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In Massachusetts governor's race, the medical device tax has no friends

September 30, 2014 by Brian Johnson

Candidates in the race for Massachusetts governor race tell MassDevice.com that they're for a repeal of the medical device tax and would support exploring a potential offset for Bay State medtech companies.

In Massachusetts governor's race,the medical device tax has no friends

The next Massachusetts governor won't be spending any political capital defending the medical device tax, a 2.3% excise tax on U.S. medtech sales. Both of the leading candidates told MassDevice.com yesterday that they would push for a federal appeal and consider a tax credit to offset the levy.

Studies criticize U.S. medical device approval process

September 29, 2014 by MassDevice

The FDA's less-stringent 510(k) clearance process comes under fire (again) in a pair of new studies.

Studies criticize U.S. medical device approval process

NEW YORK (Reuters Health) - Information on the safety and effectiveness of medical devices before and after they are cleared by U.S. health regulators can be improved, according to 2 new studies.

Tengion is on the auction block

September 29, 2014 by Alexander Soule

Tengion puts itself and its organ regeneration technology on the auction block, hiring Jefferies LLC to explore "strategic alternatives."

Tengion, TNGN, Jefferies, organ regeneration, kidney

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Tengion (NSDQ:TNGN) said it's hired Jefferies to assess "all strategic alternatives," corporate shorthand for putting the Winston-Salem, N.C.-based company and its organ regeneration technology on the auction block.

Mitralign reports 1st-in-human tricuspid valve repair

September 29, 2014 by Alexander Soule

Mitralign reports the 1st-in-human use of its minimally invasive device to treat tricuspid valve regurgitation under a compassionate use allowance in Germany.

Mitralign reports 1st-in-human tricuspid valve repair

Mitralign said today that surgeons in Germany implanted its tricuspid valve repair device in its 1st patient, under a "compassionate use" allowance in Germany.

Cohealo raises $3m for medical device sharing software

September 29, 2014 by Alexander Soule

Cohealo reports a $3.2 million debt round for the software it's developing to help hospitals manage their shared medical device inventory.

Cohealo raises $3m for medical device inventory management solution

Cohealo reported raising $3.1 million of a hoped-for $5.8 million in debt financing as it develops software to help hospitals manage their shared medical device inventory.

MassDevice.com +3 | The top 3 medtech stories for September 29, 2014

September 29, 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.

 

CVRx wins heart failure CE Mark for Barostim Neo neurostim device

September 29, 2014 by Brad Perriello

CVRx adds CE Mark approval for treating heart failure patients to its European Union approval for hypertension treatment using its Barostim Neo device.

CVRx said today that it won CE Mark approval in the European Union for its Barostim Neo device to treat heart failure patients using vagus nerve stimulation.

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