News

Texas judge tosses out 76 suits in J&J's ongoing vaginal mesh litigation

Johnson & Johnson's Ethicon unit scored a victory in its ongoing vaginal mesh litigation as a federal judge in Texas tossed out 76 liability lawsuits related to the company's pelvic mesh devices.

FDA to more than double staff in China as visa issues appear resolved

The FDA is extending its tentacles deeper into China, which exported medical devices worth $3.5 billion to the U.S. in 2012, according to the U.S. Department of Commerce.

Brain tumor treatment device gets early trial halt for efficacy as a combo with chemo

The only FDA-approved, wearable cancer treatment device may expand its reach. A Phase III trial of Optune (NovoTTF-100A System) from Novocure was halted early due to statistically significant efficacy for the device in combination with chemotherapy to treat newly diagnosed glioblastoma patients.

Positive Phase II data for NeuroSigma comes after IPO postponement

NeuroSigma released top-line data for its noninvasive neuromodulation device to treat major depressive disorder. Next, the company plans a large, multicenter, double-blind clinical trial in this indication and may use that data to seek FDA approval.

Google's head of life sciences touts its upcoming wearable, nanoparticle-enabled diagnostic

The head of Google's life sciences team drummed up already-high interest in the company's developmental stage wearable diagnostic. The device will use magnets to "call" diagnostic nanoparticles so small that millions fit within a grain of sand, said life science team leader and Google X lab member Andrew Conrad at the WSJD Live conference

Medtronic partners with DaVita, rolls out CRT meta-analysis data

Dialysis provider DaVita HealthCare Partners has partnered with Medtronic for a pilot program to study cardiac arrhythmias in end-stage renal disease patients receiving dialysis. It will use the tiny implantable cardiac monitor, Linq, which Medtronic launched early this year.

LifeBond raising $25M to support development of surgical sealant technology

As the med tech industry zeroes in on next-generation surgical sealants, Israeli startup LifeBond is raising $25 million to support development of its bio-surgical glue for postoperative tissue repair.

 

New York Times: Hold off on knee replacement until it's necessary

New studies indicate that too many people may be deciding, prematurely, to go under the knife and have knee replacement surgery when they would be better off postponing the procedure until later in life, and opting for alternatives like exercise and weight loss in the near term.

UPDATED: FDA panel recommends approval of Alcon intraocular lens

FDA's Ophthalmic Devices Advisory Committee panel overwhelming recommended PMA approval of Alcon's ReSTOR Multifocal Toric Intraocular Lens for patients undergoing cataract eye surgery who are astigmatic and suffer from presbyopia.

Data registries: An extremely powerful tool, at least in theory

Data-gathering tools face a number of challenges including the integration of UDIs, differing device systems and components, and obtaining sufficient follow-up information, and capturing differences in provider experiences and training that could skew the outcomes data.

Swiss researchers create implant enabling mind-controlled protein release

Simply wishing away pain is not as far-fetched as you probably think, research from Swiss scientists shows. Using electroencephalography they were able to harness thought-specific brain waves to convert genes into proteins, or what's known as gene expression.

UPDATED: Trade agreement with China paves the way for reduction in medical device tariffs

President Obama's trip to China was a productive one. Not to be overshadowed by the countries' new climate change accord is an agreement to expand the World Trade Organization's tariff-cutting Information Technology Agreement, to include a host of new products, including medical devices.

Monteris nabs $30M to grow its less invasive neurosurgery tech

Canada's Monteris Medical announced a $30 million equity financing for its NeuroBlate robotic neurosurgical system to ablate, or destroy using heat, brain lesions like primary and metastatic tumors. 

Boston Scientific ordered to fork over $27.6M in vaginal mesh suit

Boston Scientific faced a stinging setback in its ongoing vaginal mesh litigation as a federal court jury ordered the company to pay $26.7 million to four women who claimed the devices caused them undue pain and suffering.

St. Jude 'looking' to expand production and services operations in Malaysia

Minnesota-based device giant St. Jude Medical is beating the bushes in Malaysia, possibly looking to expand its production and services operations there, Malaysia's New Straits Times reported.

Philips, Duke to collaborate on infant temperature monitoring using InnerSense probe

A lack of age-appropriate devices has led to complications in the infant temperature monitoring space. So, the news that Philips will use its InnerSense Esophageal Temperature Probe to monitor the core temperature of underweight infants in collaboration with the Duke University School of Nursing is welcome.

Congressional Republicans move full speed ahead to nix medical device tax

With positive midterm election results in tow, Republicans in the U.S. Congress are moving forward with plans to nix the medical device tax put in place two years ago under President Obama's healthcare law.

Smart earrings debut on Kickstarter

Canadian startup BioSensive Technologies is running a Kickstarter campaign to raise money to further develop its smart earrings, Ear-o-Smart.

Glooko merges tech data to avoid activity-triggered hypoglycemic events

Glooko, a startup focused on diabetes, has developed a tool that allows diabetics and their doctors to see what impact physical activity has on their conditions. It merges information from fitness wearables and biometric devices to help avoid hypoglycemic events.

Consultant says Sunshine Act leads to implicit coordination of payments to docs

Under the Sunshine Act, the new Open Payments database of payments made to physicians is leading life science companies to "implicitly" coordinate their payments in order to avoid being seen as the big payer to a particular doctor.