FDA’s breakthrough device designations poised for another record year

At the midpoint of the year, the FDA had granted 129 designations, suggesting it will break the previous full-year record of 206.

By Nick Paul Taylor • Aug. 8, 2022

SEC accuses surgical implant business of pulling forward sales to hit targets

According to the SEC, Surgalign, known at the time as RTI Surgical, shipped future orders ahead of schedule to pull forward revenues and mask disappointing sales figures.

By Nick Paul Taylor • Aug. 5, 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

Biden administration declares monkeypox a public health emergency

Federal health officials said Thursday that U.S. monkeypox testing capacity is at about 80,000 tests per week, although only 10% of capacity is currently being used.

By Ricky Zipp • Aug. 4, 2022

Hospitals have low level of accountability for connected device breaches

Of the 43% of organizations that reported a data breach in the past two years, 88% said at least one connected device was a contributing factor to the breach, according to a new report.

By Rebecca Pifer • Aug. 4, 2022

EPA names BD, Edwards and Medtronic on list of higher-risk sterilization facilities

AdvaMed said ethylene oxide is vital for prevention of serious infections and shutting facilities could disrupt the supply of medical devices.

By Nick Paul Taylor • Updated Aug. 5, 2022

6 questions for the medtech industry if Congress doesn’t reauthorize FDA user fees on time

If Congress doesn’t pass the legislation before Sept. 30, furloughs and delays lie ahead for the agency.

By Elise Reuter • Aug. 3, 2022

Siemens Healthineers stumbles as lockdowns, falling COVID-19 sales and rising costs hit business

Lockdowns in China caused a steep decline in equipment orders and a big setback to the firm’s core diagnostic business, even as the company expects to meet full year revenue targets.

By Nick Paul Taylor • Aug. 3, 2022

DOJ sues Idaho over near-total abortion ban in first post-Roe challenge

In a suit filed in Idaho’s southern district, the Department of Justice claimed that Idaho’s “near-absolute” abortion ban blocks clinicians from providing necessary care in medical emergencies as required by federal law. 

By Sydney Halleman • Aug. 2, 2022

North American Diagnostics latest to recall COVID-19 tests, gets Class I label from FDA

The recall adds to a list of medtech firms that have been forced to withdraw illegally distributed COVID-19 tests, amid concerns they could yield false results.

By Ricky Zipp • Aug. 2, 2022

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

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