Medical device safety incidents are reported late

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In a brand new research within the BMJ, researchers analyzed the Meals and Drug Administration database the place manufactures report hostile occasions and located that an enormous variety of reviews are available in late. Producers are required to report points inside 30 days of discovering out about them. Of 4.4 million producer reviews between 2019 and 2022, about 600,000, or practically 14% got here in late. Over 600,000 got here in with lacking or invalid dates. Notably, 1,004 deaths have been reported late.

The authors tease out various attention-grabbing nuances to how reporting occurs. For instance, late reviews have been disproportionately launched in batches by producers, which the authors counsel “might stem from producers knowingly withholding vital security info from the general public.” The authors additionally concede it would simply take time to confirm reviews. Additionally they identify the highest 10 late reporters.

Most medical units in america come to market with restricted medical information, and machine surveillance is considered as a key technique to maintain sufferers protected. However the FDA’s system for amassing information and preserving tabs on medical units available on the market has been proven to fall quick, for instance within the case of Philips’ defective CPAP machines.

Telehealth platforms in senators’ crosshairs over pharma offers

Senators are once more questioning the monetary relationship between pharma giants Eli Lilly and Pfizer and the telehealth firms they hyperlink to from direct-to-consumer portals LillyDirect and PfizerForAll. In letters despatched to UpScript Well being, Kind Well being, 9amHealth, Thirty Madison’s Cove, and Populus Well being, Sen. Dick Durbin and three different lawmakers requested for detailed details about prescription volumes and attainable supplier incentives, aiming to find out if contracts might run afoul of the federal anti-kickback statute.

Pfizer and Eli Lilly, in response to comparable questions from the senators in October, stated that suppliers aren’t inspired or incentivized to prescribe particular medicine, because the telehealth platforms have additionally stated. In her new story, Katie Palmer writes that regardless of the scrutiny, the drug giants are solely rising their dedication to their on-line platforms with new direct-to- shopper choices. Learn extra right here

A number of particulars from Hinge’s IPO submitting

Earlier this week, digital musculoskeletal care firm Hinge Well being introduced its plans to go public. I spent a while wanting on the submitting, and two issues jumped out at me.

Medicare: Hinge primarily sells its companies to self-insured employers, or firms that pay the price of their employee’s well being care. All through the submitting, Hinge repeatedly notes its aim of increasing to Medicare Benefit and even to Medicare and Medicaid, pointing to the potential multi-billion greenback market alternative. The corporate notes that it’s within the early levels of increasing to MA and that its pelvic well being and fall prevention applications are being utilized in MA. Hinge additionally says that it managed to parlay success with companions that work with a few of its prospects into offers for his or her MA populations.

All-in on automation: It shouldn’t be all that shocking {that a} tech firm in 2025 is making an enormous deal concerning the alternative for automation. Even then, I used to be struck by Hinge’s estimate that, “based mostly on information from 2024, our platform lowered the variety of human care group hours related to conventional bodily remedy by roughly 95%.” Methods Hinge accomplishes this embrace utilizing a pc imaginative and prescient system to oversee train classes and utilizing AI to help care groups. Their aggressive stance on automation jogs my memory very a lot of what Virgílio Bento, CEO of Sword, a Hinge competitor, advised me a number of weeks in the past about his personal imaginative and prescient for “AI care.”

Apple and Parkinson’s tech

Rune Labs, which has for a number of years been constructing a Parkinson’s monitoring resolution for care and medical trials across the Apple Watch introduced a brand new subscription service together with human teaching and monitoring for threat of falls and problems. Rune companions like Kaiser already use a really comparable resolution and this offers anybody who can afford it entry. Its prices $600 a 12 months.

Additionally Parkinson’s associated: MedRhythms, maker of a system that makes use of sensors and music to help gait rehabilitation introduced a Meals and Drug Administration itemizing for Movive, a brand new commerce identify for the system particular for Parkinson’s illness. Movive is listed as a 510(okay) exempt biofeedback machine that means it has not been evaluated for security and efficacy, and it’s not cleared or permitted by the regulator. MedRhythms can not make therapy claims based mostly on this itemizing, however it does permit the corporate to pursue reimbursement as sturdy medical gear, which it has efficiently finished for InTandem, the same system for stroke rehabilitation.

After a years-long authorized battle between machine maker AliveCor and Apple over heart-monitoring know-how used within the Apple Watch, a federal appeals courtroom upheld an earlier ruling that AliveCor patents have been invalid. In 2021, AliveCor alleged on the Worldwide Commerce Fee that Apple copied its know-how for monitoring for indicators of coronary heart issues. The ITC in 2022 agreed however in a parallel case, Apple managed to invalidate the patents with a U.S. patent workplace tribunal, so the ITC suspended an import ban on affected Apple Watches pending attraction. With the attraction misplaced, AliveCor is working out of room to navigate.