News

C.R. Bard battling bid from plaintiffs to consolidate pelvic mesh suits

C.R. Bard is resisting a bid from plaintiffs to consolidate 185 suits related to pelvic mesh products, adding fuel to the fire in its ongoing vaginal mesh litigation.

Startup gains FDA clearance for breast surgery guidance system

Cianna Medical has received clearance from the FDA for its SAVI Scout surgical guidance system. This is Cianna's second marketed product in addition to its SAVI breast brachytherapy applicator.

Up almost one-third in 2014, Cantel falls on Q1 earnings miss

Cantel Medical is up about 30% this year on investor enthusiasm for its sales growth in endoscopy, as well as a brisk acquisition strategy. But its shares were down about 1% in early trading on Dec. 10 after the company reported first quarter earnings that missed expectations a bit.

GI Dynamics restructures, considers strategic options after EU shipment halt

Micro-cap obesity device company GI Dynamics is restructuring by cutting 10% of its workforce, including its CFO, as well as reviewing its strategic options. The Australian company expects to communicate its next move "over the next several months," GI Dynamics' president and CEO, Michael Dale, said in a statement.

VertiFlex faces regulatory setback for spinal implant as FDA delays panel meeting

VertiFlex is facing a regulatory setback for its spine implant, as the FDA postponed a meeting slated to review the company's application for premarket approval of the device.

Texas Instruments launches chip for use in medical devices, wearables

Texas Instruments launched its first flexible, high-frequency sensor transponder.

Healthcare industry groups seek compatibility standards for medical devices

With the explosion of new technologies in medical devices, particularly personal wearable products that connect to smartphones through apps, healthcare industry groups have begun searching for ways to make sure data can be shared easily from platform to platform.

Welch Allyn buys up at-home patient monitoring tech from HealthInterlink

Established medical diagnostic device company Welch Allyn has bought up all the assets of telehealth startup HealthInterlink in its first foray into remote patient vital sign monitoring. Welch Allyn sees this as an early step in investing in post-acute care monitoring outside of a hospital setting.

BoneSupport, Orthocell partner to develop a novel bone repair product

Australian regenerative medicine company Orthocell and Scandinavian med tech BoneSupport will work together to combine their existing products into a new bone repair product. The pair hopes to further tap into the global bone graft and substitutes market, which the companies said was $2.1 billion last year and is expected to be $2.7 billion by 2020.

Edwards looks to TAVR to convince Wall Street it can go higher after doubling in 2014

Edwards Lifesciences wasn't quite sure what kind of sales to expect from its transcatheter aortic valve replacement (TAVR) technologies in 2014. It initially modeled a TAVR sales growth rate of 0% to 14% for the year, but ended up with a whopping 25% instead. That pushed its total sales growth rate to more than 10%, Edwards chairman and CEO Michael Mussallem told his audience at an investor meeting on Dec. 8.

WSJ examines disclosure of ties between FDA and medical device companies

Many FDA advisory committee members have financial links to devicemakers that they do not publicly disclose, which critics say rips into public trust of the agency.

Eurofins Scientific snaps up Boston Heart Diagnostics for $140M

Luxembourg-based Eurofins Scientific agreed to buy Boston Heart Diagnostics, an advanced diagnostics provider, for $140 million, the company said.

Stryker's OtisMed to pay more than $80M to settle DOJ case over knee replacement surgical devices

Since acquiring OtisMed in 2009, Stryker has been facing allegations from the U.S. Department of Justice (DOJ) that the company and its former chief executive officer illegally distributed knee replacement surgical devices after the FDA refused to approve the product. Now, Stryker and OtisMed have agreed to pay more than $80 million to resolve the DOJ case, laying criminal and civil complaints to rest.

Brain sensors go wireless in Brown University study

Scientists have developed a high-data-rate, low-power wireless brain sensor and published testing data on it in the latest issue of the journal Neuron. The researchers expect that these sensors could lead to new and unique patient data collection since subjects needn't remain tethered by cables.

Edwards gains option to acquire startup CardioKinetix in $50M financing

Edwards Lifesciences led a $50 million financing for catheter-based heart failure treatment startup CardioKinetix. The cash is expected to enable the completion of an ongoing U.S. pivotal trial for the company's Parachute Ventricular Partitioning Device with a PMA submission to the FDA to follow, as well as to finance international marketing efforts.

J&J gains FDA clearance for rare pediatric spinal device

The FDA has cleared the VEPTR and VEPTR II Vertical Expandable Prosthetic Titanium Rib Devices to treat children with thoracic insufficiency syndrome, a rare congenital condition that results in severe deformities of the chest, spine or ribs that impair breathing and lung growth.

Physicians weigh in on ventricular assist devices for treating heart failure

As the med tech industry casts its eye toward next-generation devices for severe cardiac conditions, physicians are weighing in on the products' efficacy in treating patients with heart failure.

National Cancer Institute backs startup's hazardous drug containment device

Corvida Medical is starting a research study for its technology to safely handle hazardous drugs. It's in the process of recruiting additional cancer centers to join the multicenter study designed to evaluate improvements to its first medical device, a closed system transfer device called the Halo.

BlackBerry, NantHealth to launch HIPAA secure smartphone genome browser

BlackBerry, maker of the Passport smartphone, and health analytics company NantHealth said they will launch a clinical genome browser early next year that will be HIPAA-compliant.

Tecomet acquires Symmetry OEM biz, becomes Symmetry Surgical

Symmetry Medical's OEM Solutions business was acquired by Tecomet.