The neurology community has amassed a great deal of evidence that a certain type of heart defect known as a PFO is associated with an increased risk of stroke. This finding has prompted companies with transcatheter devices developed for a niche pediatric congenital defect market to migrate to adult stroke prevention. In the new field, the risk isn't so much technical--a history of device use in the pediatric market has obviated alot of this risk--as clinical. In stroke prevention, clinical trials not only have to prove a negative, which is always difficult, but will also have to confirm the role of PFOs in stroke, as yet scientifically unproven, at the same time as they validate devices.
by Mary Stuart
A 37-year-old business traveler was arriving at his home airport after a seven-hour transatlantic flight. He stood up, strained to...
Join thousands of industry professionals who rely on Medtech Insight for daily insights
Already a subscriber?
Ultrahuman seeks to “create an environment that aligns with our bodies" by linking environmental parameters collected by Ultrahuman Home to health physiology, measured by the Ultrahuman Ring Air.
While HistoSonics is awaiting the CE mark in Europe, it hit a major milestone by securing early limited market access in Great Britain under a Unmet Clinical Need Authorization (UCNA), bringing its noninvasive histotripsy treatment to patients with liver tumors.
Manufacturing shifts, financial planning, and supply chain changes are among the adjustments that medtech leaders are making to Trump-era tariffs. Medtech Insight’s review of first-quarter earnings calls reveals how firms are navigating the impact and uncertainty of evolving trade policies.
J&J's EMEA head of digital solutions, Julia Fishman, talks about the major hurdles in scaling digital innovation, tips for clinical adoption and what’s up next on J&J’s innovation road map. Robot-assisted surgery pioneer Ivo Broeders gives his perspective on the difficulties in clinical adoption.
The rallying cry to start as early as possible has become increasingly common in the world of medical device development. Innovation expert Dr. Stuart Grant challenges this conventional wisdom, asking: Is "sooner" truly better, or is there a smarter path to market for your medical device?
J&J's EMEA head of digital solutions, Julia Fishman, talks about the major hurdles in scaling digital innovation, tips for clinical adoption and what’s up next on J&J’s innovation road map. Robot-assisted surgery pioneer Ivo Broeders gives his perspective on the difficulties in clinical adoption.
The KINCISE 2 Surgical Automated System aims to “reduce the physical burden on surgeons compared to manual impaction in primary and revision hip and revision knee replacement procedures,” said J&J MedTech.
