News

Thermo Fisher beefs up its animal health Dx offerings with a Swiss acquisition

A little over a month after Thermo Fisher closed its gigantic $13.6 billion buyout of Life Technologies, it has completed the acquisition of Prionics AG, a privately held Swiss animal health diagnostics company.

China cracks down on bogus med tech websites

Despite China's massive investment into modernizing its healthcare infrastructure and services, the market still has a bit of a wild-west feel that can jeopardize the reputation of med tech companies and place patient safety at risk. Xinhuanet (part of the Xinhua News Agency) reported that the country's main regulatory agency determined that 10 websites published fraudulent medical device information, including fake devices for sale.

K2M makes it official: The spinal surgery outfit is exploring a $100M IPO

K2M hinted in January that it would explore an IPO, and now the details are out. The Virginia-based spinal surgery company filed formal plans to jump into the public markets, and it will seek as much as $100 million.

French surgeons perform closed-heart surgery using a nitinol stent

Without opening the chest, surgeons have for the first time conducted an endoscopic aortic valve replacement with a small incision in the patient's sternum and the placement of a compressible, self-expanding nitinol stent, the team published in the Journal of Thoracic and Cardiovascular Surgery.

Sorin snatches up a Florida manufacturer's cardiac-lead business for $20M

Sorin Group is paying $20 million for a Florida manufacturer's cardiac-lead business, as well as its plans for new MRI-compatible cardiac leads.

Hologic adds a COO, loses a CFO in a C-level shakeup

In another round of corporate musical chairs, diagnostics giant Hologic implemented a series of leadership changes designed to give it a much-needed boost.

Stentys touts a revenue bump and cash to burn for its U.S. push

Stentys burned more cash in 2013 as it launched a U.S. clinical trial for its cardiac stent. The French devicemaker reported revenues up 34% over the previous year.

Boston Scientific bets on a big future for bare metal stents

Boston Scientific gained a CE mark for a new platinum bare metal stent to treat coronary artery disease.

Quest Diagnostics is proposing a $600M debt refinancing

Add a major debt-refinancing move to Quest Diagnostics' ongoing effort to revamp itself. The New Jersey diagnostics giant said it will offer $600 million in two series of senior notes under a shelf registration statement previously filed with the SEC.

Vaginal mesh lawsuits are escalating in Scotland

Hundreds of women in Scotland are prepping lawsuits alleging that their vaginal mesh implants caused them harm, underscoring the global nature of the brewing legal mess behind the controversial medical devices.

Roche gets glowing reviews from FDA panel for frontline HPV test

In another win for Roche, a panel of experts unanimously recommended that the company's HPV test could be used for primary screening of cervical cancer.

FDA hits Philips Respironics with a Class I recall over ventilator power glitch

The FDA cited Philips Healthcare subsidiary Philips Respironics with a Class I recall--the agency's most serious designation--for 600 of the company's Trilogy ventilators due to an electrical defect that could result in catastrophic failure of the device.

GE Healthcare gauges impact of Madison, WI, plant with new study

The Wisconsin State Journal reported that the 630-employee medical device manufacturing plant in Madison, Wisconsin, run by GE Healthcare channels close to $342 million into the state's economy.

The FDA smacks Hospira again over NC manufacturing problems

The FDA is slamming Hospira again over more problems at its Rocky Mount, NC, manufacturing facility. The maker of infusion pumps, injectors and other related medical devices disclosed it faces yet another warning letter from regulators based on more quality system violations.

J&J's $2.5B-plus metal hip settlement offer approaches April 1 deadline

Patients have until April 1 to decide whether to sign on to the $2.5 billion-plus agreement Johnson & Johnson proposed last November to resolve 8,000 patient lawsuits involving defective all-metal hip implants. It's not clear yet whether the conglomerate will draw in enough people so the settlement can move forward.

First-of-its-kind migraine prevention device wins FDA approval

In a first, the FDA has approved a medical device designed to prevent migraine headaches. Designed by Cephaly Technology in Belgium, the product, dubbed Cephaly, is a small, portable, battery-powered plastic headband worn across the forehead and just above the ears.

Myriad can't stop Ambry Genetics from selling its breast cancer test--for now

In a courtroom development that does not bode well for Myriad Genetics' efforts to protect the BRCA breast cancer diagnostic technology it pioneered, a U.S. District judge in Utah dismissed the company's motion for a preliminary injunction to stop Ambry Genetics from selling its own version of the BRCA test.

Fresenius Medical Care to pour $140M into Tennessee manufacturing expansion

Germany's Fresenius Medical Care is pursuing a major expansion in Tennessee. The company's North American division plans to invest $140 million into building a new manufacturing facility in the Knox County/Innovation Valley region and create 665 jobs over time.

PowerVision implants fluid intraocular lenses into 10 patients

It's a crowded market for ophthalmological devices, and PowerVision wants to keep a leg up on the competition: As part of a new multicenter clinical study, the company implanted its innovative fluid-based intraocular lens into 10 patients.

AngioDynamics gains expanded FDA clearance for its bypass device at a crucial time

AngioDynamics said it won expanded FDA clearance for one of its key vascular access devices, a development that could help it boost the market reach for a product it bills as a healthcare cost-cutter.