FDA's performance against MDUFA IV decision goal falls to new low

The agency's premarket approval target is set to slump, with the current figure for fiscal 2021 sitting almost 20% below the prior full-year low. FDA warned in September it may not "make good" on some MDUFA IV commitments.

By Nick Paul Taylor • March 1, 2022

Medtech, hospitals on alert for cyberattacks after Russia's invasion of Ukraine

While cybersecurity threats to healthcare and medical devices have grown during the pandemic, the Russia-Ukraine conflict has raised the threat level, putting patient safety at risk.

By Greg Slabodkin • Feb. 28, 2022

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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

HHS sets out plans to make medical device, diagnostics supply chains pandemic-proof

The U.S. Department of Health and Human Services wants to shore up the public health supply chain by investing in personal protective equipment, durable medical equipment and testing. 

By Nick Paul Taylor • Feb. 28, 2022

DOJ moves forward with suit to block UnitedHealth's acquisition of Change

The lawsuit alleges that if UnitedHealth acquired Change, the payer would be able to gain a competitive advantage by seeing "very competitively sensitive" data from other insurers.

By Shannon Muchmore • Feb. 25, 2022

CMS code seen as major step toward reimbursement for digital therapeutics

Pear Therapeutics CEO Corey McCann said the agency's new HCPCS code for prescription digital behavioral therapy is an important milestone for getting digital therapeutics as a product category covered by more insurance plans. 

By Elise Reuter • Feb. 25, 2022

Roche's Foundation Medicine gets FDA breakthrough device nod in latest designations

Breakthrough status was granted to Foundation Medicine's test to detect molecular residual disease in early-stage cancer after curative therapy. A liquid biopsy from Datar Cancer Genetics was also given the regulatory privileges.

By Nick Paul Taylor • Feb. 25, 2022

Baxter hit with $18M SEC penalty for accounting improprieties

The U.S. Securities and Exchange Commission settled charges and levied a penalty against Baxter "for engaging in improper intra-company foreign exchange transactions" resulting in the net income misstatement. 

By Nick Paul Taylor • Feb. 24, 2022

Yet another survey shows pandemic's persisting toll on healthcare workforce

Over half of the healthcare workers recently surveyed by USA Today and Ipsos Research said they are burned out, and 39% agree with the statement: "The American healthcare system is on the verge of collapse."

By Hailey Mensik • Feb. 23, 2022

Diabetes tech leaders expect another year of growth, innovation as competition soars

MedTech Dive spoke with diabetes technology leaders about what to expect in 2022, the impact of new products and the increasingly competitive market.

By Ricky Zipp • Updated May 12, 2022

FDA publishes proposed rule to align quality system requirements with international standards

The rule, which harmonizes U.S. good manufacturing practices with ISO standards, could save device companies hundreds of million of dollars by making it easier for those that comply with both standards, the agency says.

By Elise Reuter • Feb. 22, 2022

Baxter infusion pump recall labeled Class I by FDA

The recall labeling on Friday follows a safety notification issued by the agency in February, which warned that "use of the affected products may cause serious adverse events."

By Elise Reuter • Updated March 14, 2022

Quidel expects COVID-19 test demand to continue through Q2, but offers no 2022 guidance

CEO Doug Bryant told investors Thursday that Quidel is seeing testing demand moderate in February, but the first quarter will result in the largest revenue in the company's history. The company did not provide full-year guidance.

By Greg Slabodkin • Feb. 18, 2022

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

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