Latest Commentary

TEDMED 2015: 23andMe CEO makes the case for DTC genomic testing

It was a triumphant Anne Wojcicki who took the stage at this year's TEDMED conference in Palm Springs, CA. She's had a great year--gaining the first FDA clearance for a direct-to-consumer genetic test earlier this year and recently relaunching a broad consumer test that includes more than 60 points of genetic information including disease carrier status, wellness and disease trait.

Dx Digest: Invitae builds out cancer and epilepsy testing menus; Illumina gets in on autism research

Welcome to Dx Digest, where FierceMedicalDevices highlights the highs and sometimes lows of the past week in the diagnostics industry. Invitae expanded its hereditary cancer and epilepsy test menu; sequencing giant Illumina announced that it would join forces with the Hartwell Foundation's Hartwell Autism Research and Technology Initiative to build the largest shared genomic database for autism; and Thermo Fisher Scientific gained more traction in the companion diagnostics realm.

J&J device heads say the new med tech innovation model calls for more external partnerships

Johnson & Johnson is shaking up its med tech innovation model. Its sprawling medical device unit had a quarterly operational sales increase of just 1.3% to $6.1 billion when adjusting for divestitures and foreign currency fluctuations. Add a negative currency impact to the equation, and the growth rate was -7.3%.

Dx Digest: Roche notches molecular diagnostics sales win; Veracyte CEO lambastes CMS pricing proposals

In this week's Dx Digest, Roche scored FDA approval for its viral load tests and cobas 6800/8800 testing systems and posted stellar sales for its molecular diagnostics unit. Sequenom struck another liquid biopsy clinical research deal. And more.

Dx Digest: FDA signs off on Luminex's genital herpes tests; Roche's Ariosa takes prenatal Dx to Australia

Welcome to the inaugural Dx Digest, where FierceMedicalDevices will highlight the highs and sometimes lows of the past week in the testing industry.

Precedent from Amarin's off-label promotion victory covers devices too, especially those marketing a surrogate endpoint

A recent court ruling inhibiting the FDA from punishing Amarin for off-label promotion deemed truthful and non-misleading shook up the pharma world. The ruling was made for reasons "totally extrinsic to the definition of a drug," and its principles "definitely apply to medical devices," said attorney Coleen Klasmeier in an interview. She heads the food, drug and medical device regulatory practice team at Sidley Austin LLP.

Finding the Fierce: A call for nominations of the top women in med tech

Last year, FierceMedicalDevices debuted its list of top women in med tech. This year we'd like to make it even better. Please let us know who the most important women are in med tech, including medical devices and diagnostics.

Med tech megamergers haven't translated to massive layoffs--at least not yet

None of the giant med tech acquisitions that have closed recently have resulted in a reduction in employee count yet. Not Medtronic-Covidien, Zimmer-Biomet, nor Becton Dickinson-CareFusion. But the rumors are already swirling on where all the anticipated cost savings and reduduncies will be found. That's according to the latest jobs data from EP Vantage.

Go big or go home: A call for 2015 Fierce 15 nominations

We need your help to ferret out the best, most timely examples of med tech innovation. Who has ambition and the potential to make a real leap forward, while being wildly appealing to physicians, patients and payers across a global healthcare environment that is increasingly value-based?

U.S. to vie with India for top bioabsorbable stent market after FDA approval

Bioabsorbable stents are projected to account for 17% of global procedure volume by 2021, up from less than 2% in 2014, said GlobalData analyst Amen Sanghera during a recent webinar. He's a bull on the emerging technology, and estimates a compounded annual growth rate of 56.7% over that time period.