ALR Technologies Inc. (OTC:ALRT) landed FDA clearance for its Health-e-Connect System for diabetes management programs.
The web-based patient management platform allows doctors to remote monitor diabetic patients, a system that could result in significant savings to the the U.S. health care system through enhanced adherence to care plans, according to ALRT.
"The HeC system represents a breakthrough for clinician/patient communication to enhance disease management and improve health outcomes," said CEO Sidney Chan in prepared remarks.
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"A first-to-market product, the HeC system bridges gaps in current remote monitoring systems in a manner that is efficient, effective and affordable," added ALR Technologies President Lawrence Weinstein. "This FDA clearance is a major stride in our commitment to building long-term shareholder value as there is a wide spectrum of chronic diseases which the HeC platform can be deployed to improve outcomes and contain costs."
The 510(k) clearance allows the Atlanta, Ga.-based company to start its sales launch of its Health-e-Connect platform, which it plans to expand in 2012.
Presbia received medical device registration approval in Brazil for its Flexivue Microlens inlay treatment for presbyopia.
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Delcath Systems completed the product notification in New Zealand for its Delcath Hepatic Chemostat delivery system.
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Bedford, Mass.-based Hologic Inc. won FDA clearance for its proprietary direct digital detector technology to produce high quality images for rapid verification of tissue samples.
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Refractive lens-maker Staar Surgical
received word from Japan’s Pharmaceuticals and Medical Device Agency that its Toric implantable collamer lens will not need to go before the approval committee.
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Irish med-tech maker Crospon received FDA clearance for its EF-800 external channel endoscopic accessory.
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Vention Medical announced that the FDA completed the audit of its Costa Rican facility successfully with no inspectional observations issued.
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Sorin Group’s SonR sensor based cardiac resynchronization therapy optimization system lands CE Mark approval.
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Kelyniam Global won approval to sell its custom skull implants in veteran and military hospitals. The implant is used to correct of replace bony voids in the cranial skeleton caused by trauma or birth defects.
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Spineology Inc announced FDA clearance for its Rampart Interbody fusion implants for patients with spinal problems.
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The FDA has cleared Unisense FertiliTech’s EmbryoScope for clinical use in the United States.
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