Recent med tech IPO success story Nevro has garnered an approvable letter from the FDA for its Senza spinal cord stimulation system to treat chronic pain, according to the company. Nevro said it needs to address manufacturing and product labeling issues in order to attain FDA approval.
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 past 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.
Investors open to the life sciences are looking more to med tech, particularly for IPOs where there have been a slew of recent diagnostic and device filings. There's a broad perception that the quality of biotech IPOs is becoming more uneven and that medical devices and diagnostics, which have had an almost nonexistent IPO market for years, could provide high-quality alternatives.
We pulled the data for the top medical device and diagnostic company performers, but we limited it to those with a valuation of more than $2 billion to assess those that are most relevant to major investors.
A titanic struggle is nearing its end. Rivals Boston Scientific and Johnson & Johnson are done presenting their arguments in a legal spat involving the disastrous 2005-2006 bidding war and purchase of cardiology player Guidant. The purchase threatens to become an even worse decision for acquirer Boston Scientific, which would owe $7.2 billion if J&J gets its way.
The suit centers on the role played by Abbott Labs,which allowed Boston Scientific to steal Guidant from Johnson & Johnson at the last second. By promising to buy some of Guidant's product lines from Boston Scientific upon the closure of the deal, Abbott freed Boston Scientific of antitrust concerns, enabling it to complete the $27 billion acquisition. J&J says Guidant violated its confidentiality agreement when the then-"hot" company allowed Abbott to inspect its business in order to make the side deal with Boston Scientific.
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Profit down 12% at Intuitive Surgical, but procedure volume up due to strength abroad and in general surgery
Procedures conducted using Intuitive Surgical's da Vinci robot rose 9% in 2014, on the back of strong growth in general surgery, CEO Gary Guthart said during the company's fourth quarter earnings call.
GE touted the strength of its healthcare business in the U.S., saying the country compensates for slowing growth in countries like Japan and Russia and is a headwind against unfavorable exchange rates abroad.
French in vitro diagnostics outfit bioMérieux and Astute Medical are teaming up to develop Astute's test for acute kidney injury, continuing the companies' recent diagnostics winning streak and helping them capitalize on a growing market.
The FDA has approved a second-generation Medtronic device to treat gastroparesis patients who are not able to control nausea and vomiting using drugs. The Enterra II System has been approved under a humanitarian device exemption, which is used by the agency to approve devices intended for a population of fewer than 4,000 people in the U.S.
In the latest act of the vaginal mesh litigation drama, plaintiffs' lawyers disputed J&J's claims that fishy phone calls recruiting women to file vaginal mesh-related suits are tainting the legal process and deserve further investigation.
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.
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Merck is financing a $1.85 million study being conducted at Texas Tech University to see if lower dosages of its lucrative but controversial cattle growth drug Zilmax could allow the company to reintroduce the product to U.S. and global markets and kick-start sales.
A survey of 2,000 pet owners conducted by Bayer HealthCare Animal Health and the Companion Animal Parasite Council has revealed that when veterinarians provide information to clients about parasites prevalent in their area, they can drive up clinic visits.