Illumina vows to fight EU efforts to block $8B Grail merger

Illumina acquired the liquid biopsy company in 2021, despite pending anti-competitiveness investigations on both sides of the Atlantic.

By Elise Reuter • Updated Aug. 2, 2022

Abortion clinics go mobile, seeking flexibility amid patchwork of state restrictions

Mobile clinics may open the healthcare system to patients barred by state laws from accessing abortion services.

By Rebecca Pifer • Aug. 1, 2022

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

FDA extends Class I UDI submission deadline, exempts consumer health devices from requirements

The deadline extension should help manufacturers submit device identification data to an agency database, while freeing over-the-counter consumer devices from needless regulation.

By Nick Paul Taylor • Aug. 1, 2022

FDA reauthorizes Meridian’s COVID-19 test after changes to enable omicron detection

The renewed emergency use authorization comes as SD Biosensor works to close its $1.53 billion takeover of Meridian.

By Nick Paul Taylor • Aug. 1, 2022

Friday Q&A: Eargo CEO Christian Gormsen talks OTC rule, challenging market leaders, DOJ settlement

New FDA regulations expected soon would boost firms like Eargo, allowing millions of Americans without hearing aids to buy them for less and without a prescription.

By Ricky Zipp • July 29, 2022

LASIK again under microscope as FDA seeks comment on improving patient communication

Amid concerns patients are not receiving information on the risks and benefits of laser eye surgery, FDA’s draft guidance aims to protect consumers.

By Nick Paul Taylor • July 28, 2022

Medtech industry applauds as Senate passes $280B measure to bolster U.S. chip production

Industry leaders say the funding will strengthen U.S. innovation and speed the deployment of life-changing devices to patients.

By Elise Reuter • Updated July 28, 2022

MedTech Europe pushes for semiconductor prioritization as US moves to increase local supply

The trade group wants political action to stop patient harm from “a growing divergence” between semiconductor supply and demand.

By Nick Paul Taylor • July 27, 2022

Biotronik to pay $12.95M to settle kickback allegations of 'lavish' meals, abuse of training programs

Federal prosecutors accused Biotronik of abusing a new employee program by paying physicians to provide “excessive” training and of funding lavish meals.

By Nick Paul Taylor • July 26, 2022

Philips and U.S. Justice Dept. in consent decree talks on sleep apnea, ventilator recall

The company made the announcement Monday during a second-quarter earnings call but provided few details.

By Ricky Zipp , Elise Reuter • Updated July 25, 2022

FDA to expand use of remote regulatory assessments beyond the pandemic

The agency plans to keep using remote assessments, saying they’ve been a “valuable tool” during the pandemic.

By Elise Reuter • July 25, 2022

iRhythm, Alphabet unit Verily get FDA clearances for Zio Watch and software system

Bolstered by an AI algorithm, the companies’ partnership is a step closer to catching up with the Apple Watch.

By Ricky Zipp • July 25, 2022

Test makers urge House, Senate to include diagnostic reforms in user-fee bill

AdvaMedDx, Abbott and Roche are among companies asking lawmakers to address the “urgent public health issue.”

By Nick Paul Taylor • July 21, 2022

Smiths Medical's recall of syringe infusion pumps labeled Class I event after injuries, death

The company is asking customers to return devices if abnormal circuit board behavior causes the pump to stop.

By Nick Paul Taylor • July 21, 2022

FDA patient advisers grapple with consent, oversight of virtual-reality devices in healthcare

The advisory group addressed patient consent in surgeries using augmented reality tools and how to distinguish clinical uses of virtual reality from entertainment products. 

By Elise Reuter • July 20, 2022

Defibrillators, chest drains added to FDA's list of device shortages

The defibrillator supply disruption reflects both increased demand and problems sourcing a component, part or accessory.

By Nick Paul Taylor • July 20, 2022

Notified bodies have yet to issue MDR certificates for 85% of legacy devices: survey

The EU's Medical Device Regulation certification process is taking twice as long as the old directive pathway and smaller companies are struggling to get started, the poll shows.

By Nick Paul Taylor • July 18, 2022

FDA faces furloughs if Senate misses August deadline for user fee bill

If legislation isn’t passed before the August recess, the FDA would have to furlough workers, slowing its review of medical device and pharmaceutical products. 

By Elise Reuter • July 15, 2022

Medtronic warns European healthcare providers of safety problem in defibrillators

The warning adds to Medtronic’s growing list of product safety issues over the last 18 months.

By Ricky Zipp • July 15, 2022

Friday Q&A: Ian Lipkin, Columbia epidemiologist, talks COVID-19 testing as U.S. sees another wave

Lipkin explained why he’s not a fan of antigen tests, and stressed the need to keep PCR testing a core part of the pandemic response.

By Elise Reuter • July 15, 2022

Lack of payment pathway clarity hinders digital therapeutics, analysts say

The report warns of a sector beset by payment issues, “snake oil” and “middling adoption.”

By Nick Paul Taylor • July 15, 2022

EC publishes IVDR guidance in absence of completed Eudamed database

The commission recently announced a timeline for complete implementation of Eudamed, aiming for the second quarter of 2024.

By Ricky Zipp • July 13, 2022

Quest launches monkeypox PCR test as U.S. attempts to catch up with rising cases

The company estimates it will be able to process 30,000 tests per week by the end of July. As of July 12, there were 929 confirmed cases in the U.S., the CDC reported.

By Ricky Zipp • July 13, 2022

Abbott gets FDA breakthrough tag for deep brain stimulation system in depression

The breakthrough device designation builds on a series of clinical trials of other systems that have yielded mixed results.

By Nick Paul Taylor • July 13, 2022

CMS makes 'market-moving proposals' to some medtech Medicare rates, say analysts

BTIG analysts warned in a recent report that the changes “might curtail usage of some higher-dollar” medical devices.

By Nick Paul Taylor • July 12, 2022