News

HeartWare issues recall again for implantable heart pumps due to risk of death

HeartWare has issued a voluntary recall of some of its Ventricular Assist System Controllers due to their higher susceptibility to electrostatic discharge than some newer, commercial controllers. An electrostatic discharge can cause a pump to stop, which could result in serious injury or death.

Medtronic works to boost neuromodulation with bladder control startup acquisition

Medtronic has just disclosed that it bought Advanced Uro-Solutions in December 2014 for an undisclosed amount. In August 2013, the FDA cleared the startup's neurostimulation device, the Nuro System, to treat overactive bladder and its associated symptoms of urinary urgency, urinary frequency and urge incontinence.

J&J readies to rid itself of Cordis--for as much as $2B to Cardinal Health

A deal that was rumored this summer now looks like it's ready to come to pass. Johnson & Johnson is ready to sell off its Cordis business to Cardinal Health for as much as $2 billion, according to report by Bloomberg. Cordis has elicited multiple offers from bidders, some of whom may still be in the running.

First adhesive varicose vein treatment wins FDA approval

With the FDA approval of Covidien's VenaSeal closure system, medical professionals can for the first time treat varicose veins in the legs by using an adhesive to cut off blood supply.

Advisory panel recommends FDA approval of VertiFlex's spinal implant

An orthopedic advisory panel voted to approve Vertiflex's PMA application to the FDA for its Superion Interspinous Spacer, a spinal implant designed to treat moderate lumbar stenosis and pain, numbness and/or leg cramps related to the condition.

GE explains the recall of its MRI systems to FierceMedicalDevices

GE told FierceMedicalDevices in an email that the recall was voluntarily initiated following a single safety incident in India, where some users had disabled the so-called magnetic rundown unit, because the company "wanted to ensure that the human error was not occurring at other sites globally."

Med tech makes the WSJ billion-dollar startup club: Theranos, Intarcia and Proteus

At least three med techs made this year's accounting by The Wall Street Journal estimating the most valuable private companies.

KKR-backed Panasonic Healthcare to buy Bayer diabetes device biz for as much as $2.3B

Bayer is slated to sell its diabetes devices business to Panasonic Healthcare, according to a report from Bloomberg. The move has been years in the making as Bayer works to sell off peripheral businesses to focus on its core profitable ones.

Medtronic prepares to head back to FDA with deep brain stimulation for epilepsy

Medtronic has published detailed results for the first time of a 5-year trial for deep brain stimulation therapy in treatment-resistant epilepsy. The device giant has said that it will make another run at an FDA approval for its DBS device in that indication.

23andMe nabs FDA marketing clearance for direct-to-consumer genetic carrier test

23andMe scored FDA clearance to market its direct-to-consumer genetic carrier test for Bloom syndrome, a crucial win for the company as it continues to make good with the agency and expand the reach for its genetic tests.

Integra LifeSciences lays off 49 in Massachusetts as part of facility consolidation drive

Surgical Instrument provider Integra LifeSciences laid off 49 employees in Massachusetts as part of a cost-saving initiative, MassDevice reports, citing a public notice filed under the federal Worker Adjustment and Retraining Notification Act.

New studies shed light on power morcellator devices in surgical procedures

Months after the FDA recommended against using laparoscopic power morcellator tools for the "majority" of women undergoing certain gynecological procedures, two new studies are adding to a growing body of literature scrutinizing the devices.

Medtronic, Bard secure supplemental Medicare reimbursement for their new drug-coated balloons

Medtronic and C.R. Bard announced that they have obtained supplemental Medicare reimbursement for peripheral artery disease outpatients who are treated using their recently approved drug-coated balloons.

Wearable insulin delivery device shown effective in trial for three-day use

Several companies are experimenting with long-term wearable insulin delivery systems that work via continuous subcutaneous infusion to help ease the administration of the medication, thereby making it easier for patients to remain compliant. One such system from startup CeQur recently reported data from a small pilot study.

FDA warns of device design amid UCLA superbug outbreak

Amid a drug-resistant "superbug" outbreak at the UCLA Health System in California, the FDA is warning doctors and hospitals that endoscope devices' complex design may hinder proper cleaning, contributing to the spread of deadly bacteria.

AliveCor's new heart monitoring app crashes, recalled by company

AliveCor has recalled the Alive ECG App 2.1.2 for its mobile phone-enabled AliveCor Heart Monitor electrocardiogram.

Bioartificial adrenal device readies to follow bioartificial pancreas into the clinic

Startup Beta-O2 Technologies already has a bioartificial pancreas in a tiny three-person clinical trial. Now, it has preclinical data for its next device that uses the same implantable bioreactor technology with a new cell type--the βAir Bio-artificial Adrenal system.

Biotronik completes Dreams bioresorbable stent trial enrollment after several delays

Biotronik announced that the second clinical trial of its Dreams drug-eluting bioresorbable stent met another milestone as it races to become the third player in the emerging space. The Biosolve-II trial has completed enrollment, the company said. Its primary outcome measure is late lumen loss at 6 months, according to ClinicalTrials.gov.

Rumor: China's Fosun to buy Israeli laser medical device maker Lumenis for almost $500M

Chinese conglomerate Fosun Pharma is reportedly in talks to acquire minimally invasive procedure player Lumenis for $480 million. As expectations of the deal leaked, Lumenis has gained about 14% to a market cap of around $410 million.

FDA panel to consider PMA application of spinal implant

The FDA's orthopedic advisory panel will investigate the agency's concerns about fractures to the back of the spine resulting from the investigational VertiFlex Superion Interspinous Spacer as it deliberates on Feb. 20 whether to recommend the device's PMA application for FDA approval.