A rising tide lifts all boats--that might be the most oft-repeated cliché to sum up market sentiment in the life sciences for the last few years. Biotech performance has been very, very good for three years, and med tech performance, while nowhere near as stellar, has been on its own upward trajectory as investors look for a safer way to make money in healthcare.
NeoTract touted study results in the official journal of The American Urological Association that the company claims show that its UroLift device enabling minimally invasive treatment for an enlarged prostate is safe and effective.
At least a half-dozen med tech companies are ready for an IPO in the coming weeks. Already, they have either set IPO terms or have launched on to an IPO road show to sell investors. The three that have set rough IPO dates all have done so for the end of January.
Zimmer is spending €51 million to create a new orthopedics manufacturing facility in Galway, Ireland, that will result in 250 new jobs over the next 5 years. The facility will also host an education facility for doctors. Zimmer currently employs 350 people in Ireland.
Apple has growing med tech ambitions, but those gnarly healthcare regulations have left a sour taste in its mouth. As a result, the Silicon Valley bigwig has stepped up its engagement with the feds, seeking not only to learn by meeting with the FDA but also to change the rules via a lobbying effort that cost nearly $3 million last year.
EarlySense has gained $20 million in financing to support its work to help bring smart sensors and analysis to patient monitoring in healthcare institutions as well as in the home. Strategic investor Samsung Ventures led the round with a $10 million commitment.
Johnson & Johnson is working to make its medical device business grow as fast as the pharmaceutical side--but for now devices sales growth is slowing, while pharma is picking up fast.
The FDA said in a draft guidance issued last week that it does not intend to regulate general wellness products, which include an array of consumer-oriented wearables like Fitbit's exercise trackers.
France's Carmat reached another milestone in its quest to bring its artificial heart to market, as a patient who received the device in August has recovered enough to return home.
The advent of 3-D printing in the medical device arena has opened up new dimensions for its uses, with developers conjuring up new ideas on an almost weekly basis.
India's medical device industry will officially open Jan. 21 to unlimited foreign direct investment as the government kicks off what is expected to be a year of vast changes in the way it regulates the products.
Dozens of angry patients who claim they were injured by LASIK eye surgeries are banding together in an attempt to pressure the FDA to crack down on providers of the therapy.
Philips announced that it will share anonymized data on more than 100,000 patients collected via its Hospital to Home eICU telehealth initiative with the Massachusetts Institute of Technology.
As med tech companies home in on next-generation devices for diabetes, researchers are developing a noninvasive temporary tattoo that can monitor glucose levels through the skin.
The Medical Testing Availability Act of 2015 would restrict the ability of the FDA to enforce tacit marketing of "research use only" diagnostics for clinical purposes. The bill is sponsored by Rep. Michael Burgess (R-TX), who is also spearheading opposition on Capitol Hill to FDA's plans to regulate laboratory-developed tests.
The FDA and the Centers for Disease Control and Prevention are investigating the possible death of one patient and illnesses in more than a dozen others across 7 states after several hundred bags of IV solution meant for training healthcare workers ended up being used on more than 40 patients.
Med tech venture investing may lag biotech by more than half, but it's coming on strong. As venture-backed exits pick up, a real devotion to breakthrough innovation seems to be whetting investor appetites. A total of $2.7 billion was invested by VCs last year in medical devices and diagnostics, with $748 million of that total coming during the fourth quarter.
Philips announced that it will offer Indica Lab's Halo image analysis software platform with its Digital Pathology Solutions products to enable enhanced analysis of cancerous tissue samples. The upgraded product offering is for research use only, meaning it won't be used to make clinical decisions affecting individual patients.
A fresh wave of biopharma companies are partnering and investing in genome sequencing companies to integrate their data into the drug development process. The latest deal on this front pairs Roche with startup Human Longevity.
Improved access by researchers to corporate clinical trial data, much like open-source software, is expected to help facilitate a conversation between academia and the business world that could both facilitate translational research and help to validate corporate research. Yale University and Johnson & Johnson have announced the first such deal to enable external investigator access to medical device and diagnostics clinical data from J&J.