The recent FDA advisory committee vote on Medtronic’s Symplicity Spyral device has sent shockwaves through the healthcare industry. While the panel unanimously voted in favor of the device’s safety, opinions were divided on its overall effectiveness and benefit/risk profile. These non-binding recommendations from the FDA often shape the agency’s decisions, although they are not legally binding.
Medtronic remains committed to working closely with the FDA to address concerns and further refine their innovative device. The clinical trial results have been a mix of successes and challenges, which will undoubtedly be taken into consideration moving forward.
In a concerning turn of events, this year’s updated Covid-19 vaccines are facing delays in reaching pharmacies. Despite the surge in Covid-19 cases across the nation, U.S. regulators anticipate the availability of these updated vaccines to be delayed until “mid-to-late September.” This setback raises concerns about effectively managing the ongoing pandemic.
On a more positive note, Questa Capital has successfully raised an impressive $397 million for their largest venture fund. This fund aims to support growth-stage healthcare companies, particularly those focused on connected medical devices and those advocating for value-based care. This significant investment demonstrates the continued interest and confidence in advancing healthcare technologies and systems.