Policy & Regulation

FDA categorizes Cordis catheter recall linked to 8 injuries as Class I event

The recall comes a decade after Cordis flagged up the potential for marker bands to dislodge into the vascular system when the catheter is stretched.

By Nick Paul Taylor • Sept. 23, 2021

EU threatens Illumina for closing $8B Grail deal while still under review

The European Commission's warning of fines and other measures is another step in a saga that could run for years. If the bloc ultimately opposes the acquisition, the path forward will be through the courts.

By Nick Paul Taylor • Sept. 22, 2021

Explore the Trendline➔

Trendline

How medtechs are navigating the sales environment through the pandemic

The impact of the pandemic on the industry was far from even, given the diversity of companies in the space — from those that make heart valves to artificial hips and knees to robotics to point of care testing.

By MedTech Dive staff

Paige's AI-based software gets FDA nod to help doctors identify prostate cancer

It's the latest in a series of milestones for the startup, which has picked up 510(k) clearance for its image viewer, raised more than $220 million and partnered with Philips and Quest Diagnostics in recent years.

By Nick Paul Taylor • Sept. 22, 2021

Medtronic embolization device hit with another Class I recall, 2 deaths cited

The action expands a 2020 recall of the brain aneurysm treatment and comes five months after the agency approved an updated version of the technology.

By Susan Kelly • UPDATED: Sept. 22, 2021 at 8:55 a.m.

Abbott gets FDA nod, faces uphill climb taking on Edwards, Medtronic in TAVR market

The challenge for Abbott as the newcomer is to take share in a relatively mature market dominated by well-set incumbents, without evidence of superiority.

By Nick Paul Taylor • Sept. 21, 2021

UK seeks overhaul of AI, software as a medical device regs

The Medicines and Healthcare products Regulatory Agency is slightly ahead of the FDA, which plans to publish draft guidance for AI and SaMD this year.  

By Greg Slabodkin • Sept. 20, 2021

FDA policy in response to COVID-19 offers blueprint for regulation of LDTs: study

The agency's response to the pandemic showed it can oversee lab-developed tests, according to Massachusetts General Hospital researchers. They contend that their study could inform legislation aimed at regulating such diagnostics.

By Nick Paul Taylor • Sept. 17, 2021

FTC warns app makers fall under breach notification rule

The agency noted that developers of health apps and connected devices are considered healthcare providers. Any unauthorized access, including sharing information without consent, would trigger the Health Breach Notification Rule.

By Shannon Muchmore • Sept. 16, 2021

FDA creates new office to drive forward digital transformation strategy

Vid Desai, who will help lead the new Office of Digital Transformation, was also named as the agency's chief information officer. FDA is seeking an extra $75.9 million in the 2022 budget to support the modernization plan.

By Nick Paul Taylor • Sept. 16, 2021

CMS moves to scrap MCIT rule due to clinical evidence concerns

AdvaMed said the repeal of the Medicare Coverage of Innovative Technology rule is the wrong decision for patients. Analysts wrote the breakthrough device pathway could be resurrected in Cures 2.0 legislation. 

By Nick Paul Taylor • Sept. 14, 2021

Deep Dive

Medtechs are boosting DTC investment, but industry still years behind pharma

Companies are spending hundreds of millions of dollars every year on direct-to-consumer advertising as the industry focuses on marketing more to patients.

By Ricky Zipp • Sept. 14, 2021

MedTech Europe calls for urgent clarification of EU artificial intelligence proposal

The trade group worries "unnecessary overlaps" between the proposed AI Act and medical device regulations, such as MDR and IVDR, could affect access to products as well as lead to legal uncertainty.

By Nick Paul Taylor • Sept. 13, 2021

Abbott, Quest, Quidel likely to benefit from Biden's COVID-19 testing push

Using the Defense Production Act, the White House will push for expanded test production, with $2 billion earmarked to buy nearly 300 million rapid antigen tests for schools, health centers and food banks.  

By Greg Slabodkin • Sept. 10, 2021

FDA ends summer with fresh batch of breakthrough device designations

Novocure and CellMax Life are among the latest to get regulatory privileges for experimental devices used to treat and detect cancers.

By Nick Paul Taylor • Sept. 10, 2021

Spine devices, recalls and endovascular stents on FDA's fall meeting lineup

Other topics include Integra's bid for approval of a device used as soft tissue support in post-mastectomy breast reconstruction and a workshop on artificial intelligence and machine learning. 

By Nick Paul Taylor • Sept. 08, 2021

Feds sue UPMC heart surgeon for billing multiple surgeries at same time

The False Claims Act litigation also accuses the health system of ignoring or minimizing complaints by employees and staff.

By Ron Shinkman • Sept. 07, 2021

TransMedics wins FDA nod for donor heart preservation system

Approval for the device comes two months after an FDA advisory panel backed the company's liver preservation system and follows the go-ahead for its donor lung technology in 2019.

By Susan Kelly • Sept. 07, 2021

EU expert panel starts accepting applications to review high-risk IVDs

The incoming IVD regulation, set to go into effect next May, requires certain diagnostics be reviewed by the committee and/or tested by a reference lab.

By Nick Paul Taylor • Sept. 07, 2021

Q&A

ECRI CEO: FDA, industry must revisit COVID-19 medical device EUAs as shortages ebb

Marcus Schabacker spoke to MedTech Dive about patient safety, cyberattacks in healthcare and risks from the rise of at-home care.

By Ricky Zipp • Sept. 03, 2021

Medicare insolvency still expected by 2026, unchanged by COVID-19, trustees say

The forecast is a bit of a bright spot for the otherwise grim financial prospects of the program, as experts worried COVID-19 would result in the fund that finances Medicare Part A running out of money faster than previously expected.

By Rebecca Pifer • Sept. 03, 2021

FDA restarts distribution of Lilly's COVID-19 drug in 22 states

Use of the treatment had been halted due to weakened efficacy versus an early coronavirus variant. Now, with delta widely prevalent and demand for antibody treatments surging, Lilly's therapy will be available again. 

By Shoshana Dubnow • Aug. 31, 2021

Top FDA vaccine officials to leave agency as decision on COVID-19 boosters looms

Marion Gruber and Phil Krause, veteran vaccine reviewers, are unexpectedly departing at a critical time. The search for their replacements will begin "imminently," division head Peter Marks said in a letter.

By Ben Fidler • UPDATED: Aug. 31, 2021 at 3:14 p.m.

Zimmer 'smart knee' gets FDA nod as ortho rivalry with Stryker heats up

The orthopaedics device maker, through a collaboration with Canary Medical, becomes the first company to bring an implantable smart device for total knee replacement to the U.S. market.

By Susan Kelly • Aug. 31, 2021

BD gets emergency FDA nod for smartphone-enabled COVID-19 test

The medtech is launching the product against a backdrop of rising demand for similar diagnostics, as the delta wave spurs a surge in cases nationwide after a pullback in the first part of the year.

By Nick Paul Taylor • Aug. 27, 2021

Medtechs made it out of Q2 with minimal impact from delta. That could change in Q3.

After procedure-dependent medtechs reported strong elective returns in the first half of 2021, the delta variant is now posing a risk to the industry's recovery as hospitals once again shut down procedures.

By Ricky Zipp • Aug. 26, 2021