In a new study in the BMJ, researchers analyzed the Food and Drug Administration database where manufactures report adverse events and found that a huge number of reports come in late. Manufacturers are required to report issues within 30 days of finding out about them. Of 4.4 million manufacturer reports between 2019 and 2022, about 600,000, or nearly 14% came in late. Over 600,000 came in with missing or invalid dates. Notably, 1,004 deaths were reported late. The authors tease out a number of interesting nuances to how reporting happens. For example, late reports were disproportionately released in batches by manufacturers, which the authors suggest “could stem from manufacturers knowingly withholding important safety information from the public.” The authors also concede it might just take time to verify reports. They also name the top 10 late reporters (see above).

Most medical devices in the United States come to market with limited clinical data, and device surveillance is viewed as a key way to keep patients safe. But the FDA’s system for collecting data and keeping tabs on medical devices on the market has been shown to fall short, for example in the case of Philips’ faulty CPAP machines. 

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IndustryApple and Parkinson’s techRune Labs, which has for several years been building a Parkinson’s tracking solution for care and clinical trials around the Apple Watch announced a new subscription service including human coaching and monitoring for risk of falls and complications. Rune partners like Kaiser already use a very similar solution and this gives anyone who can afford it access. Its costs $600 a year. Also Parkinson’s related: MedRhythms, maker of a system that uses sensors and music to support gait rehabilitation announced a Food and Drug Administration listing for Movive, a new trade name for the system specific for Parkinson’s disease. Movive is listed as a 510(k) exempt biofeedback device meaning it has not been evaluated for safety and efficacy, and it is not cleared or approved by the regulator. MedRhythms cannot make treatment claims based on this listing, but it does allow the company to pursue reimbursement as durable medical equipment, which it has successfully done for InTandem, a similar system for stroke rehabilitation.After a years-long legal battle between device maker AliveCor and Apple over heart-monitoring technology used in the Apple Watch, a federal appeals court upheld an earlier ruling that AliveCor patents were invalid. In 2021, AliveCor alleged at the International Trade Commission that Apple copied its technology for monitoring for signs of heart problems. The ITC in 2022 agreed but in a parallel case, Apple managed to invalidate the patents with a U.S. patent office tribunal, so the ITC suspended an import ban on affected Apple Watches pending appeal. With the appeal lost, AliveCor is running out of room to navigate.