NuVasive (NSDQ:NUVA) today announced the first commercial cases involving its Pulse spine surgery automation platform. Drs. Michael Kachmann and Zachary Tempel from Mayfield Brain & Spine in Ohio, and Dr. Paul Holman from Houston Methodist Hospital in Texas performed the procedures. In the case of the Ohio doctors, it was an extreme lateral interbody fusion […]
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Alva Health stroke monitor wins MedTech Innovator startup prize
MedTech Innovator has awarded its $350,000 global startup competition grand prize to Alva Health, the developer of a wearable, real-time stroke monitor. The New Haven, Connecticut-based startup won the medical device accelerator competition after a vote yesterday by attendees of The MedTech Conference, organized by AdvaMed. Get the full story at our sister site, Medical […]
GE Healthcare unveils next-gen cardiac-dedicated nuclear scanner
GE Healthcare (NYSE:GE) today announced that it has launched its MyoSpect cardiac-dedicated nuclear scanner. Chicago-based GE Healthcare designed the scanner to have an extended field-of-view processing with a new automated workflow. It features the company’s Alcyone technology and a CZT module design for a view of cardiac anatomy and pathology. “Today, the need for healthcare innovation […]
Former Theranos lab director faces cross-examination, says he was source for Wall Street Journal uncoverings
Former Theranos lab director Adam Rosendorff took the stand for a second day at the Elizabeth Holmes federal fraud trial to face cross-examination from the defense. The lab director testified that he felt pressured by management to defend lab tests despite the inaccuracies, multiple media sources report. For example, in several email exchanges with Holmes’ […]
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 […]
FDA approves Transmedics’ OCS Liver preservation system
TransMedics (NSDQ:TMDX) today announced that it has received FDA premarket approval for its OCS Liver system for use with organs from donors after brain death and circulatory death. Andover, Massachusetts–based Transmedics designed the device to preserve and monitor the hemodynamics and metabolic function. It allows for ex-vivo assessment of liver allografts from brain dead and circulatory […]
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 […]
Pfizer and BioNTech submit initial data to FDA on its COVID-19 vaccine and younger children
Pfizer (NYSE:PFE) and BioNTech (NSDQ: BNTX) plan to formally seek FDA emergency authorization in the coming weeks for the use of their Comirnaty (BNT162b2) vaccine in children 5 to 11. The news came today as the companies announced the submission of initial Phase 2/3 trial data to FDA. The companies last week announced that the […]