementation of UDI procedures in quality management system

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

Appointments and advancements for Aug. 5, 2021

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

Financings for Aug. 5, 2021

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

In the clinic for Aug. 5, 2021

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

Other news to note for Aug. 5, 2021

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 actions for Aug. 5, 2021

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

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