Boston Scientific gets DOJ subpoena for documents related to heart monitoring

The disclosure comes as cardiac monitoring device maker iRhythm also said it received a request from the Justice Department.

By Susan Kelly • May 5, 2023

CDC Director Walensky to step down in June

Rachel Walensky, who has served as director since 2001, was criticized for the federal government’s handing of the pandemic, announcing in August last year that she planned to reorganize the CDC.

By Sydney Halleman • May 5, 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FDA posts draft guidance on studying medical devices in decentralized clinical trials

Analysts at Cowen said the draft could reassure sponsors they can run decentralized trials without complicating approvals.

By Nick Paul Taylor • May 4, 2023

Great Britain proposes allowing CE marks until 2030 to minimize Brexit disruption

The extended timeline to create a new regulatory system in England, Scotland and Wales is intended to prevent medical device shortages.

By Nick Paul Taylor • May 1, 2023

Illumina gets cybersecurity warning from FDA over sequencing software

The vulnerability could result in an attacker gaining control of an instrument remotely and altering genomic data results, the agency said.

By Susan Kelly • Updated April 28, 2023

Medtronic diabetes warning letter lifted by FDA

The resolution will allow Medtronic to bring new products to market faster, such as its new continuous glucose monitor, Simplera.

By Elise Reuter • April 25, 2023

Medtronic wins FDA approval for long-delayed MiniMed 780G insulin pump

Analysts called the FDA approval a “positive” for Medtronic that “should somewhat aid in a turnaround of its U.S. diabetes franchise.”

By Nick Paul Taylor • April 24, 2023

Supreme Court maintains access to abortion pill, blocking restrictions on its use

The decisions stayed by the Supreme Court could affect future challenges to the FDA’s authority to regulate drugs and medical devices.

By Delilah Alvarado • Updated April 22, 2023

Report names connected medical devices with the biggest cybersecurity risks

The findings come as medical device makers face upcoming FDA requirements for providing cybersecurity information as part of their pre-market submissions.

By Nick Paul Taylor • April 21, 2023

Ending free COVID tests risks worsening the pandemic

If Americans start paying out of pocket for COVID tests, they'll test much less — if at all, argue representatives of the Testing at Home Coalition.

By Amy Kelbick and Eric Zimmerman • April 20, 2023

Abbott hit with FDA warning letter over unapproved changes to heart disease test

The FDA said that four changes made to the tests “could significantly affect the safety or effectiveness of the devices.”

By Nick Paul Taylor • Updated April 20, 2023

Fresenius flags fault with infusion system acquired last year in $240M deal

Fresenius noted a problem with the devices that can cause loss of power, potentially delaying or interrupting the supply of critical fluids and medications. 

By Nick Paul Taylor • April 20, 2023

Post-approval modification of high-risk devices linked to 30% jump in recall risk: study

The authors suggest improved post-marketing surveillance systems may be needed to mitigate risks to patient safety.

By Nick Paul Taylor • April 18, 2023

Zimmer’s ‘smart knee’ implant may qualify for new technology payments from CMS

If finalized, the add-on payments would help cover the cost of the sensor technology included in the company’s Persona IQ knee implants.

By Elise Reuter • April 12, 2023

Illumina-Icahn proxy battle heats up as Grail divestment orders loom

DNA-sequencing provider Illumina is headed for a showdown with billionaire financier Carl Icahn over three of nine seats on its board of directors as it continues to defy regulators’ orders to divest cancer test maker Grail.

By Susan Kelly • April 12, 2023

FDA starts device sterilization pilot program to help industry adapt to EtO emission clampdown

The FDA “recognizes the need to facilitate more timely changes” amid a push to cut EtO emissions and constraints on the supply of radioactive cobalt.

By Nick Paul Taylor • April 12, 2023

Icahn pushes for spinoff of Illumina’s Grail liquid biopsy unit

The billionaire financier, who is waging a proxy fight for seats on Illumina’s board, is arguing that Grail should become a standalone publicly traded company.

By Susan Kelly • April 11, 2023

Medical device groups say ‘the stakes are high’ with new EtO regulations

AdvaMed, which represents medical device companies, warned that patients could face treatment delays if sterilization facilities close.

By Elise Reuter • April 11, 2023

EPA to limit ethylene oxide emissions from medical device sterilizers

The agency proposed new emissions limits that device sterilization companies would have 18 months to meet.

By Elise Reuter • April 11, 2023

Illumina backs its board in proxy fight with Icahn

Illumina directors up for re-election to one-year terms include prominent leaders in healthcare such as former FDA Commissioner Scott Gottlieb and longtime Intuitive Surgical CEO Gary Guthart.

By Susan Kelly • April 10, 2023

Philips recalls 1,200 reworked sleep apnea devices over fault that can cause therapy failure

The problems keep mounting for Philips, as recently repaired respirators now need to be fixed in a recall the FDA has labeled a Class I event.

By Nick Paul Taylor • April 10, 2023

EPA proposes stricter ethylene oxide pollutant rules for chemical makers

Further EPA proposals involving medical device sterilization plants are expected to be forthcoming.

By Susan Kelly • April 7, 2023

Diagnostic testing reform bill has a path to the finish line this year: AdvaMed

Legislators recently reintroduced the VALID Act, which would bring lab-developed tests and in-vitro diagnostics under one framework, after failing to pass the bill twice last year.

By Elise Reuter • Updated April 5, 2023

Why won’t Illumina sell Grail?

While financier Carl Icahn and regulators in the U.S. and Europe want DNA-sequencing company Illumina to divest liquid biopsy company Grail, Illumina’s board won’t budge. Analysts say they may be waiting for the best moment.

By Susan Kelly • April 4, 2023

Masimo receives De Novo nod from FDA for device designed to detect signs of opioid overdose

The system detects patterns associated with opioid-induced respiratory depression and sends alerts that escalate in line with the risk level.

By Nick Paul Taylor • April 4, 2023