The 21st Century Cures Act promises to overhaul regulation of the medical device (and biopharma) industry if it passes the Senate. It just passed in the House of Representatives with a strong bipartisan majority. One of the main ways in which it would benefit the device industry is through the creation of a "breakthrough" pathway for critical medical devices.
The U.S. Food and Drug Administration has approved an option for patients who have trouble with the standard socket leg prosthetics that are typically used for those with above-the-knee amputation. The implantable prosthetic requires two surgeries, but it's intended to encourage prosthetic usage and to improve patient outcomes.
The China FDA has issued revised and final medical device classification rules set to go into effect at the start of next year. The final rules categorize the level of risk posed by devices by noting structural features, intended use, and whether they involve human contact.
After scoring FDA approval last week for its finger-stick herpes test and striking its first deal to provide its tests for a private insurer, Theranos is teaming up with a managed care provider to offer its tests to Medicaid patients and snagging a CLIA waiver from the FDA for its herpes testing system.
The U.S. Food and Drug Administration may have made it a bit easier for chronic pain patients to evaluate whether a spinal cord stimulator could be an effective treatment. For the first time, it's approved a wireless, external device from St. Jude Medical that can be manipulated via an Apple iPod touch, rather than a dedicated controller that's likely to be less intuitive to patients.
The FDA is planning to team up with tech giant Google to identify previously unknown side effects of meds.
Final trial results reported in April showed that the efficacy of GlaxoSmithKline's investigational malaria vaccine wanes over time. But the candidate, dubbed RTS,S or Mosquirix, is the furthest along in the quest for a vaccine and so, may win WHO and EMA approval as the first vaccine against malaria.
Early trends from India's first survey on multidrug-resistant tuberculosis showed a lower rate of infections than World Health Organization estimates in findings that will help shape the government's treatment focus, the Indian Express newspaper reports.
Japanese drugmaker Takeda is angling to win FDA approval for its lead cancer asset, an oral treatment for blood malignancies that is key to the company's future in oncology.
Shanghai will build a China FDA medicine evaluation center to speed drug approvals, CNTV said on its website, as part of efforts to keep and attract drug and device firms to the region.