FDA prioritizes guidance on lab developed tests in 2025 plan

The Center for Devices and Radiological Health intends to develop final guidance on its enforcement discretion policy regarding special controls for LDTs, among other topics.

By Nick Paul Taylor • Oct. 18, 2024

Legacy medical devices keep regulators up at night

The FDA’s Suzanne Schwartz said at The Medtech Conference that addressing legacy devices is a “work in progress” and a problem regulators and industry need to work on together.

By Elise Reuter • Oct. 17, 2024

4 steps to minimize the threat of legacy medical devices

Older medical devices with unsupported software pose cybersecurity threats that regulators and industry are struggling to solve. Here are four steps experts say can help mitigate risks.

By Ricky Zipp • Sept. 23, 2024

Henry Schein’s slow recovery from cyber incident hits Q2 results

William Blair analysts said the “lingering impacts from the cyberattack are somewhat surprising.”

By Nick Paul Taylor • Aug. 7, 2024

FDA officials outline benefits of AI lifecycle management

The digital health leaders detailed a seven-stage diagram for how the healthcare industry could monitor artificial intelligence software development.

By Nick Paul Taylor • July 30, 2024

CrowdStrike outage hits US hospitals

The cybersecurity firm released what was meant to be a routine software update, but now health systems, including CommonSpirit Health and Cleveland Clinic, are locked out of Windows systems.

By Susanna Vogel • July 19, 2024

CISA warns of cybersecurity risks in Baxter products

The cybersecurity notices covered vulnerabilities identified in a Baxter Welch Allyn patient monitor and a Baxter Welch Allyn configuration tool.

By Ricky Zipp • Updated June 10, 2024

More than a third of healthcare organizations aren’t prepared for cyberattacks: report

Thirty-seven percent of healthcare organizations did not have a cyberattack contingency plan in place, despite half having experienced an attack, according to a new survey from Software Advice.

By Sydney Halleman • May 28, 2024

GE Healthcare warns of cybersecurity risks in ultrasound devices, software

Cybersecurity group Nozomi Networks Labs identified 11 vulnerabilities across several systems and software in an investigation of imaging machines.

By Nick Paul Taylor • May 15, 2024

Livanova says patient data obtained in 2023 cyberattack

Livanova learned that an unauthorized party obtained patient data, including Social Security numbers and health conditions, during last year’s attack.

By Ricky Zipp • April 26, 2024

Files taken from Orasure systems in cybersecurity incident

Orasure believes it has contained the incident and “preserved the integrity of its core financial and operational systems.”

By Nick Paul Taylor • April 17, 2024

As cyberattacks on healthcare persist, can the FDA’s new device regs hold up?

Revamped regulations to thwart hackers are a big step forward, but issues such as legacy devices and reliance on software patches pose lingering challenges.

By Ricky Zipp • April 3, 2024

FDA seeks feedback on expansion of premarket cybersecurity guidance

The agency is providing information on cybersecurity requirements for companies seeking authorization of new devices. 

By Nick Paul Taylor • March 13, 2024

AI to expand medtech portfolios, revenue streams: Moody’s

The rating agency predicts AI will start to have a positive impact on medical device companies in the next two years.

By Nick Paul Taylor • March 12, 2024

Henry Schein expects cyber incident costs to continue in 2024

The company reported a $350 million to $400 million reduction in Q4 sales due to the incident, which forced it to take some systems offline. 

By Elise Reuter • Feb. 27, 2024

FDA creates ‘super office’ to oversee device cybersecurity, digital health and supply chain

The reorganization establishes new divisions at the Office of Strategic Partnerships and Technology Innovation to account for its growth since 2019.

By Nick Paul Taylor • Jan. 25, 2024

Patient records exposed in data breaches doubled in 2023

Though the number of data breaches declined slightly from 2022, more than 116 million records were exposed last year, according to a new report from a cybersecurity firm.

By Emily Olsen • Jan. 22, 2024

Roundup: Cyber incidents, vulnerabilities hit the medtech sector in 2023

From vulnerable medical devices to a breach that took some of Henry Schein’s systems offline, cybersecurity was a key topic for the industry this year.

By Ricky Zipp • Dec. 21, 2023

White House wants to set minimum cyber standards for hospitals, healthcare

The sector has faced a wave of ransomware linked to the critical CitrixBleed vulnerability, which has led to major attacks from LockBit and other threat groups.

By David Jones • Dec. 12, 2023

Henry Schein says 29K people affected in September cyber incident

The ransomware group AlphV/BlackCat has claimed responsibility for the data breach and a second incident involving the company.

By Susan Kelly • Dec. 8, 2023

LivaNova warns cybersecurity incident disrupts systems, takes steps to limit impact

The medical device maker warned that the incident is expected to continue to disrupt its business operations.

By Nick Paul Taylor • Nov. 27, 2023

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

Henry Schein says customer data breached in cyber incident

The company lowered its 2023 sales and earnings forecasts in response to the incident, which took some of its distribution systems offline.

By Elise Reuter • Nov. 13, 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

Cybersecurity incident prompts Henry Schein to take systems offline, disrupting operations

The incident affected a portion of the company’s manufacturing and distribution businesses.

By Nick Paul Taylor • Oct. 18, 2023