FDA clears Abbott’s wireless handheld testing system | Regulatory roundup

March 29, 2011 By MassDevice staff Leave a Comment

The FDA granted Abbott Laboratories (NYSE:ABT) 510(k) clearance for the wireless version of its i-STAT 1 point of care testing system.

Healthcare providers use the Abbott Park, Ill.-based company’s handheld i-STAT 1 device to transmit diagnostic test results from the patient directly to electronic health records where doctor can access the data.

"With wireless, physicians can receive immediate test information in the electronic medical record, enabling them to act quickly when a patient’s clinical status is rapidly changing," head of Abbott POC business Greg Arnsdorff said in prepared remarks.

Abbott said its 10-minute i-STAT cardiac troponin test cartridge, which gives emergency department staff the ability to test, transmit and treat potential heart attack patients from the bedside, is one example of the system’s POC capabilities for increasing the pace of care.

About 50,000 i-STAT devices are in use worldwide and they process about 100 million test cartridges a year, according to the company.

Here’s a roundup of companies announcing clearances and approvals from the Food & Drug Administration and foreign regulatory agencies. Check out MassDevice’s compilation of the latest regulatory news for additional clearances and approvals.

Carl Zeiss Meditec wins PMA for expanded laser treatments
Carl Zeiss Meditec Inc.’s MEL 80 Excimer Laser won pre-market approval from the FDA for the treatment of hyperopia. This new indication complements the existing FDA approved applications of the surgical laser for myopia and astigmatism.
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Access Scientific wins FDA clearance for Powerwand
Access Scientific Inc. received FDA 510(k) clearance for the Powerwand — an extended-dwell, power-injectable 3.1 inch IV catheter delivered by means of the wands’s Accelerated Seldinger Technique. The device is designed to "transform the in-patient experience, by allowing many if not most patients to have one and only one needlestick for vascular access throughout their hospitalization," according to the company.
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EnteroMedics wins CE Mark approval for Maestro RC system
EnteroMedics Inc. (NSDQ:ETRM) received CE Mark approval of its second generation Maestro RC System for the treatment of obesity using VBLOC vagal blocking therapy. The Maestro RC System, a pacemaker-like device, is designed to offer a patient-oriented obesity therapy that affects the physiology of hunger and fullness without forcing punitive, mechanical limits to lifestyle and diet, or requiring surgical alteration of the anatomy. The company plans to commercialize the Maestro RC System in Australia.
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Siemens Healthineers lands FDA clearance for two CT systems
Siemens Healthineers this week said it won FDA clearance for its Somatom go.Sim and Somtom go.Open Pro computed tomography systems. The CT systems are designed for radiation therapy planning and are members of the company’s Somatom go. platform of devices. Siemens Healthineers’ platform uses hardware and software components like patient marking lasers and automated quality… […]
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 who spend […]
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… […]