Medtech industry condemns Russia's invasion of Ukraine

While companies offered their support for Ukraine and those impacted by the crisis, Siemens Healthineers offered the strongest statement, calling Russia's invasion a "clear violation of international law."

By Ricky Zipp , Greg Slabodkin • March 7, 2022

Panel warns against 'knee-jerk' rejection of globalization, calls for medical supply chain transparency

Instead of onshoring device manufacturing to stabilize supply chains, a congressionally-mandated committee has recommended more transparency, including disclosing manufacturing sites for all products and components.  

By Nick Paul Taylor • March 7, 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

FDA final guidance presses industry to be 'recall ready'

AdvaMed said the biggest concern with the earlier guidance was the potential for conflicting interpretations of whether an older regulation still applies to the initiation of recalls. The FDA has clarified the issue in the finalized guidance. 

By Nick Paul Taylor • March 4, 2022

Healthcare job gains in February far exceed recent months

Healthcare added 64,000 jobs last month, though employment in the sector is still down by about 306,000 jobs, or 1.9%, since February 2020.

By Hailey Mensik • March 4, 2022

Industry supports FDA's proposed quality system regulations, but says more time needed to adjust

"I think the potential benefit is likely to be realized very far downstream," Robert Phillips, vice president of quality and regulatory for Siemens Healthineers, said at the FDA's Wednesday meeting on QSR.

By Elise Reuter • March 3, 2022

Biden discusses drug prices, mental health services in annual address

The president also announced a "test to treat" program that would allow people to receive a COVID-19 test at a pharmacy and immediately receive free antiviral pills, such as Pfizer's Paxlovid or Merck's molnupiravir.

By Shannon Muchmore • March 2, 2022

Celltrion recalls 1.2M rapid COVID-19 tests for improper labeling

The company initiated the fourth recall of its rapid COVID-19 tests in recent weeks, which the FDA designated as a Class II recall.

By Nick Paul Taylor • Updated March 9, 2022

'We have to make a stand': Biotech leaders vow to break ties with Russia over Ukraine war

Biotech CEOs Paul Hastings and Jeremy Levin explained the goals behind a letter supported by more than 400 executives and investors that calls for drugmakers to stop working with Russian companies.

By Ben Fidler , Ned Pagliarulo • Updated March 1, 2022

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

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