Brexit happened. EU MDR looms. 3 key questions on medtech's future in Europe

The U.K. can skip the new in vitro diagnostic rules entirely, and in theory, could unilaterally stop applying MDR after the transition period ends. Both scenarios seem unlikely.

By Nick Paul Taylor • Feb. 4, 2020

Medtech in limbo as Brexit arrives

Although the industry has lobbied for the departing member state to implement the Medical Device Regulation and stick closely to EU rules, a minister in the U.K. government said legislative alignment “just ain't happening.”

By Nick Paul Taylor • Feb. 3, 2020

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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

Amid coronavirus outbreak, FDA and industry seek roadmap for emergency diagnostics

Taking lessons from the Ebola and Zika crises, regulators and manufacturers are meeting Monday to discuss how real-world data could be used to advance more emergency-use diagnostics to full marketing status.

By Maria Rachal • Updated Jan. 31, 2020

UK moves to mitigate impact of notified body withdrawals

Several firms pulled their services amid uncertainty about the impact of Brexit, bringing risks into focus.

By Nick Paul Taylor • Jan. 30, 2020

CMS widens NGS test coverage for inherited breast, ovarian cancers

The national decision on next generation sequencing tests doesn't go beyond breast and ovarian cancers, but local Medicare contractors are allowed discretion on coverage determinations with other germline cancer diagnoses.

By Maria Rachal • Jan. 28, 2020

Natera takes ArcherDX to court over cancer testing patent

Genetic testing company Natera claims it has exclusive rights to use multiplex PCR in certain cancer settings.

By Nick Paul Taylor • Jan. 28, 2020

CDC urgently working to make coronavirus lab diagnostic available

A Centers for Disease Control and Prevention official told reporters the agency is in the process of growing the virus for further study and working to get laboratory diagnostics to state and local health departments.

By Shannon Muchmore • Jan. 27, 2020

3 more notified bodies coming soon, EC says as MDR clock ticks down

New designations would move the Commission a step closer to its goal of having 20 notified bodies in place by the end of the first quarter of 2020.

By Nick Paul Taylor • Jan. 23, 2020

Abbott ups 2020 growth targets, downplays Libre 2 delay

After exceeding the high end of its 2019 sales forecast on success in electrophysiology, heart failure, structural heart and diabetes, the company forecasts up to an 8% rise in organic growth this year.

By Maria Rachal • Jan. 22, 2020

ArcherDX, Geneoscopy, Phagenesis win breakthrough device designations

A cancer relapse test, a colorectal cancer screening test and a device to restore swallowing control are among the latest technologies to benefit from certain regulatory perks.

By Nick Paul Taylor • Jan. 15, 2020

LabCorp, Quest push for M&A-driven growth despite difficulties closing deals

“It’s still a very fragmented marketplace,” said Quest CEO Steve Rusckowski at JPM. "Trying to get people to move fast has been harder than I would have anticipated,” LabCorp's new CEO Adam Schechter told investors.

By Nick Paul Taylor • Jan. 15, 2020

Nevro, NuVasive, Integra, others preview earnings at JPM

Wednesday's lineup of medtech presenters includes Exact Sciences, Intersect ENT, ICU Medical and handheld ultrasound device maker Butterfly.

By Maria Rachal • Updated Jan. 15, 2020

Adaptive gets CMS coverage for chronic lymphocytic leukemia test

The expanded Medicare policy covers use of the assay in the monitoring of minimal residual disease.

By Nick Paul Taylor • Jan. 9, 2020

CMS delays clinical lab fee schedule data reporting, cuts capped at 15% for 2021

The decision to maintain the status quo comes despite labs hoping the agency would freeze rate cuts next year.

By David Lim • Jan. 3, 2020

Illumina scraps $1.2B PacBio takeover amid regulatory pushback

Cowen analysts listed Agilent, Danaher and Thermo Fisher as potential buyers of Pacific Biosciences.

By Nick Paul Taylor • Jan. 3, 2020

Notified bodies MedCert, BSI gain new EU MDR and IVDR designations

The European Commission's latest nods bring total notified bodies designated for the Medical Device Regulation to nine and for the In Vitro Diagnostic Regulation to three.

By Nick Paul Taylor • Dec. 31, 2019

Myriad wins FDA nod for Lynparza companion diagnostic

The test is meant to identify metastatic pancreatic cancer patients with a germline BRCA mutation who are candidates for AstraZeneca and Merck's pill, the second targeted treatment approved for pancreatic cancer.

By Jonathan Gardner • Dec. 30, 2019

FTC seeks to block Illumina's $1.2B PacBio acquisition over monopoly concerns

Illumina announced Wednesday it will extend the end time of its merger plan with PacBio to March 31, 2020.

By David Lim • Updated Dec. 19, 2019

FDA greenlights first newborn screening test aid for Duchenne muscular dystrophy

Labs now have the option to add the PerkinElmer kit to newborn screening panels, coinciding with a controversial FDA turnaround in approving a new treatment for the rare genetic disorder.

By Maria Rachal • Dec. 12, 2019

EC medical device group sheds new light on MDR, IVDR sampling codes

The Medical Device Coordination Group also issued a guidance explaining codes used to define the scope of a notified body's designation.

By Nick Paul Taylor • Dec. 12, 2019

BioMarin taps Invitae to expand genetic testing for skeletal dysplasia

As it develops drug treatment for a form of skeletal dysplasia, BioMarin is bankrolling a program in which medical genetic testing company Invitae will screen for 109 genes linked to rare bone and joint disorders.

By Nick Paul Taylor • Dec. 11, 2019

Roche MRSA test wins FDA De Novo OK

The agency said the novel diagnostic technology can deliver results in as few as five hours, versus the one to two day wait with conventional methods. 

By Nick Paul Taylor • Dec. 6, 2019

Philips to offer Paige.AI's prostate cancer detection tech

Weeks after Memorial Sloan Kettering Cancer Center spinout Paige.AI won a CE mark for its diagnostic tools, Philips announced it will combine its own digital pathology capabilities with the startup's prostate cancer product.

By Dana Elfin • Dec. 5, 2019

FDA grants breakthrough status to eye-tracking Parkinson's test

The diagnostic test is designed to detect persistent ocular tremors, a symptom research suggests appears early and is pervasive in Parkinson's patients.

By Nick Paul Taylor • Dec. 4, 2019

MRI screening linked to improved detection of breast cancer

The New England Journal of Medicine study found fewer cases of cancer are missed when MRIs are performed. At the same time, the scans come with a high rate of false positives, calling the utility of additional imaging into question.

By Nick Paul Taylor • Dec. 2, 2019