Getinge’s recall of 11,000 ventilators labeled Class I event by FDA

The company is fixing a software bug that can inadvertently stop the ventilator from working.

By Nick Paul Taylor • Aug. 24, 2022

Philips respirator lawsuit builds as plaintiffs’ attorneys outline lengthy recall delays

New filings in a class action lawsuit allege that Philips waited years to disclose the risk of foam used in its sleep apnea machines and respirators, causing illness and injuries.

By Elise Reuter , Peter Green • Updated Aug. 23, 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

Lab group ACLA warns ‘inadequate’ payment rates may limit access to monkeypox testing

The trade group urged the CMS to ensure monkeypox testing claims are paid at its “reasonably derived” recommended rate to ensure access to testing.

By Nick Paul Taylor • Aug. 23, 2022

Insulet’s Omnipod 5 insulin delivery system approved for preschool children

Adding preschoolers will broaden the market for the Omnipod after the launch of the device for people aged six years and older helped Insulet boost U.S. sales by 31% in the second quarter.

By Nick Paul Taylor • Aug. 23, 2022

Medtronic gets third Class I label in 2022 for latest HVAD recall

The latest recall is for nearly 40,000 batteries for the HeartWare Ventricular Assist Device system.

By Ricky Zipp • Aug. 19, 2022

Eargo plans to sell its hearing aids in stores after over-the-counter ruling

Best Buy, which announced it would sell over-the-counter hearing aids in more than 300 stores, has listed the Eargo 6 as one of the products it will offer.

By Elise Reuter • Aug. 18, 2022

Visibly wins FDA clearance for self-administered online vision test

The agency has placed restrictions on the test, limiting it to adults aged 22 to 40 years and cautioning that it only gives “supportive recommendations.”

By Nick Paul Taylor • Aug. 17, 2022

FDA reviews rise in Philips respiratory device reports, including 44 deaths

The agency received more than twice as many reports linked to foam breakdown from May to July than from April 2021 to April 2022.

By Nick Paul Taylor • Aug. 17, 2022

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

‘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