FDA finalizes guidance on how clinical decision support software is regulated

The FDA has overhauled the 2019 draft, deleting some sections and completely rewriting other parts of the document.

By Nick Paul Taylor • Sept. 28, 2022

FDA switches COVID-19 tests to De Novo, 510(k) pathways, limiting EUAs

The FDA will still review EUA requests from “experienced developers” of tests that meet certain criteria.

By Nick Paul Taylor • Sept. 28, 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

FDA user fees package won’t include any amendments, House leaders say

Cybersecurity and clinical trial diversity amendments passed by the U.S. House of Representatives won’t be in the final version of the bill.

By Elise Reuter • Sept. 27, 2022

FDA makes case for ‘new regulatory paradigm’ amid hurdles in software-oversight program

The agency seeks to tailor requirements based on the latest science, the benefits and risks posed by devices, their real-world performance and their contribution to promoting health equity.

By Nick Paul Taylor • Sept. 27, 2022

Puerto Rico-based lab ceases COVID-19 test; FDA revokes EUA

The FDA disclosed the action alongside updates to the instructions for use for Thermo Fisher Scientific’s TaqPath COVID-19 test.

By Nick Paul Taylor • Sept. 26, 2022

Philips’ latest BiPAP machine recall labeled Class I event by FDA

Certain bi-level positive airway pressure devices feature plastic that could cause machines to stop working suddenly, potentially leading to serious injury or death, the FDA said Friday.

By Nick Paul Taylor • Sept. 26, 2022

Device makers with ethylene oxide facilities at risk of lawsuits after Sterigenics loss: Needham

The $363 million award in the Sterigenics lawsuit “could lead to increased aggressiveness on the part of attorneys,” Needham analysts warned in a Friday note to investors.

By Ricky Zipp • Sept. 23, 2022

FDA user fee package to be included in Congress’ bill to fund government, avoid shutdown, Senators say

A “practically clean” version of the bill will allow the FDA to continue its review and testing programs, while leaving more ambitious goals to a funding bill later this year. 

By Elise Reuter • Sept. 22, 2022

As deadline for FDA user fees bill nears, Congress weighs continuing resolution

Reauthorization bill is likely to pass before Sept. 30, but it’s unclear what provisions will be included in the final version, experts said.

By Elise Reuter • Updated Sept. 22, 2022

Medtronic gets first FDA approval for drug-eluting stent in bifurcation lesions

Researchers have found the one-device, provisional stenting method delivers better results than two stents in some patients.

By Nick Paul Taylor • Sept. 22, 2022

Watchdog faults FDA for rushing COVID-19 tests to market by easing emergency use rules

HHS’ Office of Inspector General found that by loosening emergency use authorization requirements to bring COVID-19 tests to market faster, the agency allowed inaccurate tests to be distributed.

By Elise Reuter • Sept. 21, 2022

Insulet’s Omnipod 5 gains CE Mark for European release

After months of regulatory delays, Insulet’s newest insulin pump can now be marketed in the U.S. and European Union.

By Nick Paul Taylor • Sept. 21, 2022

Jury decides against Sterigenics in ethylene oxide trial, awarding $363M to the sole plaintiff

Sterigenics has more than 760 lawsuits pending against it in the local court for toxic emissions previously emitted by the plant.

By Nick Paul Taylor • Sept. 20, 2022

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

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