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

FDA seeks feedback on plans to draft and finalize medical device guidance in 2023

The agency’s review includes guidance on transitioning away from emergency use authorizations, while abandoning plans for guidance on software as a medical device.

By Nick Paul Taylor • Oct. 19, 2022

GE advances healthcare spinoff plan, providing close look at workings of the unit

Localization requirements, third-party servicers, and more sophisticated data security threats are cited as risks to the healthcare unit.

By Nick Paul Taylor • Oct. 13, 2022

BD discloses cybersecurity vulnerability in cervical cytology processing machine

The company is advising users to address the threat by restricting access to the instrument while it works on a software patch.

By Nick Paul Taylor • Oct. 6, 2022

Cyber risks identified in Canon Medical product used to view medical images, security firm says

Vulnerabilities in Canon Medical’s Vitrea View product could provide access to patient information and other services, according to cybersecurity firm Trustwave Spiderlab.

By Ricky Zipp • Updated Sept. 30, 2022

FDA makes case for ‘new regulatory paradigm’ amid hurdles in software-oversight program

The agency seeks to tailor requirements based on the latest science, the benefits and risks posed by devices, their real-world performance and their contribution to promoting health equity.

By Nick Paul Taylor • Sept. 27, 2022

Medtronic issues urgent notice about MiniMed insulin pump system vulnerability

Unauthorized users could hack into the device while it’s being set up, and cause the pump to deliver too much or too little insulin, potentially resulting in outcomes including death.

By Nick Paul Taylor • Sept. 21, 2022

FBI warns of cyber risks from legacy medical devices

Outdated device software can put data, patient safety and hospitals’ operations at risk, the top U.S. law enforcement agency warned.

By Ricky Zipp • Sept. 15, 2022

Cybersecurity firm finds vulnerabilities in Baxter’s Sigma infusion pumps

The weaknesses could allow attackers to access Wi-Fi data and make the device unavailable.

By Nick Paul Taylor • Updated Sept. 8, 2022

‘Underfunded’ FDA falls short in ensuring medical devices protect against cyberattacks, experts say

Medical device manufacturers argue the agency’s current rules on cybersecurity requirements are too restrictive and should be phased in gradually.

By Elise Reuter • Aug. 11, 2022

Friday Q&A: FDA’s former medical device cybersecurity director says more investment needed in staffing

The FDA and medtech companies will need more cybersecurity staff to stay ahead of hackers, says Kevin Fu, who is now focused on building that workforce for the government, private sector and academia.

By Elise Reuter • Aug. 5, 2022

Lack of payment pathway clarity hinders digital therapeutics, analysts say

The report warns of a sector beset by payment issues, “snake oil” and “middling adoption.”

By Nick Paul Taylor • July 15, 2022

DHS warns cybersecurity vulnerabilities in Illumina software could affect test results

Three of the flaws outlined by the Department of Homeland Security received the highest risk score. Vulnerabilities could allow attackers to remotely alter the results generated by Illumina products.

By Nick Paul Taylor • June 6, 2022

BD's Pyxis medication dispenser gets fifth DHS cybersecurity alert in 5 years

The company said there are no known public exploits that specifically target a password vulnerability and that it's working to address the problem.

By Nick Paul Taylor • June 1, 2022

Employees cause more cyber breaches in healthcare than other industries, report finds

Employees were responsible for 39% of healthcare breaches last year. That's compared to 18% across all industries, according to new Verizon research.

By Rebecca Pifer • May 27, 2022

House user-fees bill details clinical trial diversity, cybersecurity requirements

The legislation would let the FDA bring in $1.78 billion in fee revenue from 2023 to 2027 to fund the review of medical devices. That amount could increase to $1.9 billion if the agency meets certain performance goals.

By Elise Reuter • May 10, 2022

CDRH's Shuren expects center to return to normal this year despite ongoing COVID work

Jeff Shuren, the director of the FDA's Center for Devices and Radiological Health, also stressed the need for increased cybersecurity and supply chain funding and authority during an event on April 29.

By Ricky Zipp • May 2, 2022

Medtech survey finds widespread cybersecurity noncompliance despite rising investment

Over 80% of respondents see device security as a competitive advantage and almost every company budgeted more money for it this year. However, 80% view the issue as a "necessary evil" imposed by regulators.

By Nick Paul Taylor • April 21, 2022