Grail hopes to launch its Galleri test in 2021 as a laboratory developed test and submit a PMA to the US FDA in 2023.
Liquid biopsy company GRAIL, Inc. filed with the US Securities and Exchange Commission to raise up to $100m in an initial public offering with plans to launch its multi-cancer early detection blood test, Galleri, in 2021 as a laboratory-developed test (LDT), the company announced on 9 September.
Morgan Stanley, Goldman Sachs & Co. LLC and BofA Securities will act as lead underwriting firms for the proposed offering,...
When a large medtech company sets up a venture fund, it typically invests in technologies that are adjacent to its pre-existing portfolio. Intuitive Surgical’s approach is different.
This week, Establishment Labs Holdings announced the FDA gave it premarket approval for Motiva breast implant, Cologuard lands FDA approval for Cologuard Plus and GE HealthCare gets FDA nod for a new imaging agent. The FDA announces another expansion for TAP into ophthalmology and radiology. The AAMI and CTA will join forces to develop standards for AI and ML-enabled health care products.
Spain has one of the highest incarceration rates in Europe, with 160 individuals imprisoned per 100,000 residents. In 2020, 43,494 people were incarcerated in facilities not managed by regional health authorities — essentially all regions except Catalonia, the Basque Country, and Navarra.
The medtech companies navigate tariffs through a mix of proactive manufacturing moves, financial planning and global supply chain adjustments. Medtech Insight combined comments from executives made during their first-quarter earning calls to get an industry pulse check on how the surge of tariffs im
This week, Establishment Labs Holdings announced the FDA gave it premarket approval for Motiva breast implant, Cologuard lands FDA approval for Cologuard Plus and GE HealthCare gets FDA nod for a new imaging agent. The FDA announces another expansion for TAP into ophthalmology and radiology. The AAMI and CTA will join forces to develop standards for AI and ML-enabled health care products.
