Walgreens has issued beleaguered Theranos an ultimatum. The diagnostics company has 30 days to fix the violations of the so-called CLIA rules detailed in a letter from federal inspectors, or else the drugstore may sever their alliance altogether, cutting off Theranos from its main source of revenues and threatening its consumer-focused business model.
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.
Novartis has been riding a med tech wave lately, launching new projects to create digital and patient-monitoring devices. In its latest move, the company is working with tech giant Microsoft to develop an intelligent camera system for multiple sclerosis (MS).
Stryker announced a tuck-in acquisition, saying it has agreed to acquire all of the assets in Synergetics USA's neurology portfolio, which achieved sales of $31 million in 2015. The move will give the company access to at least two electrosurgical devices that are currently distributed by rival Johnson & Johnson.
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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.
Illumina was right at the core of a plan unveiled in August 2014 by the U.K. government to map 100,000 human genomes by 2017. Its early role focused on whole genome sequencing, but now the genomics giant has also been tapped for bioinformatics as well.
Robotic surgery aspirant TransEnterix said it has raised $18 million under its equity sales facility since September 2015, as it seeks FDA clearance of its Surgibot System.
"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.
23andMe has concentrated on diversifying its offerings since falling out with the FDA over its genetic testing products a few years ago. Now the company is adding another chapter to its comeback story, striking a deal with big data company Celmatix to work on infertility testing.
Lantern aims to put mental health services and professionals at the patient's fingertips with its online and mobile programs in cognitive behavioral therapy. To help it do so, Pittsburgh-based healthcare provider and payer UPMC is leading a $17 million investment and it also will partner with the San Francisco-based startup to conduct pilot testing of its approach.
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Coming just a few days after the U.S. Pharmaceutical Research and Manufacturers of America (PhRMA) called laws in India governing intellectual property "weak," a report out from the subcontinent says the Indian Pharmaceutical Alliance (IPA) is making moves to assuage concerns from the U.S. Trade Representative over its IP laws.
While much of the news in recent months on warnings issued by the U.S. Food and Drug Administration centered on alerts issued to Indian pharmaceutical manfacturers, active pharmaceutical ingredient and drug manufacturers In China have also received their own set of alerts under the FDA's Form 483 regime, according to a report by the Regulatory Affairs Progessionals Society.