News

Medtronic to pony up funds in $525M IRS tax settlement

Medtronic inherited Covidien's tax-friendly Irish domicile last year after the companies finalized their $50 billion merger. But the devicemaker also picked up a tax scuffle from Covidien's former parent company, and now, Medtronic is laying that battle to rest in the form of a $525 million settlement.

Novocure moves beyond brain cancer, touts pancreatic cancer data

Novocure announced that it will present data on Friday at a meeting of the American Society of Clinical Oncology showing that its Tumor Treating Fields therapy and first-line chemotherapy is tolerable and safe in advanced pancreatic cancer, as it seeks to earn FDA approval for the use of its noninvasive cancer-fighting device to treat other types of cancer besides glioblastoma.

Google's Verily, AHA, AstraZeneca team up for heart disease R&D with $75M

The American Heart Association, Verily (formerly Google Life Sciences) and AstraZeneca have chipped in a total of $75 million over 5 years to support "one brave idea from a visionary leader" to cure coronary heart disease.

Singaporean company barred from selling devices in U.S. after turning down FDA inspection

A subsidiary of Singapore's Biosensors International can no longer sell devices in the U.S. because it failed to respond to a request for FDA inspection.

FDA releases guidance on post-market steps for improving medical device cybersecurity

From "poor cybersecurity hygiene" to "I need FDA permission to update this cybersecurity software," the number of trite excuses explaining why medical devices have been left unprotected from cyber-attacks keeps on growing.

NIH, DARPA-backed researchers develop wireless, dissolvable brain sensors

Scientists have developed brain implants to monitor pressure and temperature after traumatic brain injury that dissolve over a few days. The idea is that these could be implanted during surgery on TBI patients in order to conduct subsequent monitoring, but then they would not require removal.

Imaging informatics upstart gets FDA nod for oncology screening software

HealthMyne has secured 510(k) clearance for its analytics software package that's designed to offer radiologists information in oncology imaging studies. The software from the Madison, WI-based company is designed to work as part of an Epic electronic health record and to offer tracking of specific nodules or tumors over time. The software is used to analyze its relative size and location.

Startup raises $19M to market suture-replacing, Zip skin closure products

ZipLine Medical has won $19 million to back its marketing of its Zip Surgical Skin Closure products--which are intended to be as speedy as staples but with an outcome that's comparable to sutures, thereby saving time and money in the operating room. The Campbell, CA-based startup was founded in 2009 and had raised only about $6 million in two previous financings.

J&J axes 3,000 jobs in bid to save $1B and revive lagging medical devices business

Johnson & Johnson's medical device segment has become something of a red-headed stepchild for the company, with sales for the unit lagging behind its fast-growing pharma business. But the company is rolling out a game plan to get things back on track, with job cuts featuring at the top of its to-do list.

Second activist investor buys 5% stake in HeartWare, putting Valtech deal in doubt

HeartWare's acquisition of Israeli cardiac implant maker Valtech Cardio is now in even greater jeopardy. Reuters reports that a second group of activist investors, led by former J.P. Morgan CFO Doug Braunstein, purchased a 5% stake in the struggling company in hopes of blocking the transaction.

MLK holiday note

Editor's Note: We will not be publishing our daily FierceBiotech, FiercePharma or FierceMedicalDevices this coming Monday, January 18, in recognition of Martin Luther King, Jr., Day. Our normal...

FDA signs off on new version of Olympus' duodenoscope amid mounting scrutiny

The FDA has signed off on a new version of Olympus' controversial duodenoscope device, days after a cadre of lawmakers came down on the agency and the company for playing down early problems with the products that were linked to superbug outbreaks in the U.S.

Robotic surgery company Hansen Medical puts itself up for sale

Intravascular robotics company Hansen Medical of Mountain View, CA, is exploring strategic alternatives, including but not limited to "a licensing transaction, a refinancing transaction, a strategic business combination, partnership, a possible sale or disposition of one or more corporate assets or the company itself."

JPM: Don't expect any splashy device acquisitions from J&J

Johnson & Johnson ($JNJ) CEO Alex Gorsky struck a skeptical tone when it comes to large M&A deals at the J.P. Morgan Healthcare Conference in San Francisco, stressing the company's desire to return money to shareholders, including about 50% in the form of dividends.

Edwards works to expand TAVR into intermediate risk, elderly patients to hit $5B market

Edwards Lifesciences estimated the transcatheter aortic valve replacement (TAVR) market as worth more than $5 billion by 2021. That's based on its expectation of an expansion into elderly and intermediate-risk populations. Last year, its Sapien 3 valve was approved by the FDA specifically for the treatment of high-risk patients suffering from severe, symptomatic aortic stenosis.

Boston Scientific targeted for 'international conspiracy' in latest vaginal mesh suit

Boston Scientific is facing more legal pushback over defective vaginal mesh devices, but this time, it's not from women who claim injuries or serious side effects from the products. A Houston-based law firm is cracking down on the company for allegedly smuggling mesh materials out of China and putting women at risk for serious side effects.

JPM: St. Jude plagued by gap in its portfolio of pacemakers and implantable defibrillators

St. Jude Medical needs to get its cardiac rhythm management unit back on track by filling gaps in the portfolio, CEO Michael Rousseau said at the J.P. Morgan Healthcare Conference in San Francisco.

Devices grab $2.7B in VC again, but that may weaken in 2016

Medical devices got a taste of an IPO market last year that's long been wide open for biotech. That came at the same time that the acquisition appetite for venture-backed device companies held strong. But there's a backlog of device portfolio companies that VCs need to get off their books before they can have any greater appetite for the device category.

NIH commits $313M over four years to sequencing genomics of human disease

The National Institutes of Health has launched a program to explore the role of genomics in common diseases such as heart disease, diabetes, stroke and autism. This program has gained a commitment for $313 million in NIH funding from various agencies over the next four years.

GE on the move: HQ moving to Boston, Healthcare to Chicago

General Electric is moving its corporate headquarters from Fairfield, CT, to Boston. The move was likely inspired by the growing desire of workers to live in urban areas. Regardless, Boston's booming med tech (and biopharma) scene will be a boon for the company's device unit. In fact the company said it will move 600 digital industry product managers to the new HQ, including some in charge of life science-related technology.