News

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.

Surgeons tout benefits of Google Glass in operating room

As wearable devices pick up speed as viable surgical tools, physicians are touting the benefits of Google Glass technology for use in operating room procedures.

FDA lowers regulatory bar for neurostimulators to treat headache

Soon, transcutaneous electrical nerve stimulation to treat headache will only require a 510(k), the FDA said in a July 3 final order published in the Federal Register.

Boston Scientific backs Israeli cardio device startup Mvalve with $15M

Israeli cardiovascular device startup Mvalve Technologies has received a $15 million convertible loan from BSC International Holdings, a subsidiary of Boston Scientific. In addition, BSC received an option to acquire Mvalve for $200 million, according to the Israeli business publication Globes.

Covidien picks integration chief for Medtronic merger

As Covidien strides into a merger with Medtronic, the company last week announced the appointment of Bill Burke as CFO for Covidien Europe.

FDA unveils HeartWare warning letter for company's ventricular assist device

The FDA slapped HeartWare International with a formal warning letter one month after citing the company for safety issues related to its HeartWare Ventricular Assist Device system.

Senators call on White House to release FDA guidance on lab-developed tests

Five senate Democrats called for the White House Office of Management and Budget to release a long-sequestered FDA draft guidance on laboratory developed tests for public comment. In a letter to OMB acting director Brian Deese, they urged him to release the proposed regulation "to ensure appropriate and efficient oversight of diagnostic tools can move forward in an open and transparent manner."

Study: Insulin pumps control glucose better than daily shots for Type 2 diabetics

Insulin pumps do a better job of helping control glucose levels in people with Type 2 diabetes than multiple daily injections, according to results from a new study funded by medical device maker Medtronic.

FDA clears first vital sign sensor for chairs

An early step for any hospital patient on the mend is often walking from bed to chair. Physicians have long recognized that walking and sitting upright aids in the healing process but this can be complicated given the various leads and attachments necessary for patient monitoring. Now the FDA has cleared the first sensor to monitor heart rate, respiratory and movement monitors in a chair.