The IEC has made a change to the Recovery Test, 60601-2-34. Issue 3 offers modifications that make it more beneficial for engineers as a custom test system is no longer required for this specific test. This article reviews the full breadth of the test and how it can impact medical device manufacturers.
Encouraging compliance is a critically important—and often overlooked—aspect of a product’s design. Compliance is relegated to a discussion between patient and caregiver, but I believe the device should play an active role. First, the user experience must be friendly.
San Diego respiratory devices maker ResMed filed a new complaint with the International Trade Commission, this time against Chinese medtech company BMC Medical Co. and its U.S. subsidiary 3B Products. ResMed had previously filed a lawsuit against BMC and 3B, accusing the duo of infringing on patents for CPAP devices, a nasal mask and a nasal pillow interface.
Reflectance Medical Receives FDA Clearance for Mobile Careguide™ 3100 With The First-ever Noninvasive pH SensorJuly 22, 2013 12:22 pm | by PR Newswire | News | Comments
Reflectance Medical, a developer of innovative noninvasive medical sensors, announced today that it received 510(k) clearance for the battery-powered Multi-Parameter Mobile CareGuide™ 3100 which simultaneously and continually measures muscle oxygen saturation (SmO2) and pH (pHm).
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Cook Medical launched a new treatment option today for rhinologists who treat patients that suffer from difficult-to-heal conditions in the nasal passages. The Biodesign ENT Repair Graft acts as an adjunct to aid in the natural healing process following nasal and sinus mucosal surgery.
Severe damage to the large vessels from multiple trauma or accidental complications in surgery can cause exsanguinating hemorrhage leading to death. Especially in the thin-walled vena cava abundant with blood, a tear in a small laceration soon widens, requiring a difficult and specialized vascular surgery technique to be fixed.
Pennsylvania medical device maker ALung Technologies is nearing the close of a $17 million equity funding round with about $14.7 million raised so far among 48 unnamed investors, according to an SEC filings. The new report updated a fundraising effort that began in late March 2013, and ALung reported last month that it had hit the $9.5 million mark in the raise.
Multiple sclerosis treatments that repair damage to the brain could be developed thanks to new research. A study has shed light on how cells are able to regenerate protective sheaths around nerve fibres in the brain. These sheaths, made up of a substance called myelin, are critical for the quick transmission of nerve signals, enabling vision, sensation and movement.
If you squeeze a normal object in all directions, it shrinks in all directions. But a few strange materials will actually grow in one dimension when compressed. A team of chemists has now discovered a structure that takes this property to a new level, expanding more dramatically under pressure than any other known material. The finding could lead to new kinds of pressure sensors and artificial muscles.
Ohio-based Minimally Invasive Devices capped an $11.5 million Series B funding round with a final $2.5 million investment from Radius Ventures, according to a company statement. MID said it's putting the new cash into marketing and sales for its FDA-cleared device for laparoscopic surgeons, the FloShield vision system.
A new milestone by engineers at the University of California, Berkeley, can help robots become more touchy-feely, literally. A research team led by Ali Javey, UC Berkeley associate professor of electrical engineering and computer sciences, has created the first user-interactive sensor network on flexible plastic.
MicroVention Announces First Trial Enrollment In Their U.S. Clinical Trial Of Its New Dual-Layer Stent For Cerebral Aneurysm Flow DiversionJuly 22, 2013 10:00 am | by The Associated Press | News | Comments
MicroVention, Inc., a wholly owned subsidiary of Terumo Corporation, announced earlier last week that they successfully completed their first enrollment in a multi-center, prospective, pivotal U.S. clinical trial to demonstrate the safety and efficacy of its FREDT flow diversion system (FREDT-Flow Re-Direction Endoluminal Device) for treating intracranial aneurysms.
San Diego sleep and respiratory medical devices maker ResMed notched a win, of sorts, against Taiwan's Apex Medical after the International Trade Commission ordered a consent decree banning Apex from importing into the U.S. products that infringe on ResMed's patents.
IPG, the leading nationwide provider of Implantable Device Benefit Management (DBM) solutions, was named a recipient of the 2013 CIO 100. The 26th annual award program recognizes organizations around the world that exemplify the highest level of operational and strategic excellence in information technology (IT).