White House orders HHS to start collecting reports on the safety of AI in healthcare

President Joe Biden outlined the planned program as part of an executive order on “safe, secure, and trustworthy” artificial intelligence.

By Nick Paul Taylor • Nov. 1, 2023

FDA holds firm on 60-day comment period for lab-developed test rule

The agency is proposing to expand its oversight of tests made by laboratories because it says risks associated with the diagnostics have increased.

By Susan Kelly • Nov. 1, 2023

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

FDA warning letter accuses Wavi of selling unapproved neurological device

Wavi markets its headset as providing a baseline scan for patients who have a traumatic event, an injury or are worried about their brain as they age.

By Nick Paul Taylor • Nov. 1, 2023

Tracking Philips Respironics recalls

Philips recalled its Trilogy ventilators to fix new and previously reported problems with the machines. The company issued a mandatory software update and changed the devices’ instructions.

By Elise Reuter • Updated Oct. 3, 2024

FDA posts updated safety data on Bayer’s Essure, notes progress on improving study

The agency removed the “inadequate” progress tag it applied last year after Bayer acted to get people back in the study.

By Nick Paul Taylor • Oct. 31, 2023

Philips leader signed off on sale of respiratory devices despite evidence of health risks: report

Roy Jakobs approved the sale of respiratory devices held by manufacturers after the company stopped shipping new machines, according to an article published last week by Pittsburgh Post-Gazette and ProPublica.

By Nick Paul Taylor • Oct. 30, 2023

Fresenius’ work to replace hemodialysis tubing flagged as Class I recall by FDA

Agency officials warned healthcare professionals last year about the potential for silicone tubing to expose patients to toxic compounds.

By Nick Paul Taylor • Oct. 25, 2023

5 takeaways from the FDA’s updated list of cleared AI/ML medical devices

The agency recently added 171 new devices to its list, with radiology once again accounting for the most authorizations.

By Elise Reuter • Oct. 24, 2023

US trade commission explores impact of patent rules on COVID diagnostics

The USITC report presents conflicting testimony from the medtech industry and advocacy groups about the impact of compulsory licensing.

By Nick Paul Taylor • Oct. 23, 2023

AdvaMed CEO warns Congress of supply shortages from EtO, PFAS regulations

The trade group leader called for changes to the EPA’s proposals, while a scientist with UCSF said lawmakers should turn to science free of vested financial interests. 

By Elise Reuter • Oct. 20, 2023

Supply disruptions are delaying surgeries and compromising patient care, survey finds

A patient safety nonprofit used the findings to call for “long-term, nationally coordinated solutions” to stop persistent shortages.

By Nick Paul Taylor • Oct. 19, 2023

FDA finalizes COVID-era guidance, extending flexibility for some remote monitoring devices

The agency shortened its list of devices that can continue to undergo limited modifications without 510(k) filings.

By Nick Paul Taylor • Oct. 19, 2023

GE HealthCare cuts formaldehyde levels in neonatal incubators with revised process

The FDA previously alerted healthcare providers to the potential for neonatal incubators to emit airborne chemicals.

By Nick Paul Taylor • Oct. 17, 2023

FDA: ‘We have had a very loud voice’ on EtO

The agency said it is working closely with the Environmental Protection Agency, which is slated to implement a final rule in March limiting ethylene oxide emissions for medical device sterilizers.

By Elise Reuter • Oct. 16, 2023

Masimo wins de novo authorization for measure of high blood oxygen levels

The ORi device is intended to support standard pulse oximetry by providing additional insights into patients with higher than normal oxygenation.

By Nick Paul Taylor • Oct. 16, 2023

J&J receives 510(k) clearance for foot fixation device, targets growing bunion market

The clearance comes shortly after Stryker introduced a minimally invasive system for treating bunions.

By Nick Paul Taylor • Oct. 16, 2023

Illumina details EC timeline, funding requirements for Grail divestment

The European Commission ordered the gene sequencing company to support Grail with two-and-a-half years of funding if it pursues a spinoff.

By Susan Kelly • Oct. 13, 2023

FDA prioritizes guidance on AI, cybersecurity, pulse oximeters in stacked schedule for 2024

The administration is ramping up production of medtech guidance, adding 18 draft documents to the list of priorities for the upcoming financial year.

By Nick Paul Taylor • Oct. 13, 2023

European Commission orders Illumina to divest Grail

The order includes an undisclosed timeline and potential additional fines. Illumina, which has been anticipating the decision, maintains the commission does not have jurisdiction over the completed merger.

By Susan Kelly • Oct. 12, 2023

FDA to establish digital health advisory committee

The agency is seeking advisers to help it understand the benefits, risks and outcomes associated with digital technologies.

By Elise Reuter • Oct. 12, 2023

J&J’s Abiomed hit with FDA warning letter over Impella heart pump

The letter identifies quality system problems in a group of recalled devices and says monitoring software used with the pump requires premarket authorization.

By Susan Kelly • Oct. 12, 2023

Boston Scientific wins diabetic neuropathy approval, joining rivals in growing market

The expanded indication positions Boston Scientific to challenge Abbott, Medtronic and Nevro for the emerging opportunity in spinal cord stimulation to treat the condition.

By Nick Paul Taylor • Oct. 12, 2023

AdvaMed elevates digital health center to division, names board

The new division will focus on four core policy priorities under Chair Taha Kass-Hout, chief technology officer at GE HealthCare.

By Susan Kelly • Oct. 10, 2023

J&J-backed HistoSonics gets de novo clearance for liver cancer treatment

The system offers a minimally invasive alternative to surgical resection and thermal ablation in patients with primary and metastatic liver cancers.

By Nick Paul Taylor • Oct. 10, 2023

EU poised to mandate Illumina sell Grail liquid biopsy unit: FT

Regulators could order the divestment of the business as soon as next week to punish Illumina for defying their authority and “illegally” acquiring Grail.

By Nick Paul Taylor • Oct. 10, 2023