FDA Data Reveals Late Reporting of Medical Device Issues
A recent study published in the BMJ analyzed the Food and Drug Administration’s (FDA) database, revealing that a significant number of adverse event reports from medical device manufacturers are submitted late. Manufacturers are obligated to report these events within 30 days, but the study found considerable delays.
Between 2019 and 2022, the FDA collected approximately 4.4 million manufacturer reports. Of these, nearly 14%, or about 600,000, were filed late. Furthermore, over 600,000 reports contained missing or invalid dates. Concerningly, a total of 1,004 deaths were reported late.
The study’s authors observed several patterns in the late reporting. They noted that manufacturers disproportionately released late reports in batches, suggesting that companies “could [be] withholding important safety information from the public.” The authors also acknowledge that verifying reports can take time. They also identified the top 10 manufacturers with the worst records for late reporting.
With most medical devices entering the U.S. market with limited clinical data, device surveillance serves a crucial role in patient safety. However, the FDA’s system for collecting and monitoring information about medical devices on the market has been shown to have shortcomings, as highlighted by the issues with Philips’ faulty CPAP machines.
Senators Scrutinize Telehealth Platforms Over Pharma Deals
Senators are again focusing on possible financial connections between pharmaceutical giants Eli Lilly and Pfizer and the telehealth companies they’ve partnered with through direct-to-consumer platforms such as LillyDirect and PfizerForAll.
Senators Dick Durbin and three other lawmakers sent letters to UpScript Health, Form Health, 9amHealth, Thirty Madison’s Cove, and Populus Health. They requested detailed information about prescription volumes and potential incentives for providers, seeking to ascertain whether contracts could violate federal anti-kickback laws.
When questioned similarly in October, Pfizer and Eli Lilly denied that their telehealth platforms encourage or incentivize providers to prescribe specific drugs. The telehealth platforms themselves have echoed these statements. Despite the ongoing scrutiny, according to a new report from Katie Palmer, both drug companies are expanding their online platforms with new direct-to-consumer offerings.
Hinge Health Outlines IPO Plans
Virtual musculoskeletal care company Hinge Health recently announced its plans to go public. Reviewing the initial filing reveals two key points:
- Focus on Medicare: Hinge primarily sells its services to self-insured employers. However, the company continually emphasizes its expansion goals for Medicare Advantage (MA) and original Medicare and Medicaid market. Hinge notes that it has begun expansion in MA, with its pelvic health and fall prevention programs already in use in MA. They also mentioned they have managed to parlay success with partners that work with some of its customers into deals for their MA populations.
- Aggressive Automation: Hinge highlights its focus on automation, estimating that its platform reduced the number of human care team hours associated with traditional physical therapy by roughly 95% in 2024. This automation includes a computer vision system for supervising exercise sessions and the utilization of AI for care team support. This automation strategy is similar to that described by Virgílio Bento, CEO of Hinge competitor Sword, who described own his “AI care” vision.
Apple and Parkinson’s Tech
Rune Labs, known for developing a Parkinson’s tracking solution for the Apple Watch used for care and clinical trials, has introduced a new subscription service. This service includes human coaching and monitoring for fall risk and complications. The service is priced at $600 annually. Rune partners such as Kaiser already offer a similar service, giving broader access to the technology.
In other Parkinson’s news, MedRhythms, a company that uses sensors and music for gait rehabilitation, announced an FDA listing for Movive, a new brand name for their system designed specifically for Parkinson’s disease. Movive is listed as a 510(k) exempt biofeedback device, which means its safety and efficacy have not been evaluated or cleared by the regulator. While MedRhythms cannot make treatment claims based on this listing, 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.
AliveCor Loses Apple Patent Appeal
After a lengthy legal dispute between device maker AliveCor and Apple over heart-monitoring technology in the Apple Watch, a federal appeals court upheld an earlier decision that invalidated AliveCor’s patents. In 2021, AliveCor claimed that Apple infringed on its technology for heart monitoring at the International Trade Commission (ITC). The ITC agreed in 2022, but in a parallel case, Apple successfully invalidated the patents with a U.S. patent office tribunal. Consequently, the ITC suspended an import ban on affected Apple Watches pending appeal. With the most recent appeal lost, AliveCor is running out of options.
