Medical Device and Diagnostic Industry (MD+DI)

From Cyber Criminals to Recalls: Inside Intuitive Surgical’s Newest Snag

Intuitive Surgical recalls 8mm SureForm 30 Gray Reload staplers after incomplete staple lines caused one death and four ...
MedTech Dive

Intuitive Surgical recalls stapler reloads over issue linked to patient death

The recall follows reports of incomplete staple lines in procedures using the company’s da Vinci surgical robots.
MassDevice

Intuitive warns on surgical stapler reloads with one death reported

The FDA today issued an early alert related to an issue with a surgical stapler reload made by Intuitive Surgical (Nasdaq: ...
Ohsonline.com

FDA Assessing Safety of Surgical Staples for Internal Use

The agency plans in the coming months to issue a draft guidance with labeling recommendations for manufacturers and to hold a public advisory committee meeting to discuss whether the current pathway ...
New Atlas

New microneedle skin graft patch outperforms surgical staples

You’ve gotta love those Pomphorhynchus laevis worms. Although the parasites may feed on fish by attaching themselves to the inside of the host animal’s intestines, they’ve also provided the ...
Becker's Hospital Review

Surgical staplers linked to 41,000 injury, malfunction reports, FDA says

The FDA is warning healthcare providers about the risk of serious injury, malfunction and death associated with surgical staplers and implantable surgical staples. Between January 2011 and March 2018, ...
Business Wire

Patients and Physicians Prefer Zip Surgical Skin Closure over Staples in First Head-to-Head Comparison of the Device versus Staples During Bilateral Knee Surgery

CAMPBELL, Calif. & DALLAS--(BUSINESS WIRE)--ZipLine® Medical, Inc. today announced results from the first study to assess Zip® Surgical Skin Closure versus surgical staples for closure in the same ...
Business Wire

Zip Surgical Skin Closure Demonstrates Superior Health Economics and Clinical Outcomes Compared to Surgical Staples in Two Recently Published Clinical Studies

CAMPBELL, Calif.--(BUSINESS WIRE)--ZipLine Medical, Inc. today announced publication of positive results from two significant clinical studies in two peer-reviewed journals demonstrating that use of ...
FierceBiotech

FDA tightens regulations, broadens oversight of surgical staplers, implantable staples

Makers of surgical staplers and the implantable staples they’re loaded with will now need to jump through extra hoops before their products can be used to divide, seal and connect internal tissues for ...