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.
Upstart Establishment gets $20M+ to bring safer breast implants with nanotech, RFID tracking to U.S.
Startup Establishment Labs has won more than $20 million in financing from private equity firms Crown Predator Holdings and JW Asset Management to market a next-gen breast implant that's supposed to be safer and more easily tracked.
Neurovascular device maker Penumbra will ring the opening bell on the New York Stock Exchange today, as it kicks off live as a public company with an upsized $120 million IPO--the device industry's biggest of the year. The company sold 4 million shares for $30, versus an expectation of 3.8 million shares for between $25 and $28.
The FDA is raising red flags about bronchoscope devices used in throat or airway procedures, pointing to infections linked to products that are not cleaned properly.
Researchers from the University of Southampton have created an ultrasonic device that creates tiny bubbles to scrub surfaces--thereby reducing the need for additives and heating to achieve effective cleaning. Known as the StarStream, the device, which is already in commercial production by ultrasound cleaning specialist Ultrawave, essentially improves the cleaning power of water.
A comprehensive survey of mobile health apps by IMS Health found that there are now more than 165,000 of them on the market.
The middle class in emerging market countries wants diagnostics--and Minneapolis, MN-based Ativa Medical plans to bring it to them via a point-of-care, micro lab designed for the physician office. The startup has secured a $15 million Series B round that's intended to support gaining FDA approval for its micro lab and preparing for commercial launch.
Philips CEO Frans van Houten downplayed expectations during the company's Capital Markets Day in London, saying that due to increasing macroeconomic risks in China and other emerging markets, he expects "moderate" sales growth in 2016.
A former St. Jude Medical exec is being charged with stealing hundreds of thousands of dollars from the company for personal expenses and running off with the devicemaker's trade secrets after his position was terminated, a sordid footnote for the company as it forges ahead with new technology and puts the finishing touches on its $3.4 billion deal for heart pump maker Thoratec.
Almost one year into the job, GE Healthcare President and CEO John Flannery recently outlined his strategy for returning the healthcare business to growth. It's an $18 billion business that accounts for about 16% of the conglomerate's total revenues. He affirmed that the business will remain within GE, despite ongoing restructuring involving the divestiture of the finance arm.
Zoll Medical amplified its focus on cardiac arrest patients with the acquisition of Israel's Kyma Medical Technologies for $35 million, plus milestone payments based on sales and the incorporation of Kyma technology into future products. The company makes a wearable remote patient monitoring device for congestive heart failure.
Amid growing scrutiny over the FDA's regulation of duodenoscope devices, the agency is calling for more stringent review of machines used to clean the products and companies that make the tools.
Dr. Robert Califf has been nominated as the next FDA commissioner. He became the deputy commissioner for medical products and tobacco in February.