FDA clears first rapid Ebola virus diagnostic

Risk of flare up remains, but the United Nations called the outbreak responsible for killing 2,100 people over 14 months in the Democratic Republic of the Congo "significantly contained."

By Nick Paul Taylor • Oct. 11, 2019

CDS software, labels for staplers and breast implants among FDA 2020 guidance priorities

The annual publication comes days after the White House issued an executive order aimed at limiting agency use of the documents.

By David Lim • Oct. 11, 2019

Explore the Trendline➔

Medical device industry continues to turn to AI

While the industry continues to embrace artificial intelligence, there are still questions about how the new technologies need to be regulated and if they are effective.

By MedTech Dive staff

Experimental cancer IVD trial guidance finalized

AdvaMed won many many of the changes it sought during the comment period, including ones related to communication with the FDA.

By Nick Paul Taylor • Oct. 10, 2019

Fresenius to pay $5.2M to settle Medicare overbilling allegations

DOJ alleged the company overbilled Medicare for more than seven years by ordering hepatitis B tests for patients it knew to be immune to the virus.

By Nick Paul Taylor • Oct. 10, 2019

Qiagen taps new CEO, restructures in 'clearly a bad day'

The company is also suspending next-generation sequencing-related instrument development as it pivots into a 15-year partnership with Illumina to develop in vitro diagnostic kits.

By David Lim • Oct. 8, 2019

Lantheus strikes deal to buy Progenics, sparking investor backlash

Velan Capital, a big shareholder in Progenics, accused management of selling at a "massive discount" and preventing investors from being heard.

By Nick Paul Taylor • Oct. 3, 2019

Former Covance CEO out as LabCorp diagnostics chief a month after appointment

Newly minted diagnostics CEO John Ratliff is departing the company. LabCorp reshuffled two supply chain and managed care execs to fill the void.

By David Lim • Updated Nov. 7, 2019

FDA designates AI software meant to boost ultrasound accessibility a breakthrough device

Led by Livongo and 23andMe veteran Andy Page, newly rebranded Caption Health anticipates pivotal data on its tech will be published in early 2020."

By Maria Rachal • Oct. 1, 2019

DOJ charges 35 people in $2.1B Medicare genetic testing fraud scheme

CMS also announced it took adverse administrative action against CGx testing companies and providers who filed more than $1.7 billion in claims to Medicare.

By David Lim • Sept. 30, 2019

AI just as effective as docs in medical imaging, study suggests

Still, researchers cautioned that the data is sparse and warned against sweeping conclusions, noting "the narrow public body of work comparing AI to human physicians."

By Rebecca Pifer • Sept. 25, 2019

EU changes for IVDs called a 'sea change,' revolutionary

The new in vitro diagnostic regulation, slated to come into effect May 2022, will for the first time subject as many as 90% of these diagnostics to review. Previously, most companies could self-certify.

By Dana Elfin • Sept. 23, 2019

Medtechs keep shareholders happy, potentially at pipeline's expense: EY

The industry recorded its highest revenues ever within the last year, an analysis by the consultancy shows. Even as R&D spending grew 11%, those investments fell short of the proportion of cash returned to investors.

By Maria Rachal • Sept. 23, 2019

FDA lowers Cologuard age to 45, adding 19M to Exact's screening market

The labeling change, which some analysts say represents a more than $3 billion annual revenue opportunity, brings Exact Sciences' flagship product in line with updated screening guidelines for colorectal cancer.

By Maria Rachal • Sept. 23, 2019

Adaptive lands deal to provide NGS-based cancer tests to Amgen

The giant biotech will pay annual development fees, sequencing payments and regulatory milestones that could amount to a notable source of revenue for Adaptive.

By Nick Paul Taylor • Sept. 19, 2019

Quest didn't steal Cedars-Sinai blood test in trade secrets row, jury says

Hospitals are increasingly using intellectual property to spur transition of early-stage discoveries into products that can be commercialized through licensing agreements.

By Dana Elfin • Sept. 16, 2019

Nurses, physician assistants rarely interpret diagnostic images, study finds

Researchers at Emory University said the analysis suggests a need for standardized, focused training programs for non-physician professionals to formally define their roles.

By Susan Kelly • Sept. 16, 2019

Abbott says AI technology can help diagnose heart attacks

A study in the journal Circulation concluded the algorithm, which aims to individualize testing by taking into account factors such as patient age and sex, performed better than the European Society of Cardiology rule-out pathway.

By Susan Kelly • Sept. 11, 2019

FDA finalizes guidance on HDEs after AdvaMed scrutiny

Industry advocates had criticized FDA's tight parameters on which humanitarian use devices are eligible to turn a profit, but the final guidance largely mirrors the draft.

By Susan Kelly • Sept. 6, 2019

Prescient gets FDA breakthrough status for colorectal cancer test

If eventually approved, the test's competition includes Exact Sciences' Cologuard and an older test for blood in fecal samples.

By Nick Paul Taylor • Sept. 5, 2019

Laboratory for Advanced Medicine's liver cancer test gets FDA breakthrough tag

The company secured the status after showing the test detects hepatocellular carcinoma with a specificity and sensitivity in excess of 95%.

By Nick Paul Taylor • Sept. 4, 2019

Abbott touts potential of 15-minute concussion detection

Highlighting research from the TRACK-TBI study, the company said its in-development point-of-care test could help diagnose concussion in patients whose CT scans miss signs of mild traumatic brain injury.

By Maria Rachal • Aug. 27, 2019

Pharmacogenetic test makers cheer UnitedHealth coverage. Other payers aren't there yet.

"I've been concerned that the hype around pharmacogenetics, at least for depression, has gotten out ahead of the data," James Potash, director of psychiatry at the Johns Hopkins University, said.

By Graison Dangor • Aug. 27, 2019

Lawmakers to update VALID this fall, but industry still clashing over details

With Republican Sen. Richard Burr as a new lead sponsor, Congress is working toward releasing an updated Leading-edge IVCT Development Act in the coming months, multiple sources familiar with the issue told MedTech Dive.

By David Lim • Aug. 26, 2019

Medicare draft decisions may boost Natera, Myriad tests

Cowen analysts called proposed local coverage for Natera's colorectal cancer test as "materially broader and quicker than expected," while documents on pharmacogenomic tests gave a mixed outlook for Myriad Genetics' products.

By Nick Paul Taylor • Aug. 23, 2019

FDA scolds diagnostic manufacturer over production practices

An early 2019 inspection of Polymer Technology Systems' operations prompted regulators to conclude the company had failed to inform FDA of certain reportable events, among other production process shortcomings.

By Nick Paul Taylor • Aug. 22, 2019