Policy & Regulation: Page 2

FDA updates advice about Medtronic endotracheal tubes after Class I recall, patient death reports

The FDA provided more detailed recommendations on preventing and responding to airway obstruction that may occur when using some Medtronic endotracheal tubes.

By Peter Green • Sept. 19, 2022

Racial bias in pulse oximeters to be subject of FDA panel

The design of the ubiquitous fingertip monitors has inadvertently caused false blood oxygen readings in darker-skinned patients, a problem the FDA hopes to fix.

By Peter Green • Sept. 16, 2022

Explore the Trendline➔

Medical device industry continues to turn to digital health, AI

While the industry continues to embrace digital health and artificial intelligence, there are still questions about how the new technologies and services need to be regulated and if they are effective.

By MedTech Dive staff

Baxter’s recall of solution sets used in chemotherapy labeled Class I by FDA amid complaints of leaks

The regulator says the leaks could kill, but with 83 complaints it has not received reports of patient injuries or deaths.

By Ricky Zipp • Sept. 15, 2022

Tasso’s at-home blood collection lancet wins FDA clearance

Tasso is pitching the device as an enabler of decentralized clinical trials because it could simplify the collection of blood at home.

By Nick Paul Taylor • Sept. 15, 2022

Edwards updates Sapien TAVR device for greater durability

The device uses Edwards’ Resilia tissue technology to enable dry storage and potentially extend device durability.

By Nick Paul Taylor • Sept. 14, 2022

Investor lawsuit accuses Medtronic of failing to disclose insulin pump problems

The plaintiffs claim Medtronic failed to disclose that its product quality control systems were inadequate and that it was noncompliant with regulations.

By Nick Paul Taylor • Sept. 13, 2022

J&J agrees to settle class action pelvic mesh suits in Australia for more than $200M

Shine Lawyers, the firm representing the patients, said that the Federal Court of Australia still needs to approve the terms of the agreement.

By Ricky Zipp • Sept. 13, 2022

Philips says French prosecutors investigating respirator recall

While the company confirmed it faces lawsuits in France, Philips said it’s too early “to speculate about any potential exposure.”

By Elise Reuter • Sept. 9, 2022

FDA alerts physicians to lock malfunction with Abbott’s MitraClip heart valve device

The problem, which the FDA said occurs in 1.3% of procedures, can have consequences including the need for surgery to treat significant residual disease. 

By Nick Paul Taylor • Sept. 9, 2022

FDA: Reports of squamous cell carcinoma, lymphomas in scar tissue around breast implants

The report adds to the history of product safety problems for breast implant devices, including patient injuries and deaths.

By Ricky Zipp • Sept. 8, 2022

French prosecutors investigating Philips Respironics recall: Reuters

In addition to a U.S. DOJ inquiry, Philips now faces an investigation from French prosecutors over its recall of sleep apnea machines and ventilators. 

By Elise Reuter • Sept. 8, 2022

FDA issues first EUA for monkeypox test

Quest Diagnostics' PCR test for monkeypox received emergency use authorization after the FDA issued guidance on how it will evaluate the tests.

By Elise Reuter • Sept. 8, 2022

HHS will allow EUAs for monkeypox tests to increase access in the US

The move follows the declaration of a public health emergency for the monkeypox outbreak on Aug. 4.

By Ricky Zipp • Sept. 7, 2022

FDA clears Magnus neuromodulation system in major depressive disorder

Almost 80% of people treated with the SAINT system entered remission, compared to 13% of their peers in the control group.

By Nick Paul Taylor • Sept. 7, 2022

Philips recalls 17M sleep apnea masks over magnets that could affect implanted devices

The problem has caused 14 serious injuries, and the FDA cautioned that the issue could lead to deaths.

By Nick Paul Taylor • Updated Sept. 8, 2022

Illumina’s hold on Grail depends now on separate appeals in U.S., Europe

Even as it plans to appeal a European Commission decision and the FTC plans to appeal a U.S. ruling, Illumina say it’s preparing for ‘strategic alternatives’ to its acquisition of early cancer detection firm Grail.

By Elise Reuter • Updated Sept. 7, 2022

European Commission blocks Illumina-Grail deal to ‘preserve competition’ in cancer test market

The EC decision comes after a U.S. ruling to let the acquisition move forward and leaves Illumina facing an uncertain future in a competitive market for next-generation gene tests to detect cancer.

By Ricky Zipp • Sept. 6, 2022

Federal jury convicts medtech executive in $77M blood testing kickback case

Arrayit President Mark Schena’s conviction on nine federal charges carries a maximum sentence of more than 100 years in prison.

By Nick Paul Taylor • Sept. 6, 2022

CDC backs updated COVID shots from Pfizer, Moderna

One day after the FDA’s authorization, the CDC recommended the companies’ omicron-targeted vaccines for most adults and children over 12 years old.

By Delilah Alvarado • Sept. 2, 2022

Vibrating, colon-stimulating capsule to treat chronic constipation approved by FDA

Vibrant Gastro’s drug-free capsule increased complete spontaneous bowel movements in a pivotal clinical trial, opening a new treatment pathway for the millions of Americans suffering from severe constipation.

By Nick Paul Taylor • Sept. 2, 2022

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

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