MedPAC says lower clinical lab fees don't impact access, prompting ACLA ire

The clinical laboratory group, whose members include Quest and LabCorp, contends that MedPAC's report to Congress contains "biased" commentary that ignores the value of lab tests and importance of timely patient access.

By Nick Paul Taylor • June 16, 2021

FDA advisory panel to review TransMedics' liver preservation device

The Gastroenterology and Urology Devices Panel will meet virtually on July 14 to discuss the company's filing for premarket approval of the OCS Liver system, which is designed to keep donor organs viable for longer.

By Nick Paul Taylor • June 15, 2021

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

ResMed's stock climbs following Philips' sleep apnea, ventilator device recall

Wall Street analysts wrote the recall could drive patients and durable medical equipment providers to ResMed devices, though any benefits right now are "impossible to quantify."

By Ricky Zipp • Updated June 16, 2021

FDA rejects Verily filing for wrist-worn Parkinson's clinical trial device

The sister company of Google developed the feature to collect data on the motor function of Parkinson's patients in between visits to trial sites. However, the agency questioned the wearable's ability to have a meaningful effect. 

By Nick Paul Taylor • June 14, 2021

EC issues medtech guidance on implant cards required under MDR

The European Commission detailed information implant manufacturers need to provide under the new rules, while also publishing a document on the European Medical Device Nomenclature and how it relates to IMDRF terminology.

By Nick Paul Taylor • June 14, 2021

FDA blasts Innova for shipping unapproved COVID-19 test, using false or misleading labeling

The agency hit the California-based medtech with a flurry of actions on Thursday, firing off a warning letter alongside notice of a Class I recall and a press release telling the public to stop using the antigen test. 

By Nick Paul Taylor • Updated June 11, 2021

Medtronic's FDA approval sets up fight for recharge-free pain market

The medtech sees Vanta helping it gain share in a market it has struggled to penetrate in the past. Abbott Laboratories, Boston Scientific and specialist spinal cord stimulation rival Nevro are also competing.

By Nick Paul Taylor • June 11, 2021

HHS warns providers, insurers COVID-19 testing must be free for patients

The American Clinical Laboratory Association, which includes Quest Diagnostics and LabCorp, has complained that guidance on the topic had only served to muddy what they saw as clear congressional mandates.

By Greg Slabodkin • June 10, 2021

EU provides plan to meet 'serious challenge' of readiness for IVDR

The document by the Medical Device Coordination Group is designed to ensure "limited resources" are focused on the activities that are critical to being ready by May 2022.

By Nick Paul Taylor • June 10, 2021

FDA lays out device cybersecurity efforts as feds look to implement Biden executive order

The president signed an order last month seeking to bolster the nation's cyber posture amid growing threats from hackers. 

By Greg Slabodkin • June 9, 2021

'Covid hangover' to spur health costs to rise 6.5% in 2022, PwC poll predicts

PwC found, however, that a greater reliance on lower-cost sites of care like virtual visits and retail clinics could help offset higher usage of medical services.

By Hailey Mensik • June 9, 2021

Amazon offers COVID-19 test online to consumers with a website for viewing results

The tech giant's coronavirus diagnostic, which received FDA emergency authorization in March, was originally designed for use by company employees but is now available for $39.99 to the public.

By Nick Paul Taylor • Updated June 16, 2021

OraSure gets EUAs to enter shrinking COVID-19 antigen test market

The technology is differentiated from other rapid antigen tests but is coming to market amid what Abbott characterized as a "sharp and rapid" drop in demand.

By Nick Paul Taylor • June 8, 2021

Medtronic's HeartWare HVAD ending brings questions about $1B acquisition

Nearly five years after Medtronic's buy of HeartWare International, the medtech giant pulled the flagship product of the deal due to safety risks, ceding the market to rival Abbott.

By Ricky Zipp • June 8, 2021

Medtronic lands FDA approval for brain stimulation leads it expects to drive share gains

CEO Geoff Martha has boasted the nod for SenSight will help it close "a key competitive gap." The medtech competes with Abbott and Boston Scientific in the market. 

By Nick Paul Taylor • June 8, 2021

Cancer tech dominates FDA's latest batch of breakthrough devices

The agency's recent breakthrough designations feature a clutch of oncology devices and diagnostics from companies including Viome and Avenda Health.

By Nick Paul Taylor • June 7, 2021

UnitedHealthcare to crack down on ER visits, potentially exposing patients to bigger bills

If the largest private payer finds the trip was not an emergency, the visit will be "subject to no coverage or limited coverage," the provider alert states. Anthem faced backlash for a similar policy several years ago. 

By Samantha Liss • June 4, 2021

CMS' Fowler: More mandatory payment models likely

"I recognize those come with their own set of disadvantages ... But I support this direction," CMMI head Elizabeth Fowler said Thursday.

By Rebecca Pifer • June 3, 2021

Medtronic pulls HeartWare HVAD pump from market amid recalls, patient deaths

The medtech said the move was influenced by growing evidence the system had higher mortality risks than comparable devices. FDA advised providers to use Abbott's HeartMate 3 as an alternative.

By Ricky Zipp • June 3, 2021

FDA warns device makers of falsified records at Italian ethylene oxide sterilization facilities

BD and Medtronic are among those that already recalled products processed by Steril Milano, accused by the agency of falsifying graphs and parameters of sterilization certificates for a variety of products dating back to 2016.

By Nick Paul Taylor • June 3, 2021

Cognoa's machine learning software for autism diagnosis gets FDA nod

The software as a medical device, which uses an algorithm, reports a positive or negative diagnosis based on analyses of videos of the child and other information. The product got FDA's breakthrough designation in early 2019.

By Nick Paul Taylor • June 3, 2021

In first, FDA approves KRAS-blocking cancer drug from Amgen

After decades of scientists unsuccessfully targeting the KRAS gene, Lumakras is the first drug proven effective. The FDA Friday also approved companion diagnostics from Qiagen and Guardant Health.

By Ned Pagliarulo • Updated May 29, 2021

FDA seeks 8% budget boost for CDRH to back resurgence of domestic device production

The Biden administration said its request for the Center for Devices and Radiological Health will help the U.S. reduce reliance on products from China and other countries and strengthen its ability to respond to emergencies.

By Nick Paul Taylor • June 1, 2021

ACLA appeals dismissal of PAMA lawsuit, pushes legislative fixes

The lab trade group for Quest, LabCorp and others argues the Protecting Access to Medicare Act is a case of "harmful regulatory overreach" that forces an "unsustainable reimbursement model" on its members.

By Nick Paul Taylor • June 1, 2021

Swiss medtech sounds alarm as MDR erects barriers to EU market

The Swiss Medical Technology Association said the change will cost the industry it represents the equivalent of $126 million to meet new administrative requirements.

By Nick Paul Taylor • May 28, 2021