The U.S. FDA’s final guidance for premarket submissions for device software functions serves as a much needed overwrite of a badly outdated policy but includes some significant changes over the legacy guidance. There are also a few changes between the 2021 draft and the 2023 final guidance, however, such as a call for more details about how software anomalies were discovered and what a root cause analysis would suggest about the origin of the anomaly.
Trinity Biotech plc. received U.S. FDA 510(k) clearance for its lab-based hemoglobin diagnostic system, the Premier Resolution system, which the company hopes will allow it to regain its market leading position in hemoglobin variant detection. The Premier Resolution system is an automated analyzer which quantifies fetal hemoglobin and hemoglobin A2 and detects more than 200 hemoglobin variants. The device is a modern successor to the company’s Ultra system which once held a leading position in the U.S. hemoglobin variant diagnostic market.
In a balancing act between supply and drug quality, the U.S. FDA tipped the scales on behalf of quality, slapping an import alert on Intas Pharmaceuticals Ltd. in June, followed by a July 28 warning letter requiring the India-based company to develop and implement a global corrective action and preventive action plan.
Three former employees of Bose Corp. are banking on their audio experience and Ozlo Sleepbuds helping the millions of people who struggle to sleep soundly each night. That prospect is music to the ears of investors Lifearc Ventures and Artis Ventures, who led Ozlo Sleep Inc.’s $10 million round to bring the wireless, in-ear headphones to market in the next few weeks.
The debate in the U.S. over the process by which the Medicare program covers new medical technologies has intensified over the past three years and the debate has now spilled onto the pages of the Journal of the American Medical Association. An article in JAMA asserts that only 44% of a group of 64 novel devices had achieved meaningful coverage and reimbursement milestones within a median of 5.7 years after FDA market authorization, adding yet more pressure on the legislative and executive branches to act to deal with what device makers characterize as the med-tech valley of death.
An estimated 10% to 20% of adolescents worldwide struggle with mental health issues. According to the CDC’s most recent Youth Risk Behavior Survey, nearly 60% of teen girls in the U.S. reported feeling sad every day for at least two weeks in the previous year and 22% of high school students considered taking their own lives. Yet despite these trends, the majority of mental health conditions in young people go undiagnosed and untreated.
The proposed $875 million acquisition of Cook Medical Inc.’s reproductive health business by the Coopercompanies Inc. has been scotched, a development lauded by the U.S. Federal Trade Commission in a statement describing the proposed transaction as anticompetitive. However, the FTC statement also pointed to cooperation from authorities in both the U.K. and Australia as critical in forcing the abandonment of the transaction, a signal that such cooperation is likely to grow in the future.
Even as biopharma challenges to the constitutionality of the “excise tax” included in the Inflation Reduction Act await action in the U.S. federal court system, the Treasury Department and the Internal Revenue Service (IRS) said they intend to issue proposed regulations to implement the tax.
Despite the U.S. FDA’s approval of Sage Therapeutics Inc.’s priority NDA for postpartum depression, the accompanying complete response letter (CRL) for major depressive disorder has undercut the company’s plans. Withholding the approval for MDD slices away a huge amount of the potential market for Sage and its collaborator, Biogen Inc.
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