Hearing aids to be available over the counter following final FDA rule

Hearing aids were introduced for over-the-counter purchase in mid-October

By Elise Reuter • Aug. 16, 2022

BD’s recall of emergency vascular access devices labeled Class I event by FDA

The company first announced the recall in June. There have been no reports of serious injuries or deaths tied to the issue.

By Nick Paul Taylor • Aug. 15, 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

‘Underfunded’ FDA falls short in ensuring medical devices protect against cyberattacks, experts say

Medical device manufacturers argue the agency’s current rules on cybersecurity requirements are too restrictive and should be phased in gradually.

By Elise Reuter • Aug. 11, 2022

Medtronic issues Class I recall of implantable cardioverter defibrillators in U.S.

The devices may deliver a reduced shock during high-voltage therapy, about 79% of the programmed energy.

By Nick Paul Taylor • Aug. 11, 2022

Boston Scientific says it’s investigating allegations of anti-bribery law violations

The company says the issue is centered on its operations in Vietnam.

By Nick Paul Taylor • Aug. 10, 2022

Eargo’s Q2 revenue slides amid decline in hearing-aid shipments

The company’s gross system shipments fell by more than 8,000 when compared to the year-earlier period.

By Ricky Zipp • Aug. 9, 2022

FDA’s hearing-aid guidance clears regulatory review amid push by lawmakers for OTC sales

The move comes after the agency proposed the creation of a new category of over-the-counter hearing aids in October.

By Nick Paul Taylor • Aug. 9, 2022

Senate passes $740B bill to lower healthcare costs after months of wrangling

While Republicans successfully challenged a planned $35 insulin price ceiling for patients on private insurance, the law still has implications for makers of diabetes devices.

By Nick Paul Taylor • Aug. 8, 2022

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

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