MedCrypt in the News

Dexcom Ventures Invests in MedCrypt’s Medical Device Cybersecurity Platform

MedCrypt announces the close of a Series B extension round led by Dexcom Ventures, bringing the company’s total to date to $36.4M. With support from three major investors, MedCrypt continues to lead the way in developing cybersecurity technologies and infrastructure for life-saving medical devices in all facets of healthcare, including the diabetes industry.

FDA Will Begin Rejecting Medical Devices over Cyber Soon

In an announcement on March 29th, the FDA stated that they will soon begin rejecting medical devices that do not meet minimum cybersecurity standards. The new requirements apply to any device that has software or can network with the internet and contains "any such technological characteristics" that could be vulnerable to a cybersecurity threat. Starting Oct. 1st, manufacturers who do not meet cybersecurity standards will face penalties, including the rejection of their products.

FDA to medical device manufacturers: “Get your house in order”

MedCrypt's Mike Kijewski & Naomi Schwartz feature in an article from SC Media about the FDA's recent Refuse to Accept guidelines and what manufacturers can expect from the FDA going forward. While some manufacturers interpret the October 1st deadline of this new guidance as delayed enforcement, kicking the can down the road on implementation could have repercussions down the line.

MedCrypt Funds Security Device Fellowship

MedCrypt announced our funding for a fellowship program at Tufts University’s School of Engineering, aimed at supporting research on medical device security and threat modeling. Led by Ron Thompson and Daniel Votipka, Ph.D., this program aims to conduct research in the Tufts Security & Privacy Lab at the School of Engineering on the effectiveness and practicality of threat modeling and other security measures that organizations can use as a reference to help establish more efficient and repeatable security processes for medical devices.

MedCrypt is Joined by Former FDA Premarket Reviewer and Consumer Safety Officer Naomi Schwartz as New Senior Director of Cybersecurity Quality and Safety

What SBOM details are most important for medical devices? Ken Hoyme, MedCrypt advisory board member, provides insight into effective SBOM use, the importance of threat modeling, and challenges of legacy medical device security in this interview with Marianne McGee from Healthcare Info Security.

MedCrypt lands $25M injection to secure vulnerable medical devices

MedCrypt this week announced that it had raised $25 million in Series B funding, led by Intuitive Ventures and Johnson & Johnson Innovation, to help device manufacturers meet these FDA requirements in order to get critical devices to market faster. MedCrypt works with most of the top medical device manufacturers and says its latest investment — also backed by Section 32, Eniac Ventures, Anzu Partners and Dolby Family Ventures — will help it to bolster both its product and its team to get into the hands of even more.

The FDA’s Medical Device Cybersecurity Overhaul has Real Teeth, Experts Say

Critical Security Considerations for Medical Devices

Too many medical device makers don't pay close attention to the fine details and features of their product designs to ensure they are safe and secure, says Naomi Schwartz, a former product reviewer at the Food and Drug Administration and current cybersecurity adviser at security firm MedCrypt. Listen to the interview to hear more insights from Naomi Schwartz about medical device cybersecurity.

Medical Device SBOMs: Attention to Details Matter

What SBOM details are most important for medical devices? Ken Hoyme, MedCrypt advisory board member, provides insight into effective SBOM use, the importance of threat modeling, and challenges of legacy medical device security in this interview with Marianne McGee from Healthcare Info Security.

What The C-Suite Needs To Know About Security

With concrete goals and expectations for each member of the value chain, there is a clear trend in maturing expectations in both creating and consuming medical device cybersecurity risk. This means leaders face the following question: Is this a matter of managing costs or does this present an opportunity to grow revenue through cybersecurity investment? Discover what the c-suite needs to know about security.

MedCrypt Welcomes Ken Hoyme to Advisory Board

MedCrypt is pleased to announce the addition of Ken Hoyme to our advisory board. In this role, Ken will advise MedCrypt's strategy and support the company on its path of continual growth as a leading provider of medical device cybersecurity solutions. Ken joins as an advisor alongside Michael McNeil, who was added to MedCrypt's Board of Directors in 2020.

Medical Device Manufacturers Need To Act As Regulators Sharpen Their Cybersecurity Guidelines

With the release of premarket and postmarket cybersecurity guidance documents in the past few years, the FDA has provided device manufacturers with practices to adopt in order to make devices secure by design. Security is no longer a nice-to-have, but an imperative. If we only incrementally improve, we will never meet the security needs of our ecosystem.

MedCrypt Wins Cybersecurity Contracts for Three Surgical Robotics Companies

MedCrypt is driving secure innovation with the leading manufacturers of surgical robotics technology. Read how our solutions enable manufacturers to secure various aspects of their systems and interoperable system suites