Negotiations for the sixth U.S. FDA device user fee agreement (MDUFA VI) are officially underway, and the Aug. 4 meeting highlighted some of the differences between the agency’s and industry’s expectations.
The FDA announced July 17 that Dexcom Inc. recalled a series of continuous glucose monitor receivers for a failure of speakers to issue an alert for out-of-specification blood glucose measures. This is a clear demonstration of the principle that greater device functionality often creates new types of risk.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Cardioprecision, Corcym, Evident, Inflammatix, Pramana, Quanterix, Transmedics.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alivedx, Roche.
While inflation in the U.S. is hovering below 3%, increases in some FDA user fees for fiscal 2026 are tripling that rate. PDUFA fees for branded prescription drugs and biological products will see a 9% hike come Oct. 1, and the increase in MDUFA fees will more than double the inflation rate with a 7% hike across the board.
Like waves crashing on the beach, med-tech IPOs keep on coming. Heartflow Inc. set terms for its IPO on Aug. 1, offering 12.5 million shares at a price range of $15 to $17 per share. At the top of the range, the company could raise a sunny $212.5 million. It plans to list on the Nasdaq with the symbol “HTFL.”
The U.S. Department of Justice announced July 31 that Illumina Inc. agreed to pay $9.8 million to settle allegations it sold genomic sequencing equipment that suffered from cybersecurity problems. The settlement concludes a qui tam lawsuit filed by a former employee and highlights the hazards of poor cybersecurity for med-tech firms.
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