GE Healthcare has staked a major claim in a field that's not well tended--the development of affordable medical technologies to improve health outcomes in the emerging markets. It's creating a devoted business called Sustainable Healthcare Solutions out of a combination of its operations in India, South Asia, Africa and Southeast Asia dedicated to serving 70 markets--and investing $300 million to back the effort.
The Federal Trade Commission cracked down on Carrot Neurotechnology for making apparently unfounded claims that its Ultimeyes app is "scientifically shown to improve vision." The company agreed to stop making the statements, and disgorge $150,000 in profits.
The FDA notified the public of a Class 1 recall of SynCardia Systems' Total Artificial Heart, saying a specific part of the device known as the Freedom Driver that operates and monitors the heart could fail.
Bayer is facing disheartening news for its controversial birth control device Essure prior to an FDA panel meeting to discuss the product's safety, as new analysis by the agency shows a spike in reports from women who had bad reactions to the device.
Investors embraced the acquisition of the surgical robotics division of the Italian healthcare company SOFAR by minimally invasive surgical robot company TransEnterix. The deal is for up to $99.8 million in cash and stock to gain SOFAR's Telelap ALF-X robotic system for minimally invasive surgery.
The NIH funded GreatLakes NeuroTechnologies' deep brain stimulator for Parkinson's disease to the tune of $1.9 million.
Last year, Biogen brought on Adriana Karaboutis as its executive VP of technology to lead the company's med tech R&D push and further CEO George Scangos' vision of the company becoming a lead digital health player. And Karaboutis has not wasted any time since coming aboard, rolling out a series of new initiatives to bolster Biogen's recent efforts in the field.
St. Jude Medical has received a CE mark for its latest neuromodulation technology--the Infinity Deep Brain Stimulation System to treat movement disorders. It expects to get sign-off from the FDA and to launch the system in the U.S. before year's end. The franchise is the latest addition to St. Jude's neuromodulation business, which last quarter grew faster than the company's other groups in cardiac rhythm management, atrial fibrillation and cardiovascular.
Veran Medical Technologies has won $30.6 million in venture financing to back its early lung cancer diagnostic and therapeutic device. The news comes just as industry giant Medtronic has launched a post-market, observational trial of its own early lung cancer diagnostic system.
Cogentix Medical has raised a $7 million line of credit from Venture Bank to back sales growth for its disposable endoscope cover EndoSheath as well as its percutaneous tibial nerve stimulation for the office-based treatment of overactive bladder, the Urgent PC Neuromodulation System.
The FDA's device arm (CDRH) announced the launch of the Patient Engagement Advisory Committee to provide additional perspective on topics like patient preference information, risk-benefit determinations and device labeling. The move is an attempt to ensure that the actual users of devices can influence decision-making, in addition to industry and the medical community.
As superbug outbreaks at U.S. hospitals reach new heights, germ-fighting heavyweight Clorox Healthcare is rolling out an innovative UV cleaning device for drug-resistant infections at healthcare facilities.
Samsung has picked the three winners in its Solve For Tomorrow competition. All of them are healthcare devices; those selected share a prize of about $14,000 and get an opportunity to work with Samsung to further develop their products.
Two med tech execs are pushing back at the FDA's regulation of device marketing, claiming that the agency violated their constitutional right to free speech by restricting off-label marketing for certain products.
University of Cambridge researchers found that in a pair of similar studies, one in children and adolescents and the other in adults, that an artificial pancreas works better to control blood glucose levels in Type 1 diabetics than self-administration of insulin based on continuous glucose monitor (CGM) data.
The NBA is funding a study of wearable sensors to be performed at the Mayo Clinic. It will test devices from market leaders Catapult and STATSports.
Amputees are pushing back against a proposal to make Medicare reimbursement for prosthetic limbs and other durable medical equipment stricter, as the feds try to limit unnecessary payments, which amounted to $43 million in 2009.
National Institute of Mental Health Director Dr. Tom Insel will soon leave the government sector to work at Google's life sciences team, dubbed Alphabet. In an interview with Fortune, he made it clear he's bullish on med tech.
Analogic is moving some of its manufacturing to an existing facility in Shanghai, China, from Peabody, MA, and is trimming its R&D staff in its security business. All told, the reduction in force will hit 90 employees from the Peabody facility.
Medtronic launched the Arc support catheter, enabling faster delivery of the Solitaire Stent retriever to treat ischemic stroke patients by physically removing the clot and restoring blood flow in the brain's arteries.