AdvaMed this week honored former BD CEO Edward Ludwig with its 2021 AdvaMed Lifetime Achievement Award. Ludwig received the award on September 27 during an in-person and live-streamed event as part of The MedTech Conference. Ludwig joined BD in 1979 and rose through the ranks to eventually become chair and CEO, retiring from the company in […]
FDA clears Caretaker Medical’s next-gen noninvasive blood pressure monitoring platform
Caretaker Medical (Charlottesville, Virginia) has secured FDA clearance for its next-generation VitalStream wireless blood pressure and hemodynamic monitoring platform, the company said today. The VitalStream wireless platform expands on the previously cleared Caretaker4 wireless patient monitor. The platform, according to the company, can measure blood pressure and hemodynamic parameters with every heartbeat. The result is […]
Boston Scientific to invest more than $30M in Irish facility
Boston Scientific (NYSE:BSX) will invest €30 million (about $34 million) in its Cork, Ireland facility, the Irish government announced today. The Irish government supported the research, development and innovation (RD&I) investment through IDA Ireland. The money will go toward accelerating the development and manufacturing of minimally-invasive medical technologies that treat patients suffering from cancer and […]
LumiraDx goes public as SPAC deal closes
LumiraDx shares are trading at more than $8 apiece on the Nasdaq today under the symbol LMDX after the company completed its merger with a SPAC called CA Healthcare Acquisition Corp. The point of care diagnostic testing company has a pipeline of more than 30 assays across common health conditions, including infectious diseases, cardiovascular diseases, […]
Abbott wins FDA approval for next-gen Amplatzer Talisman
Abbott (NYSE:ABT) announced today that the FDA has approved its Amplatzer Talisman PFO occlusion system for stroke prevention. In addition, the FDA cleared the Amplatzer Talisman delivery sheath. The Amplatzer Talisman is a next-generation version of the company’s Amplatzer PFO occluder, originally approved in 2016. The Talisman has an additional 30 mm device size, and […]
CDRH’s Shuren says they’re ‘starting to turn the corner’ from COVID-19
Medical device industry insiders will have to wait until the new year to get a better idea of the post-pandemic priorities at the FDA’s CDRH. That was one of the big takeaways from Dr. Jeff Shuren’s remarks at the virtual CDRH Town Hall held yesterday at AdvaMed’s The MedTech Conference, which takes place this week as a […]
FDA clears Koya Medical’s active compression therapy on the go
Koya Medical said today that it has won FDA 510(k) clearance for its Dayspring Lite treatment for lymphedema and venous disease. The Oakland, California–based company’s Dayspring family of treatments enables people to be mobile during active compression therapy — unlike traditional wall-tethered compression pumps. Dayspring Lite is a prescription-only treatment for people who need basic […]
GE Healthcare launches next-gen fixed X-ray system
GE Healthcare (NYSE: GE) today announced its next-gen Definium Tempo fixed X-ray system. The Definium Tempo is a fixed, overhead tube suspension (OTS) digital X-ray system. Its creators designed it to be a “personal assistant” to radiologists and technologists. The idea is to leverage automation to reduce workflow burdens and help radiology departments boost patient […]
Women may have more adverse events with left atrial appendage occlusion devices than men
Women appear more likely than men to experience adverse events or lengthened hospital stays from left atrial appendage occlusion (LAAO) devices, the FDA announced today. In a letter to health care providers, the FDA said researchers have yet to determine the reason for the difference — and that it is working with device makers to […]
The MedTech Conference by AdvaMed to be a mixture of in-person and virtual
To hold an event or not to hold a live event. Medtech trade association AdvaMed chose both for The Medtech Conference, which takes place next week. The September 27–30 conference includes a mixture of virtual presentations and in-person events in Washington, D.C., and Minneapolis. AdvaMed CEO Scott Whitaker mentioned several conference agenda highlights during a […]
Vicarious Surgical stock continues to rise
It’s so far, so good for Vicarious Surgical (NYSE:RBOT) during its first week of trading as a public company. The robotic surgery company’s shares were up more than 19% to $15.05 by midday today. During the company’s first day of trading yesterday, shares rose 2% to $12.60 apiece, even as the Dow Jones Industrial Average […]