Several companies formed in the 1990's are poised to validate the clinical potential of light-based diagnostics as they guide through clinical trials products for a wide variety of applications in cancer, dermatology, gastrointestinal and cardiovascular diseases. Developers of the new optical imaging technologies ultimately hope to improve the way physicians diagnose diseases, by enabling insight into conditions where detection is currently inadequate. They hope to improve outcomes by detecting diseases at earlier stages, before pathological changes become visible. Finally, they aim to develop non-invasive systems that offer rapid diagnosis at the point of care, so that physicians can see and treat patients in a single visit. For now, though, companies are approaching the market cautiously. Most have a strategy of getting their products approved for adjunctive applications rather than attempting to win approval for the devices as standalone diagnostic systems that replace current screening methods.
by Mary Stuart
For years, researchers have known that tissues with different
physical properties respond in distinctive ways to light directed
at them, and that these responses can potentially be measured to
discriminate between diseased and normal tissue. But until
recently, there was a technological gap between the fantasy of
novel non-invasive diagnostic technologies and the reality of
robust technologies with commercial potential. Now, the
telecommunications industry is providing the missing links.
Fiberoptics developed to carry information in the form of light for
communications have begun to revolutionize medicine as well
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on Medtech Insight for daily insights
Moves are at last underway for a more specific focus on orphan and pediatric devices. They are a start; but experts are calling for more to support this sector.
Post-market surveillance regulations for medtech system users in Great Britain coming into force on 16 June will make new data requirements under new compliance deadlines.
HHS Secretary Robert F. Kennedy, Jr. is asking the public to help cut waste across the government’s health agencies. Kennedy announced a 60-day comment period allowing the public to take part in a broader federal initiative to reduce regulations and increase transparency.
The intricate assembly of medical devices, often involving over 1,000 globally sourced components, faces severe disruption due to new US tariffs. These barriers could halt production and devastate small and medium-sized enterprises (SMEs), MedTech Europe’s CEO, Oliver Bisazza, warns in an interview with Medtech Insight.
Health and Human Services Secretary Robert F. Kennedy Jr. emphasized administrative cost reductions and defended budget decisions during a Senate hearing on HHS funding. Some senators, however, expressed concerns over the impacts spending cuts had on essential health programs.
During his testimony before US senators on the impact of tariffs on critical supply chains, AdvaMed’s Scott Whitaker said the Trump tariffs could jeopardize America’s preeminence in medtech. Other industry experts echoed similar concerns.
In Vivo spoke to the previous commissioner of the US FDA about recent ongoings at the agency, and where he believes policy should be directed for patient and industry benefit.
