Philips pays $24M to settle second set of claims by US Justice Dept.

Respironics allegedly purchased, “at a significant cost to itself,” data on the prescribing decisions of U.S. physicians and gave the information to durable medical equipment suppliers so that they would promote its products.

By Nick Paul Taylor • Sept. 2, 2022

Judge rules in favor of Illumina-Grail merger, countering FTC concerns

A ruling by a federal administrative judge makes it more likely Illumina can keep control of its one time subsidiary, which makes cancer tests. A European Union anti-competition review is still pending. 

By Ricky Zipp , Elise Reuter • Updated Sept. 2, 2022

Explore the Trendline➔

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

Baxter gets 510(k) clearance for syringe pump, spurring optimism of faster FDA review process

Syringe pumps are a potential new driver of growth for Baxter, and analysts at J.P. Morgan called the clearance “a nice win for the company,” as FDA timelines for pumps more broadly have remained “a challenge” for medtech companies. 

By Nick Paul Taylor • Sept. 1, 2022

Malfunctioning Integra intracranial monitor was used on patient who died: FDA

The team caring for the patient had to replace the sensor in a malfunctioning monitor, but Integra determined that the death was unrelated to the device, the agency said. 

By Nick Paul Taylor • Sept. 1, 2022

Recall Watch: Hamilton ventilator, Intera pump recalls get Class I label from FDA

The FDA assigned the recalls to its most serious risk category in light of the potential for serious injuries and deaths.

By Nick Paul Taylor • Aug. 30, 2022

Philips recalls some BiPAP machines because of contaminated plastic

The FDA said the latest action is not associated with the company’s sleep apnea machine recall, although some devices are affected by both.

By Ricky Zipp • Aug. 29, 2022

FDA takes N95 respirators off medical device shortage list

Respirators were one of the first medical devices identified as being in critical shortage during the COVID-19 public health emergency, the agency said.

By Ricky Zipp • Aug. 29, 2022

Medtronic gets CE mark for drug-eluting stent and kicks off European launch

Medtronic calculated that changes to the stent resulted in a 16% improvement in drug deliverability.

By Nick Paul Taylor • Aug. 25, 2022

Abbott wins FDA approval for spinal cord stimulation treatment of multi-site pain

The approval gives Abbott a new angle as it seeks to win market share from Boston Scientific, Medtronic and Nevro.

By Nick Paul Taylor • Aug. 24, 2022

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

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