FDA calls device manufacturing expert meeting to discuss quality system harmonization

After the agency began transitioning its Quality System Regulation in 2018, the public may finally get to see the proposed rule in late February or early March.

By Nick Paul Taylor • Feb. 18, 2022

EU issues guidance on high-risk IVDs, surveillance of legacy medical devices

The documents outline how notified bodies can meet In Vitro Diagnostic Medical Devices Regulation requirements to verify product batches of high-risk class D diagnostics, and manufacturer rules on quality management systems.

By Nick Paul Taylor • Feb. 17, 2022

Explore the Trendline➔

New medical devices are reshaping the medtech industry

From pulsed field ablation devices to glucose sensors and surgical robotics, new medical technologies are transforming patient care and how people manage their health.

By MedTech Dive staff

Illumina continues to battle EU regulators over premature $8B Grail buy

CEO Francis deSouza told MedTech Dive that Illumina continues a two-front defense in the European Union — in the courts and with regulators — over its early acquisition of the cancer diagnostics test maker. 

By Greg Slabodkin • Feb. 16, 2022

Califf's confirmation comes as FDA, medtechs skirmish over regulations

Industry groups, including AdvaMed, congratulated Robert Califf on his confirmation as FDA commissioner. But they're still negotiating with the agency over medical device user fees and lab-developed tests.

By Jonathan Gardner • Updated Feb. 16, 2022

Latest Essure data show more patients had device removed

According to the latest results from two FDA postmarket studies, the number of people who had the birth control implant removed or experienced chronic pain increased. 

By Nick Paul Taylor • Feb. 15, 2022

CDRH digital health chief talks new role with agency, future of the market

Bakul Patel, the Center for Devices and Radiological Health's chief digital health officer, will help FDA meet its 2022-2025 strategic priorities and set regulatory policies for the new technologies such as AI and machine learning.

By Elise Reuter • Feb. 14, 2022

Senseonics glucose monitor approval overshadowed by 'eye popping' fall in sales forecast

"Some change was expected given COVID delays, though we struggle to understand why the guide assumes zero growth at the low-end, particularly with a brand-new product approved," Craig-Hallum analysts wrote.

By Nick Paul Taylor • Feb. 14, 2022

Hospital leaders, Congress mull fixes to current staffing woes

The omicron variant is posing new challenges as staff call in sick or quit their jobs entirely for higher-paying traveling nurse positions. That's leaving hospitals in a bind as they treat higher acuity COVID-19 patients.

By Hailey Mensik • Feb. 11, 2022

Dexcom's G7 gains CE mark after 2021 delay

The company’s newest continuous glucose monitoring system was expected to launch in Europe in 2021, but regulatory delays pushed the release back.

By Ricky Zipp • Updated March 14, 2022

FDA plan to harmonize device quality system rules clears OMB review

The White House's Office of Management and Budget review positions FDA to publish a long-awaited proposed rule that is intended to bring the agency's quality system rules in line with international standards.

By Nick Paul Taylor • Feb. 10, 2022

BioCardia, Cook Medical land FDA breakthrough nods in latest designations

Cardiovascular devices feature prominently in the tech granted regulatory privileges, including a drug-eluting stent for patients with chronic limb-threatening ischemia and a non-invasive cardiac monitoring device. 

By Nick Paul Taylor • Feb. 9, 2022

Roche partner recalls illegally imported rapid COVID-19 tests from US

FDA said there are "confirmed reports" of unlawful importation of the Standard Q COVID-19 Ag Home Test and South Korea's SD Biosensor is looking into which distributors or people were involved.

By Nick Paul Taylor • Feb. 7, 2022

Procedure volatility, testing uncertainty & FDA delays: Medtech trends in 2022

As companies manage through the omicron surge, and with the threat of potential future variants, the medical device industry is facing another challenging year.

Feb. 4, 2022

CDRH targets hiring, novel approvals among 2022-2025 strategic priorities

FDA's Center for Devices and Radiological Health, whose staff continues to struggle with an unprecedented workload since the pandemic's start, is aiming to achieve at least 90% of its annual hiring targets for certain years.

By Nick Paul Taylor • Feb. 4, 2022

Breakthrough device program 'far exceeding' FDA expectations after record year

The total number of products granted the agency's regulatory privileges in 2021 increased by more than 50%, while the number of novel devices that came to market fell compared to 2020.

By Nick Paul Taylor • Feb. 1, 2022

3 key FDA topics for medtechs in 2022

While the agency is looking to get back to normal operations this year, COVID-19 is poised to remain a top priority and, once again, thin resources for more traditional work, such as product reviews.

By Ricky Zipp , Greg Slabodkin • Feb. 1, 2022

FDA must improve medical device interoperability through data standards: JAMA

The authors list a range of potential positive outcomes of improved device interoperability, using the experience of the consumer technology and telecommunications industries to make their case.

By Nick Paul Taylor • Jan. 31, 2022

Senators urge FDA to finalize over-the-counter hearing aid rule

Sen. Elizabeth Warren, D-Mass., and Sen. Chuck Grassley, R-Iowa, are asking the FDA to finalize a rule that would create a class of over-the-counter hearing aids, without implementing changes suggested by manufacturers. 

By Nick Paul Taylor • Updated Feb. 9, 2022

3 key labor trends for hospitals in 2022

Hospitals are still grappling with rising turnover, widespread burnout and numerous staff calling in sick nearly two years after the pandemic began. It's unclear when it might get better — or how much worse it could get.

By Hailey Mensik • Jan. 27, 2022

Philips' problems grow as FDA labels expanded ventilator recall Class I event

The agency's new notice expands the company's June recall, which has grown to over 5 million affected devices. Jefferies analysts said it is "immaterial to financials but will negatively impact sentiment."  

By Nick Paul Taylor • Jan. 27, 2022

4 key trends for procedure-reliant medtechs in 2022

Medical device companies likely will face the same challenges this year that they have been dealing with since the pandemic's start, such as procedure volatility and hospital staffing shortages.

By Ricky Zipp • Jan. 27, 2022

FDA finalizes two guidances on including patient perspectives in medtech clinical trials

The documents, which elaborate on how to engage patients to improve trial design and use patient-reported outcomes, are based on feedback from groups like AdvaMed which raised concerns about "significant" legal issues.

By Nick Paul Taylor • Jan. 26, 2022

J&J's device recovery slowed by omicron surge, with impact expected over next several months

CFO Joseph Wolk said that the medtech giant expects pressure from COVID-19 and hospital staffing shortages to continue through the first half of 2022, with businesses recovering month by month.

By Ricky Zipp • Jan. 25, 2022

Medtronic gets earlier-than-expected FDA approval for pain device, raising concerns among Nevro investors

The premarket approval, which Medtronic wasn't expected to seek until 2023, positions it to compete with Nevro for a market it values at $1.8 billion.

By Nick Paul Taylor • Jan. 25, 2022

Medtronic's HawkOne recall labeled Class I, adding to medtech's product safety problems

FDA posted 10 Class I recall notices for Medtronic in 2021 and three so far this year. CEO Geoff Martha addressed the recalls and an FDA warning letter at the J.P. Morgan conference, claiming the company will increase accountability.

By Ricky Zipp • Jan. 21, 2022