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

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

FDA finalizes guidance on cybersecurity for medical devices

Congress granted the agency authority to deny premarket submissions that lack cybersecurity information, starting in October. 

By Nick Paul Taylor • Sept. 27, 2023

FDA proposes 3 guidances to improve 510(k) clearance process

The agency has made recommendations for selecting predicate devices, using clinical data and conducting performance testing for implants.

By Nick Paul Taylor • Sept. 7, 2023

Becton Dickinson flags cybersecurity vulnerabilities in Alaris system

The company identified eight security issues affecting its infusion pump system, including one high-risk concern.

By Elise Reuter • July 13, 2023

Medtronic identifies cybersecurity vulnerability in cardiac data system

Cyber attackers could exploit the vulnerability if healthcare organizations have enabled its optional messaging service, the device maker said.

By Susan Kelly • July 5, 2023

The importance of trust in AI as a medical device

Building trust with patients, as well as regulators, will be key to the adoption of AI in medical devices and diagnostics, argues Alison Dennis, a London-based partner with law firm Taylor Wessing.

By Alison Dennis • June 15, 2023

MedTech Europe sets out position on cybersecurity, making case for reliance on MDR

As the number of connected medical devices grows, the industry group argues that Europe’s new medtech regulations should remain “the primary avenue” for medical device cybersecurity.

By Nick Paul Taylor • Updated June 12, 2023

FTC moves to strengthen Health Breach Notification Rule’s applicability to digital health apps

Regulators are increasingly leaning on the HBNR to crack down on the sharing of sensitive medical data, and the FTC is looking to strengthen its case.

By Rebecca Pifer • May 18, 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

FDA says it won’t issue ‘refuse to accept’ letters on cyber devices before Oct. 1

Until October 1, the FDA will work with device makers to ensure pre-market submissions have adequate cybersecurity information.

By Elise Reuter • Updated March 30, 2023

Friday Q&A: MedCrypt’s Naomi Schwartz on designing cybersecurity for diabetes devices

Schwartz, who helped review the first automated insulin dosing system, talks about balancing patient access and device security.

By Elise Reuter • March 3, 2023

Why medical device designers need to become more agile — and how they can do it

To stay competitive, medtech firms must center manufacturing in business optimization plans, while embracing a design-to-value approach, says Jennifer Samproni, Flex’s chief technology officer for its Health Solutions division.

By Jennifer Samproni • Jan. 26, 2023

Medtech regulation outlook in 2023: Faster approvals among priorities as AI moves to fore

Leaders in the medtech field weigh in on the prospects and challenges for product regulation in 2023.

By Peter Green • Updated Jan. 26, 2023

Cybersecurity ‘more critical than ever’ in era of connected care: BD

The device maker’s annual report on the state of healthcare cybersecurity calls for better transparency and coordination across the industry.

By Susan Kelly • Jan. 25, 2023

FDA outlines benefits and risks of emerging augmented and virtual reality medical devices

AR/VR may increase access to healthcare and make procedures less invasive, but could potentially cause cybersickness and head and neck strain.

By Nick Paul Taylor • Dec. 8, 2022

Vulnerability in BD’s infusion pump flagged to US cybersecurity agency

An attacker with physical access to the device could exploit the vulnerability to change the configuration settings or disable the pump.

By Nick Paul Taylor • Updated Dec. 6, 2022

The 10 biggest medtech stories of 2022

MedTech Dive reporting this year has explored how companies maintained momentum even amid supply shortages and rising inflation rates.

By MedTech Dive staff • Dec. 3, 2022

HHS cybersecurity center warns of new ransomware threat

Venus ransomware has attacked targets worldwide, including at least one U.S. health group, since it was first identified in mid-August.

By Susan Kelly • Nov. 14, 2022