Medical Device Industry News

FDA panel votes against EDAP's ultrasound prostate cancer ablation

July 30, 2014 by Ingrid Mezo

The FDA's expert advisory panel votes that French device maker EDAP failed to demonstrate that it's novel Ablatherm prostate cancer treatment is safe and effective.

FDA panel rejects EDAP's ultrasound prostate cancer ablation

The FDA's Gastroenterology & Urology Devices panel today voted against recommending approval of EDAP's (NSDQ:EDAP) Ablatherm system for thermal ablation of the prostate gland to treat low-risk, localized prostate cancer.

MassDevice.com +3 | The top 3 medtech stories for July 30, 2014

July 30, 2014 by MassDevice

Plus 3

Say hello to MassDevice +3, a bite-sized view of the top three medtech stories of the day. This feature of MassDevice.com's coverage highlights our 3 biggest and most influential stories from the day's news to make sure you're up to date on the headlines that continue to shape the medical device industry.

 

T2 Biosystems boosts IPO cap to $78.2M

July 30, 2014 by Arezu Sarvestani

MRI diagnostics maker T2 Biosystems releases details on its initial public offering, hoping to raise as much as $78.2 million at $17 per share.

T2 Biosystems boosts IPO to $72.8M

Massachusetts-based  raised its hopes for its upcoming initial public offering, raising its maximum aggregate take to $78.2 million if shares sell at $17 apiece.

Massachusetts mulls tax credit to offset medical device tax

July 30, 2014 by Brad Perriello

Massachusetts Gov. Deval Patrick establishes a commission to study a possible tax credit to offset the 2.3% excise tax on U.S. medical device sales for the Bay State's medtech cluster.

Massachusetts mulls tax credit to offset medical device tax

Updated July 30, 2014 with comment from MassMEDIC

Massachusetts Gov. Deval Patrick is establishing a special commission to study granting a tax credit to the Bay State's medical device companies to offset the medical device tax.

Medical device makers face new obstacles to European approval

July 30, 2014 by Arezu Sarvestani

New materials regulations in the European Union mean medical devices have one more layer of red tape to cut through before they can reach the market.

Medical device makers face new obstacles to CE Mark

Medical device makers looking to bring new products to the European market will find a new layer of regulation before they can attain CE Mark approval.

The European Commission's new hazardous substances restrictions now apply to medical devices for the 1st time, requiring that all products coming to the E.U. market after July 22, 2014, meet materials standards before they get market approval.

Haemonetics ticks up on fiscal Q1 numbers

July 30, 2014 by Brad Perriello

Haemonetics shares gain slightly after the blood management company beats expectations for its fiscal 1st-quarter sales and earnings.

Haemonetics ticks up on fiscal Q1 numbers

Haemonetics (NYSE:HAE) shares ticked up today after the blood management company beat expectations with its fiscal 1st-quarter results.

FDA cuts fiscal 2015 user fees

July 30, 2014 by Brad Perriello

The FDA is cutting the fiscal 2015 user fees paid by medical device companies to have their products reviewed by 3% across the board.

FDA cuts fiscal 2015 user fees

The FDA is cutting the user fees paid by medical device companies for the watchdog agency's review by some 3% across the board for fiscal 2015.

The FDA's Center for Devices & Radiological Health said today that it proposes to cut the fees for both small businesses making less that $100 million annually and for their larger brethren.

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