FDA clears more Chocolate PTA balloon catheters | Regulatory Roundup

June 19, 2012 By MassDevice staff Leave a Comment

TriReme touts FDA okay for more Chocolate PTA balloon catheters
Pleasanton, Calif.-based vascular devices maker TriReme Medical won expanded FDA indication for additional sizes of its Chocolate percutaneous transluminal angioplasty balloon catheters.

"This latest regulatory approval broadening the available size matrix of the Chocolate PTA balloon marks yet another important milestone for TriReme Medical," president & CEO Eitan Konstantino said in prepared remarks. "There is more to come; our goal is to provide a broad range of innovative tools to improve outcomes in patients suffering from complex vascular disease."

TriReme initially won 510(k) clearance late last year for the Chocolate line of devices to treat occluded peripheral arteries.
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InTouch lands 510(k) win for remote cute care systems
Santa Barbara, Calif.-based InTouch Health won expanded FDA 510(k) clearance for a range of its telemedicine systems to enable active patient monitoring in environments where immediate clinical action may be required. The new clearance specifically targets surgical, cardiovascular, neurological, pre-natal, psychological and critical care monitoring, assessment and examination.
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Maquet wins CE mark for new anti-microbial vascular graft
Maquet Cardiovascular won CE Mark approval in the European Union for its Intergard Synergy vascular graft, made with anti-microbial compounds to prevent vascular graft infections.
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Sterigenics’ legal troubles mount in Illinois
Nearly two dozen new lawsuits were filed against Sterigenics this week over its now-shuttered ethylene oxide (EtO) sterilization plant in Willowbrook, Ill., according to a law firm representing some of the plaintiffs. That brings the total of such lawsuits to nearly 75, noted Chicago personal injury lawyer Antonio Romanucci, court-appointed lead counsel from among five… […]
In2Bones launches AlloAid BioNail
In2Bones this week launched its AlloAid BioNail sterile allograft implant. The implant is designed to give rigid, stable fixation during hand and foot reconstruction. AlloAid BioNail is made from strong cortical allografts to provide osteoconductive properties for bone remodeling and healing. It features a tapered point and multiple, contoured wedge facets to ease insertion, anchor… […]
Protolabs’ healthcare grant spurs 2 feeding tube inventions
Digital manufacturer Protolabs (NYSE:PRLB) announced today that MedStar Health (Columbia, Md.) and Cleveland Clinic Innovations are joint winners of the company’s Cool Idea Award: Healthcare Grant. These grants provide in-kind manufacturing services to the support development of medical products to spur innovation in the field. MedStar Health’s gravity-feed syringe holder simplifies the feeding of newborns… […]
Nihon Kohden launches new patient monitor
Nihon Kohden (TYO:6849) announced the U.S. launch of its Life Scope SVM-7200 series vital signs monitor for outpatient facilities and beds that aren’t continuously monitored. The Life Scope SVM-7200 is designed to provide customizable early warning scoring to help clinicians identify patients who are deteriorating or at risk of deterioration. It combines vital signs data with… […]
Senate confirms Dr. Stephen Hahn to lead FDA
The U.S. Senate has confirmed Dr. Stephen Hahn as the next commissioner of the FDA. The vote was 72 to 18, according to a report in the New York Times. Hahn will be the first permanent commissioner of the agency since Dr. Scott Gottlieb resigned in April. President Trump nominated Hahn, the chief medical officer at Houston’s… […]
3M to sell drug-delivery biz to Altaris Capital Partners for $650m
3M (NYSE:MMM) announced today that it entered into an agreement to sell most of its drug-delivery business to an affiliate of Altaris Capital Partners for approximately $650 million. St. Paul, Minn.-based 3M will retain its transdermal drug delivery components business, according to a news release. The business being divested has annual global sales reaching approximately… […]
Lawsuit endangers Sterigenics consent order in Georgia
A consent order that Sterigenics entered into with the state of Georgia to reduce ethylene oxide (EtO) emissions at its Atlanta medtech sterilization plant may be in jeopardy. A hearing is scheduled today on a lawsuit that accuses the Georgia Environmental Protection Division (EPD) of failing to take public comment before entering the Aug. 7… […]
Trelleborg acquires Tritec Seal
Trelleborg Sealing Solutions said today it has closed on its acquisition of rotary seal manufacturer Tritec Seal, which produces engineered polytetrafluoroethylene (PTFE) sealing solutions. Trelleborg said the acquisition strengthens its product portfolio while giving the business area access to increased manufacturing capacity. Headquartered in Fenton, Mich., with additional manufacturing in Giddings, Texas, Tritec Seal generated… […]
RSNA 2019: 7 radiology innovations you need to know
Nearly 53,000 people attended the 2019 Radiological Society of North America annual meeting in Chicago last week. And they heard the same acronym over and over again: AI. Exhibitors at the conference touted their artificial-intelligence-enhanced technology at every turn, claiming to make images clearer, sharper, easier to use and powerful enough to help clinicians make… […]
Employees say Intuitive Surgical, J&J, Stryker best places to work in 2020
Intuitive Surgical (NSDQ:ISRG), Johnson & Johnson (NYSE:JNJ) and Stryker (NYSE:SYK) were recently named as Glassdoor’s employees’s choice of Best Places to Work in 2020. Each year, Glassdoor uses feedback that employees have shared on the website over the past year to compile a list of the best places to work in 2020. Employee reviews provide Glassdoor with insights into job and… […]
Biolase lands 510(k) for dental hygiene laser
Biolase (NSDQ:BIOL) this week announced it has received FDA 510(k) clearance for its Epic Hygiene dental laser. The laser system allows dental hygienists to manage non-surgical periodontitis and increase clinical production. It offers a step-by-step clinical protocol with pocket therapy and perio debridement for easy implementation. Get the full story on our sister site, MassDevice. The […]