News

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.

FDA prepares to weigh risks of uterine fibroid removal tool

After months of warnings and a debate over the safety of laparoscopic power morcellators, the FDA begins its formal decisionmaking process July 10, when the Obstetrics and Gynecology Devices Advisory Committee convenes for two days in what will be one of the agency's most prominent meetings of the year.

Stomach-draining obesity device headed for FDA submission in 2015

A device to treat obesity, although it may be a bit difficult to stomach, is headed for an FDA submission in June 2015. Aspire Bariatrics has completed enrollment of a pivotal trial for its AspireAssist Aspiration Therapy and plans to submit a PMA then.

How it works: Anti-venom devices may neutralize mosquito bites

Mosquito-bite induced scratch attacks might be a thing of the past, if you're willing to heat your bites with electric shocks, a process rumored to soothe the itch.

Researchers develop real-time, 'nanojuice'-enabled imaging method for gut

Conventional imaging methods don't work so well in the gut, the site of irritable bowel syndrome, celiac disease and Crohn's disease among others. Researchers at the University of Buffalo say they have solved the problem, albeit in animal studies.

Ulthera device clears FDA for décolleté on heels of Merz acquisition plans

Merz already committed to buying Ulthera for up to $600 million in cash and milestones. Now it will get another FDA-cleared indication as part of the bargain. The company's system has cleared the FDA to improve the lines and wrinkles of the décolleté.