LetsGetChecked secures first FDA authorization for at-home chlamydia and gonorrhea test

Jeff Shuren, director of the Center for Devices and Radiological Health, said the test will give patients “more information about their health from the privacy of their own home.”

By Nick Paul Taylor • Nov. 16, 2023

Congress delays Medicare lab payment cuts for one year

The American Clinical Laboratory Association said it remains focused on getting legislation passed that would mitigate pending Medicare payment reductions.

By Susan Kelly • Nov. 16, 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-ordered report tackles how to manage cybersecurity risks of legacy devices

The report from MITRE proposes multiple actions for protecting older medical devices, including research into more modular devices and collecting data on cyber risks.

By Nick Paul Taylor • Nov. 16, 2023

Cardinal’s changes to disposable syringes trigger FDA Class I recall notice

The problem is linked to 15 reports of delayed therapy and 13 reports of inaccurate dispensing.

By Nick Paul Taylor • Nov. 15, 2023

Biden initiative aims to accelerate women’s health research

AdvaMed endorsed the White House effort, stressing the need for equitable development and funding of new technologies.

By Susan Kelly • Nov. 14, 2023

Olympus receives Class I recall label for another bronchoscope safety issue

The company's latest corrective action follows four reports of “endobronchial combustion” during procedures with its bronchoscopes.

By Ricky Zipp • Updated Dec. 21, 2023

FDA warns providers about using surgical mesh for breast surgery after BD label update

The regulator reminded providers that there are “no surgical mesh products cleared or approved by the FDA for use in breast surgery.”

By Nick Paul Taylor • Nov. 13, 2023

Acon receives first FDA clearance for over-the-counter COVID-19 antigen test

The FDA is encouraging manufacturers to transition to traditional review pathways now that the acute phase of the COVID-19 crisis is over.

By Nick Paul Taylor • Nov. 10, 2023

NICE backs use of hybrid closed loop systems for Type 1 diabetes, if companies offer discounts

The group’s recommendation gives around 150,000 people with Type 1 diabetes living in England the chance to access the systems, according to an NHS England official.

By Nick Paul Taylor • Nov. 9, 2023

FTC challenges patents held by nine big drugmakers, citing unfair competition

The agency claims intellectual property for emergency allergy shot EpiPen and asthma medication Advair was “improperly listed” in an FDA database.

By Jonathan Gardner • Nov. 8, 2023

25 attorneys general urge FDA to act fast to mitigate risk of racial bias in pulse oximetry

The AGs want the FDA to “require manufacturers and vendors of pulse oximeters to include clear, comprehensible and evidence-based warning labels.”

By Nick Paul Taylor • Nov. 7, 2023

FDA extends pandemic-era policy allowing certain device, production changes without prior approval

Companies can make limited modifications on certain devices and manufacturing processes to address supply shortages or production limitations.

By Ricky Zipp • Nov. 2, 2023

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

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