The FDA has applied its most serious label to Atossa Genetics' recall of a breast cancer diagnostic, warning that using the unapproved devices could lead women to forego treatment and increase their risk of serious injury and death.
Executives at Israel's Syneron Medical said the company's 2013 third quarter reflects significant progress in expanding the North American market for its cosmetic lasers and other related aesthetic medical devices, plus steady growth in overall revenue aided in part by job cuts and other cost-cutting measures.
Myriad Genetics is debuting a new melanoma skin biopsy test in the U.S., and will begin a similar effort in "key European markets" starting in early 2014.
Johnson & Johnson reportedly negotiated a deal that will, at long last, resolve more than 7,500 lawsuits from patients who had faulty all-metal hips made by the company surgically removed. Bloomberg broke the news, citing three anonymous sources. If true, the settlement is astoundingly high, worth more than $4 billion.
Singapore's Biosensors International can thank an acquisition and growing sales of stents and other cardiac devices for generating good gains in 2014 second quarter revenue. But the restructuring led to a dent in profits, and the company lowered its full-year guidance based on overall weak market conditions.
Over the summer, California's Scanadu made headlines around the world with Scout, its handheld diagnostic tool that raked in $1.6 million through crowdfunding platform Indiegogo. Now the company is ready to take its novel device to the clinic, securing a $10.5 million Series A and plotting its first trials.
Solta Medical, a maker of medical devices focused on liposuction, skin resurfacing and other aesthetic areas, will reorganize, slash jobs and may even sell itself in a bid to reverse slumping sales.
Med tech giant Hologic posted another strong quarter of revenue growth, but a colossal $1.1 billion goodwill impairment charge washed away net income, startled investors and sent the company's shares down about 13% overnight.
Hospitals may be forced to boost training for surgical robots made by Intuitive Surgical in response to reports that adverse events linked to their use are on the rise.
Israel's Sensible Medical has picked up a reported $20 million to fund development of its noninvasive lung fluid monitor, closing a round led by global device giant Boston Scientific.
The U.S. coronary stent market is already crowded and competitive, but Israel's ITGI Medical sees room for at least one more player. It recently inked a deal with Vascular Solutions that helps propel the regulatory process and then marketing for its pericardium-covered stent after getting it approved for use.
Cleveland's CardioInsight has picked up $15 million in financing to support its non-invasive tool for mapping the heart and diagnosing electrical disorders, giving it fresh cash to get the device cleared in the U.S.
The FDA's probe into the safety and effectiveness of Intuitive Surgical's robotic da Vinci system points to a muddled conclusion: Surgeons said the devices have a strong benefit but point out that inconsistent training can put patients at risk.
Novartis said it will sell off its blood transfusion diagnostics arm to Spain's Grifols for $1.7 billion in a bid to narrow its focus.
The Massachusetts Attorney General's Office took Pfizer ($PFE) and Mylan Specialty to task for an ad that they said went too far in promoting how effective the EpiPen is in treating major allergic reactions. The Boston Business Journal reported that Pfizer, which makes the product, and Mylan Specialty, which markets it under license, must pay a $625,000 fine to settle charges in the case.
Oxford Immunotec Global is keeping the IPO boomlet running strong; the U.K./U.S. developer of tuberculosis blood tests has announced its terms in a new regulatory filing. Plans call for offering nearly 5.4 million shares at between $13 and $15 per share.
Topera, developer of a 3-D device and mapping tool designed to detect cardiac rhythm problems, is ramping up commercial sales of its debut technology in the U.S. and Europe now that crucial regulatory sign-offs are in place.
The automatic budget cuts known as the federal sequester have taken away approximately $85 million in medical device and pharmaceutical FDA user fees away from the agency, the White House's Office of Management & Budget has confirmed.
Prominent Chinese investors have set their sights on Canada's Medical Devices Innovation Institute (MDI) for 7 new devices that could have over $1 billion each in sales potential, according to the institute's estimates.
Covidien grew medical device sales slightly at the end of its 2013 fiscal year. But overall net income dropped as the company continued to adjust to a future without pharmaceuticals and dove into a massive restructuring plan.