Health Tech Newsletter Highlights: Regulatory Lapses, Financial Scrutiny, and Market Moves
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FDA Device Reporting: Delays and Data Gaps
A recent BMJ study has revealed a significant issue within the Food and Drug Administration’s (FDA) database, where manufacturers report adverse events related to medical devices. The analysis showed that a substantial number of these reports are submitted late, exceeding the required 30-day timeframe. From 2019 to 2022, manufacturers filed approximately 4.4 million reports, with almost 600,000—nearly 14%—submitted late. Additionally, over 600,000 reports contained missing or invalid dates. Alarmingly, 1,004 deaths were reported late.
The study’s authors point out several interesting aspects of this reporting issue. For instance, a disproportionate number of late reports were submitted in batches by manufacturers. The authors suggest this could indicate that companies may be intentionally withholding critical safety information from the public. However, the researchers also acknowledge that verifying reports can be time-consuming.
Most medical devices in the United States enter the market with limited clinical data, making device surveillance a crucial measure to safeguard patient safety. However, the FDA’s current system for gathering and monitoring medical devices on the market has proven to be inadequate, as was seen in the issues with Philips’ faulty CPAP machines.
Telehealth Platforms Under Congressional Scrutiny
Senators are once again examining the financial relationships between major pharmaceutical companies, Eli Lilly and Pfizer, and the telehealth companies they link to through direct-to-consumer platforms like LillyDirect and PfizerForAll. Senator Dick Durbin and three other lawmakers sent letters to UpScript Health, Form Health, 9amHealth, Thirty Madison’s Cove, and Populus Health, seeking detailed information about prescription volumes and potential provider incentives. The focus is on determining whether these contracts violate the federal anti-kickback statute. Earlier, in response to similar questions in October, Pfizer and Eli Lilly stated that they do not encourage or incentivize providers to prescribe particular drugs, as have the telehealth platforms themselves.
Read more about Senator’s inquiries into the telehealth platforms.
Hinge Health’s IPO Filing: Automation and Medicare Expansion
The virtual musculoskeletal care company Hinge Health recently announced its plans for an initial public offering (IPO). Examining the filing reveals two notable strategies:
- Medicare Expansion: Hinge Health primarily serves self-insured employers. The company emphasizes its goal to expand into Medicare Advantage and, ultimately, into Medicare and Medicaid. The company indicates that is in the early stages of expansion into MA, with pelvic health and fall prevention programs already in use. The company notes success partnering with companies which have access to MA populations.
- Focus on Automation: Hinge Health highlights the potential of automation in healthcare, estimating that its platform reduced human care team hours associated with traditional physical therapy by approximately 95% based on 2024 data, a considerable efficiency gain. This is achieved through computer vision for exercise supervision and artificial intelligence (AI) assistance for care teams.
Apple and Parkinson’s Tech Developments
- Rune Labs is launching a new subscription service around Apple Watch-based Parkinson’s tracking. This will include human coaching and monitoring for fall risk and other complications. Rune Labs has partnered with Kaiser, and this new service adds human coaching and monitoring. The service costs $600 year.
- MedRhythms, a company that uses sensors and music to support gait rehabilitation, has been granted an FDA listing for Movive. Movive is a new name for their Parkinson’s-specific system. Being listed as a 510(k) exempt biofeedback, the company is not permitted to promote treatment claims based on this listing, but it does allow MedRhythms to pursue reimbursement as durable medical equipment, which they’ve successfully done for InTandem, a product for stroke rehabilitation.
Apple Wins AliveCor Patent Battle
A federal appeals court has upheld a ruling that invalidated AliveCor patents related to heart-monitoring technology used in the Apple Watch. AliveCor had claimed that Apple infringed upon its technology, leading to an import ban on affected Apple Watches pending appeal. Because of the latest ruling, AliveCor is running out of options to appeal the decision.
Additional Reading
- ‘Deliberate trauma’: SAMHSA employees detail a federal agency in shambles, STAT
- Epic CEO Judy Faulkner on AI, antitrust and consolidation, Modern Healthcare
