News

Why are so many companies failing to pay the device tax?

The 2.3% medical device excise tax raised $913 million in the first half of 2013, or about 75% of what was anticipated. A look at the number of filers reveals a large part of the problem. Out of estimates as high 15,000 only 5,107 medical device tax forms were filed.

Dartmouth mobile app detects depression and stress levels

Lonely, depressed, stressed? There's a smartphone app that can read your mood like a book. At Dartmouth, student researchers developed and tested StudentLife, an app that can detect depression and stress levels.

University of Louisville working on 'bioficial heart' using 3-D printing

Researchers at the University of Louisville say they are closing in on being able to conduct human clinical trials of implanting prevascularized patches for the heart that are created through 3-D bioprinting technology they developed.

Physicians defend power morcellator devices amid industry fallout

Amid mounting regulatory and industry criticism for gynecological tools used in minimally invasive procedures, physicians continue to defend the devices as a viable surgical option.

Apple HealthKit delayed by bug as major EHR players commit

The health revolution has been put on hold. The long-awaited HealthKit from Apple will take a few weeks longer. Instead of launching as expected on Wednesday, due to a bug its debut has been pushed to the end of September, Reuters reports. The health and fitness application platform is expected to allow consumers and healthcare providers to better track, access and share health data.

Med tech veteran, Venture Valkyrie offers healthcare prescriptions

Health care venture capitalist, Lisa Suennen shared her take on what it would take to improve the situation. She recommends inexpensive new outpatient monitoring technologies, regulatory adjustments to encourage the system to play fair and more transparency in medical pricing, as well as patient education based of behavioral economics to help people take care of their own health.

British startup launches crowdfunding effort for 3-D printed orthotic devices

As 3-D printing gains traction within the industry, British startup Andiamo is launching a crowdfunding effort to develop 3-D printed orthotic devices for disabled children.

UDI architect shares compliance tips on eve of regulation's first deadline

"Mr. UDI" gave industry advice on complying with the complex unique device identification rules as medical device companies barrel toward the Sept. 24 deadline for adding identifiers to high-risk devices. Former FDA official Jay Crowley has acquired the nickname for his role in implementing and designing the UDI system. He is now a consultant for USDM Life Sciences.

Court ruling against FDA enables more combination products to be classified as devices

The U.S. District Court for the District of Columbia rejected the FDA's attempt to classify Prevor's Diphoterine Skin Wash as a drug rather than a device for the second time, dealing industry a victory in the sometimes contentious arena of product classification decisions.

Zimmer partners with MiMedx to sell bioimplants to promote healing

MiMedx Group announced a second partnership with a major medical device firm to sell its regenerative biomaterials product. This time, it is with orthopedic player Zimmer. Last year, MiMedx disclosed a similar deal with Medtronic.

Intrinsic raising $21M for implant to improve lumbar disc surgery

Intrinsic Therapeutics is aiming at more effective surgical treatment of lumbar disc herniation and is in the process of raising almost $21 million in venture capital, according to a Sept. 17 SEC filing.

23andMe customers must now opt in to find unknown close relatives via genetic test

Genetic testing company 23andMe--famous for getting on the bad side of the FDA--is reversing a planned policy that would automatically opt in customers to its close relatives program, which meant that by sending a saliva sample in for DNA analysis they could discover an unknown relative out of the blue. 

Medical device excise tax repeal heats up in U.S. House

Minnesota Representative Erik Paulsen is taking another swing at the medical device excise tax implemented with the Affordable Care Act. Repealing the 2.3% tax is being brought back up in the House of Representatives.

Mainstay Medical bucks M&A trend, sets own course for neuromodulation

Amid a wave of med tech M&A, Irish startup Mainstay Medical is bucking the trend and charting its own course to bring its innovative neuromodulation device to market.

Study: PET-CT scan better than CT scan in predicting relapse of follicular lymphoma

Positron emission tomography/computed tomography rather than conventional CT scanning should be used to image and assess follicular lymphoma, concludes a study in The Lancet Haematology.

Researchers develop the first blood test to diagnose adult depression

Researchers have identified 9 RNA blood markers that can be used as part of a panel to diagnose depression. They said it is the first blood test to diagnose adult depression.

Study finds no benefit from new implants over older versions

An analysis of outcomes data found that there is little to no support for new joint replacements in comparison to their predecessors. 

Medtronic unloads instrument lines to Integra for $60M

In its latest product acquisition, Integra LifeSciences is buying instrumentation lines from Medtronic for $60 million in cash. These include about 4,000 MicroFrance and Xomed manual ENT and laparoscopic surgical instruments. The surgical products company will also gain a manufacturing facility in St. Aubin le Monial, France.

Providence Health launches $150M venture fund

Providence Health & Services, a non-profit care ministry dedicated to improving quality of home healthcare, hospice, and elderly care, launched a venture capital fund to improve innovations across the health care system for patient care. Over the next 5 to 7 years, Providence Ventures will invest $150 million towards innovations.

FDA greenlights first human study of Wearable Artificial Kidney

Months after clearing the Wearable Artificial Kidney for human clinical trials, the FDA gave medical researchers a green light to begin the first human study of the device in the United States.