From the Theranos case to wearable medical devices, it’s been another busy news week for the medical device industry.
Want to hear more about the week’s top news? Executive editor Chris Newmarker and Tom Salemi will discuss the week’s “Newmarker’s Newsmakers” during our DeviceTalks Weekly podcast. Without further ado, here’s this week’s MassDevice Top Five:
5. Bardy Diagnostics names new CEO
Kevin Hykes— who over the years has led companies including Relievant Medical Systems, Metavention and Cameron Health — will take over the corner office at Bardy Diagnostics. Bardy has developed the CAM (Carnation ambulatory monitor) for monitoring cardiac rhythms. Read the full story.
4. Drug companies say they won’t release COVID-19 vaccine until it’s ready
Executives from nine different drug companies announced a pledge to ensure safety with a potential COVID-19 vaccine. “We believe this pledge will help ensure public confidence in the rigorous scientific and regulatory process by which COVID-19 vaccines are evaluated and may ultimately be approved,” the statement concluded. Read the full story.
3. Theranica lands CE mark for migraine device
Theranica has t received CE Mark approval for its Nerivio device for the acute treatment of migraine. Montclair, N.J.-based Theranica adds European approval just over a year since it received FDA de novo clearance for the neurostimulation device in May 2019. Read the full story.
2. How the presidential election could affect medtech
No matter who ends up in the White House, there will need to be a reckoning over how the government’s relationship with medtech has changed, according to industry insiders. Read the full story.
1. Elizabeth Holmes could make a ‘mental disease’ defense in Theranos case
Former Theranos CEO Elizabeth Holmes is considering making a “mental disease” defense in her closely watched federal fraud trial in San Jose, Calif. A new court order revealed the defense strategy. Read the full story.