The notoriously tight-fisted National Institute for Health and Care Excellence (NICE), which makes healthcare product payment decisions for the U.K. on what can be used in the country's National Health Service (NHS), has come out with a recommendation in support of the use of the MiniMed Paradigm Veo system from Medtronic. It's specifically for adults and children with Type 1 diabetes who have had disabling episodes of hypoglycemia even with continuous subcutaneous insulin infusion.
Usually in the news due to constant rumors of an impending takeover by Stryker, Smith & Nephew announced that it will distribute precision alignment surgery technology alongside its artificial knee implants under an agreement with Aliso Viejo, CA, startup OrthAlign.
Research is advancing rapidly to validate imaging and blood biomarkers that can easily identify concussions and other traumatic brain injuries on the battlefield, in the sports arena and in emergency care rooms. The FDA demonstrated that the issue is a top priority for it by setting up a public meeting on March 3 to address the scientific developments, regulatory challenges as well as big data standardization, sharing and analysis issues raised by the hunt for TBI biomarkers.
"Gamification" is the new buzzword in med tech. After all, playing games can make tasks fun and provide a source of motivation. In the latest example, the FDA cleared the Yugo Microsoft Kinect-based physical therapy system.
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Johnson & Johnson sees big things ahead for California's NeuroVision, so it's expanding its partnership with the company. The move gives NeuroVision a boost as it looks to grab a bigger piece of the market for its Alzheimer's eye-imaging diagnostic.
Cook Medical is recalling 17,827 single-lumen central venous catheters and pressure monitoring sets and trays because of concerns about catheter tip fracture and/or separation. The FDA posted the Bloomington, IN's company's recall on its website, an action it takes from time to time to publicize recalls that are critical to patient safety.
SI-Bone's iFuse Implant System is one state away from nationwide Medicare coverage. Medicare Administrative Contractor National Government Services has agreed to reimburse the spinal implant used to treat sacroiliac joint disruption and degenerative sacroiliitis via minimally invasive spinal fusion.
An alliance of for-profit companies and academia is supporting the GenomeAsia 100K project that seeks to do whole-genome sequencing on 100,000 people in South Asia. Now, startup MedGenome has said it will kick in $10 million toward the effort to become a founding member.
VC firms traditionally take a measured approach to med tech investing, but GV, formerly Google Ventures, is bucking the trend. The company is betting big on companies with innovative technologies despite potential regulatory obstacles.
Pfizer Consumer Healthcare announced the launch of joint health and wellness innovation program that will enable 10 med tech startups to utilize the San Francisco office of tech industry incubator Galvanize.
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Mumbai-based Sun Pharmaceutical Industries wants the U.S. FDA to re-inspect its troubled Halol plant between April and June after efforts at answering complaints from a leaky ceiling that were first noted in September 2014 and some of which were highlighted in a December 2015 warning letter as still pending.
India's Sun Pharmaceutical saw its sales in the U.S., its largest market, continue to fall as problems with a key plant in India have yet to be resolved. U.S. sales were off 11% to $486 million in the quarter ended Dec. 31, 2015, India's largest drugmaker reported today.