Paragon 28 announced the launch of its sterile kit for allowing flexibility for surgeons and streamlining procedures in foot and ankle surgery. All components of the TenoTac soft tissue fixation system are now delivered in a neatly organized kit which can be provided on short notice. Paragon 28 expects the launch to expand accessibility to […]
Smith & Nephew issues urgent field safety notice for Profix mallet
Smith & Nephew (NYSE:SNN) initiated a field safety corrective action to update its Profix 750 grams mallet cleaning and sterilization guide after complaints regarding a potential failure mode associated with the use of the mallet, used in surgeries. Profix supplier Signal Medical received complaints regarding the failure mode in which the poly tip of the mallet may […]
TransEnterix slashes workforce amid disappointing Q3 results
TransEnterix (NYSE:TRXC) has let go of 39 employees, 18% of its headcount, as the robot-assisted surgery company turns its focus on existing Sehance system customers versus drumming up sales. “Our key areas of focus in 2020 will be on market develop activities, expanding the clinical economic evidence, supporting Senhance and adding important new features, such as […]
FDA puts Class I label on Zimmer Biomet’s Rosa Brain robot software recall
The FDA has given a recall on the Zimmer Biomet (NYSE:ZBH) Rosa Brain 3.0 devices for robot-assisted neurosurgery procedures a Class I designation, the most serious type of recall. Zimmer Biomet warned in September of the problem, in which a sequence workflow can trigger “a discrepancy between initial skin marking on the skull and instrument trajectory,” […]
5 ways medtech research aims to help veterans
As the United States prepares to honor its military veterans on Monday, medtech researchers are working to help survivors wounded in battle, both in body and mind. Whether the research comes out of government, industry or academia, there’s also a desire to help veterans facing other health challenges. Get the full story on our sister […]
Ethicon recalls Echelon Flex Endopath staplers
Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon yesterday issued a Class I recall of its Echelon Flex Endopath staplers after the product failed to completely form staples. Ethicon recalled the devices due to an out-of-specification component within the jaw of the stapler in some devices, which could lead to malformed staplers. If a problem isn’t recognized or addressed, […]
New study questions race, poverty as risk factors in knee surgeries
A new study observing the risk of total knee replacement revision or failure at a high-volume orthopedic hospital found that race and poverty were not significant factors in risk for knee replacement surgeries. Previous studies established that black patients have a higher risk for knee replacement revision and also report more pain and worse joint […]
BD warns of international device shortages in EO plant legal filing
The Georgia environmental chief’s effort to shut down a Becton Dickinson (NYSE:BDX) medtech sterilization plant could cause widespread shortages of commonly used devices for which BD has a large market share, the company said today in a court filing. On Tuesday, Georgia state Environmental Protection Division director Richard Dunn filed a motion with Newton County Superior Court […]
FDA clears GI Scientific’s duodenoscope ScopeSeal
GI Scientific said today that the FDA cleared its ScopeSeal duodenoscope protective device for protecting the distal end of a duodenoscope from contamination during endoscopic retrogade cholangio-pancreatography procedures. ScopeSeal is a single-use device designed to seal the infection-prone distal end of a duodenoscope by attaching to the end and reducing biomatter soiling during use. It […]
Auris Health touts FIH results for Monarch robot-assisted bronchoscopy device
Johnson & Johnson (NYSE:JNJ) subsidiary Auris Health said today that a study of its Monarch robot-assisted bronchoscopy device reached its primary effectiveness endpoint in nearly all procedures. The Benefit study assessed the platform’s ability to aid in the diagnosis of peripheral pulmonary lesions ranging from 1cm to 5cm. The Monarch platform localized targeted nodules using […]
Study: Most pro pitchers return to the rotation after elbow surgery
A study of professional baseball pitchers found that most returned to the sport without a significant decline after open reduction and internal fixation of the medial epicondyle. The study by Dr. Anthony Romeo and colleagues recorded demographic and performance data for 15 professional pitchers with a history of ulnar collateral ligament reconstruction (Tommy John surgery) […]
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