News

FDA panel recommends stronger labeling, limiting use of power morcellation--agency may go further

The FDA panel convened to discuss the risk of upstaging uterine sarcoma cancer via minimally invasive laparoscopic power morcellation during uterine surgery for fibroids recommended upgrading the labeling of power morcellators and ensuring that patients are made aware of the risk prior to surgery, among other measures.

Patent 'troll' legislation passes U.S. House subcommittee with some industry support

The U.S. House of Representatives Subcommittee on Commerce, Manufacturing, and Trade voted on Thursday to approve legislation intended to curb the practice of companies asserting patent rights solely to collect licensing fees, rather than offering products or services based on those patents.

Kennedy nonprofit One Mind backs neurological trials using Moberg brain monitors

Former U.S. congressman Patrick Kennedy visited the Moberg Research facility in Ambler, PA, on Wednesday to discuss the use of Moberg's technology for neurological research.

ReWalk Robotics marches to market with $58M IPO

Two weeks after scoring an FDA nod for its innovative robotic exoskeleton, ReWalk Robotics is marching to market with a $58 million initial public offering.

Philips Healthcare chief DiSanzo out in management shakeup

The chief of Philips Healthcare, Deborah DiSanzo, has left the company ahead of what is expected to be disappointing Q2 earnings. The unit will now report directly to CEO Frans van Houten, The Wall Street Journal reported.

Day One: Inside the FDA power morcellator panel

Panelists were concerned about the lack of data on the prevalence of uterine sarcoma among women undergoing hysterectomy or myomectomy surgeries during the first day of the FDA panel on the risks of upstaging uterine cancer via minimally invasive laparoscopic power morcellation during uterine surgery for fibroids.

Smith & Nephew partners with startup for knee surgical system

Orthopedic specialist Smith & Nephew will market Blue Belt's surgical knee system in a worldwide agreement that could help breathe fresh life into Smith & Nephew's flagging knee implant revenue growth. The partnership with Smith & Nephew is the startup's first major distribution deal.

Boston Scientific's Guidant faces more legal pushback in J&J lawsuit

Boston Scientific's Guidant subsidiary faces more legal pushback in its ongoing breach-of-contract lawsuit against Johnson & Johnson, as a federal judge denied the company's request to toss out the case.

DOD awards $40M for wireless implant for memory loss due to brain injury

Soon, there will be a device to cure some forgetfulness if the Department of Defense's four-year grant of up to $40 million succeeds in fostering implants and electronic interfaces that diagnose and treat memory loss due to traumatic brain injury.

SCOTUS decision may make it easier to invalidate device patents

In a unanimous Supreme Court decision early last month, a ruling on Biosig Instruments' heart-rate monitor patent was deemed invalid.

USGI Medical prepares U.S. pivotal data for obesity device

USGI Medical, a California-based devicemaker focused on incisionless, endoscopic procedures for weight loss, reflux and advanced therapeutic endoscopy, said enrollment has been completed for a pivotal study to evaluate the company's POSE (Primary Obesity Surgery, Endolumenal) procedure.

FDA clears oral sleep apnea device, as search for CPAP alternatives continues

Australia's SomnoMed Limited hopes that its just now 510(k)-cleared devices for obstructive sleep apnea give it an advantage over the predominant therapy due to the products' ease of use. Unlike continuous positive airway pressure (CPAP) devices that require a facemask, SomnoMed's oral SomnoDent Fusion Classic and SomnoDent Fusion Flex are worn like a mouth guard.

Gynesonics aims for $35M for minimally invasive uterine fibroid device

Gynesonics has raised an additional $6 million in its march toward raising a total round of $35.5 million in equity and debt, according to an SEC filing. The additional cash is timely, coming on the heels of its receipt of a European CE mark for and treatment of the first patient with its next-generation VizAblate System in June.

BioVentrix crowd-funds $12.4M for heart failure treatment

Private heart failure treatment company BioVentrix has closed a $12.4 million equity financing. The deal was managed by microcap specialist brokerage Taglich Brothers and involved 195 undisclosed, accredited investors, according to an SEC filing.

JAMA study adds to robotic surgery safety concerns

A recent study found that the adoption of the da Vinci Surgical System in 2005 resulted in increased complications in minimally invasive prostatectomies because surgeons were learning on the job--to the detriment of patients.

India may alter medical device taxation that favors imports

India's medical device manufacturers hope the government's annual budget will address taxation that skews in favor of imported devices.

Zimmer, Biomet hit regulatory speedbump in pending merger

Zimmer's planned acquisition of Biomet may have hit a speedbump, as the U.S. Federal Trade Commission requested additional information regarding the companies' pending deal.

NeuroMetrix gains on FDA clearance of over-the-counter wearable chronic pain device

NeuroMetrix CEO Dr. Shai Gozani told FierceMedicalDevices that the now-FDA-cleared, over-the-counter version of its wearable therapeutic, the Sensus Pain Management System, will enable the company to pursue further innovations to the device that are not possible in the prescription market.

The Fiercest 15 in med tech: send us your best bets

Last year's Fierce 15 med tech winners include an implant maker for sinusitus that recently filed for an $80 million IPO, a fierce competitor to device giants Medtronic and Edwards Lifesciences in the emerging market for minimally invasive heart valves and a market leader in developing nerve-stimulating implant for rheumatoid arthritis and Crohn's disease. What will 2014 bring? That depends on you.

Valeritas raising $45M to market disposable insulin pump

Cash-hungry disposable insulin device maker Valeritas is raising $45 million in venture capital, according to an SEC filing. That could push the total amount the company's raised to more than $305 million since it was founded in 2006.