News

Study: BrainScope's investigational device shows promise in stroke diagnosis

A study of 183 patients the journal Academic Emergency Medicine found an investigational non-radiation emitting, handheld device developed by BrainScope to be a valuable adjunct to standard CT and MRI scans in the diagnosis of stroke.

Cerus uses momentum from recent FDA approvals to raise $70M

Cerus is up almost 40% in the last month on news of a couple of approvals for its Intercept Blood System to treat blood products. The small cap took advantage of that upswing to raise $70 million to help finance commercialization of the system.

Alere snags first FDA CLIA waiver for molecular influenza test

Alere won an FDA CLIA waiver for its molecular influenza test, giving the company a boost amid restructuring efforts and putting its diagnostic in the hands of more healthcare professionals as flu season reaches epidemic status.

FDA clears pivotal trial for permanent use of artificial heart

SynCardia Systems is aiming to have the first artificial heart approved by the FDA for permanent use. The agency has approved a pivotal trial design to test the startup's Total Artificial Heart as a heart replacement.

Shockwave's energy-delivering angioplasty balloon for PAD receives CE mark

On the heels of the FDA's approval of a second drug-coated balloon for peripheral artery disease, Fremont, CA's Shockwave Medical announced the receipt of a CE mark for its Lithoplasty balloon catheter which delivers lithotripsy, a pulsating form of mechanical energy, prior to performing angioplasty.

New technology can spot cavities early, but is that necessary?

The $14,000 Canary System is a new technology that can detect signs of tooth decay earlier than an X-ray can. It uses lasers to grade teeth on a 100-point scale and can enable earlier intervention. But insurance companies aren't reimbursing the Canary System, fearing overtreatment.

Medtronic and Covidien win shareholder approval for proposed $43B merger

Medtronic and Covidien are nearing the finish line of their pending $43 billion merger as Medtronic shareholders voted on Tuesday to approve the deal, following in the footsteps of a similar vote from Covidien shareholders. 

Day one agenda for congressional Republicans: Repeal of medical device tax

The Republicans are set to take over Congress on Jan. 7, and the Affordable Care Act will be in their crosshairs. While a repeal of the entire law will meet President Obama's veto pen, the elimination of the medical device tax is more feasible, and an appealing way for Republicans to gut the law.

Novel surgical adhesive gets approvable letter, FDA approval anticipated 'within a few weeks'

Cohera Medical has received an approvable letter for its PMA application for TissuGlu Surgical Adhesive. The company said it expects an FDA approval for the application "within a few weeks" in a statement. If so, TissuGlu would be the first internal surgical adhesive of its kind approved in the U.S., according to the company.

Qualcomm to connect medical devices to cloud for Walgreens, Novartis

Qualcomm announced medical device-related partnerships with Walgreens and Novartis at the Consumer Electronics Show in Las Vegas. Qualcomm's contribution to the partnerships will be the cloud-based data-sharing Life2Net platform, described as a nonexclusive, interoperable system for delivering healthcare.

Med tech exits pick up in 2014, momentum to continue into 2015

Venture-backed medical device and diagnostics companies are benefiting from a groundswell of investor interest in life sciences that has been spearheaded by great biotech returns for the last several years.

Health devices take the stage at Consumer Electronics Show

New health devices are front and center at this week's Consumer Electronics Show, reflecting the overwhelming, ongoing convergence of medical devices with information technology as well as their ever-growing consumerization.

Covidien (and Medtronic) have high hopes for the lung cancer treating superDimension

Covidien is working on a new version of its superDimension device that can eliminate the need for a bloody incision when performing a lung biopsy.

GlySens gets $12M Series C for implantable continuous glucose monitor

GlySens will use a $12 million Series C financing to conduct a clinical trial for a second iteration of its receiver and implantable sensor that enable continuous glucose monitoring for diabetic patients.

UPDATED: FDA approves Medtronic's drug-coated balloon, setting up clash with Bard in new U.S. market

The FDA gave PMA approval to Medtronic's IN.PACT Admiral drug-coated balloon for the treatment of peripheral artery disease in the upper leg, making it a competitor to C.R. Bard's recently approved Lutonix 035 balloon.

Med techs Avinger, HTG file for IPOs

Catheter-based peripheral artery disease treatment company Avinger filed with the SEC to raise up to $69 million, while molecular diagnostics player HTG Molecular Diagnostics filed to raise up to $60 million. In addition, orthopedic regenerative medicine player CollPlant is reportedly seeking a listing on a U.S. market; it is already listed publicly in Israel.

FDA deems Halyard's recalled KimVent endotracheal tubes potentially deadly

The FDA slapped Halyard Health's KimVent Microcuff endotracheal tubes with its most severe, Class I recall label, meaning "there is a reasonable probability that use of these products will cause serious adverse health consequences or death," according to the agency.

Aethlon Medical snags FDA approval for clinical trial of Ebola device

As med tech companies home in on innovative ways to quell the growing Ebola outbreak, Aethlon Medical snagged FDA approval for a clinical trial of its biofiltration device in patients with the virus.

Survey: Most U.S. consumers eager to use wearable devices to monitor their health

According to a recent survey, most U.S. consumers are eager to use wirelessly connected, wearable devices to monitor their health related to weight loss, yet slightly fewer than half who participated in the poll were concerned about their blood pressure.

Sen. Warren urges CMS to get on board, encourage UDI info in insurance claims forms

Rumored presidential candidate Sen. Elizabeth Warren (D-MA) wrote a letter to the administrator of the Centers for Medicare & Medicaid Services focused on an issue of great concern to the med tech employee constituency: Unique Device Identification. Co-authored with Sen. Charles Grassley (R-IA), the letter to Administrator Marilyn Tavenner urges CMS to side with various medical associations, think tanks and private insurance companies in support of including UDI information in insurance claims forms.