23 October 2023
FDA clears iPhone app for Insulet’s Omnipod 5 closed loop system
Credit: Farknot Architect via Shutterstock
The US Food and Drug Administration (FDA) has cleared Insulet’s iPhone app for its Omnipod 5 hybrid closed-loop system for patients living with type 1 diabetes.
Already available on Android, Insulet claims the iPhone app clearance means the Omnipod 5 is the only tubeless automated insulin delivery (AID) system with full control from a compatible smartphone.
In addition to functional controls for the system, users will also be able to create customised food data for snacks and meals they consume frequently. The app will be free to users of the Omnipod 5 System.
Insulet stated the iPhone app will first launch with DexCom’s G6 continuous glucose monitoring system. The Omnipod 5 integrates exclusively with Dexcom’s device. A full market release of the app is slated for 2024. The Omnipod 5 was approved by the FDA in January 2022 and received CE marking in September of the same year. It was launched in the UK in June 2023.
10 October 2023
Sidekick Health expands into PDT space with aidhere
Icelandic digital health company Sidekick Health is acquiring German prescription digital therapeutics (PDT) company aidhere in a strategic move that places the business directly into the digital prescription space.
PDTs are an emerging technology area that are expected to exponentially grow in the future as clinicians look for solutions to support chronic disease management. The software-based treatments are highly regulated and delivered on mobile devices that address the behavioral dimensions of several diseases and conditions.
Aidhere’s weight management app Zanadio is one of the top-performing digital health products within Germany’s regulated nationwide DiGA (Digitale Gesundheitsanwendungen) formulary for prescribable digital apps. As a permanently approved DIGA, the app is reimbursed by all statutory health insurers in Germany and has fulfilled more than 50,000 prescriptions.
24 October 2023
Ashley McEvoy exits Johnson & Johnson after 27 years
Johnson & Johnson (J&J) executive vice-president (EVP) and MedTech worldwide chair Ashley McEvoy will depart after nearly three decades at the company, marking a new era of leadership.
McEvoy joined J&J when she was 26 years old as an assistant product director on Tylenol. Since joining, her career blossomed as she led five businesses in the J&J family.
In an open letter shared on LinkedIn, she expressed her appreciation for the company and the opportunities she had been given. She said: “I’m proud of the way we have transformed the MedTech business into a growth-focused innovator: together over the past five years, we have taken our growth from 1.5% to 8%, deployed more than $22bn in capital in acquisitions, and pushed into new markets, including heart failure, vision, and a robotics business we built from scratch.”
McEvoy will officially depart from J&J in Q1 2024 to help with the role transition.
1 November 2023
Abcam likely to be sold as founder suspends bid to block takeover
Protein research tools supplier Abcam will almost certainly be bought by life sciences and diagnostics provider Danaher, it appears today (1 November) after its founder suspended his bid for shareholders to block the acquisition.
The Abcam-Danaher saga has been one of the more public medical disputes of the year with press releases, LinkedIn posts and interviews coming from both sides to convince shareholders of their position, but it is finally over. Milner announced on his campaign website that he had decided to abandon his efforts after “extensive feedback from the majority of Abcam’s shareholders” that suggests they will vote in favour.
Founder and ex-CEO of Abcam Jonathan Milner began his fight against the takeover in September mere months after suspending his bid to become chairman of the board. He argued and continues to suggest that the deal, which values the UK-based antibody and protein manufacturer at $24 per share, is “subpar”.
1 November 2023
UK MHRA unveils new regulatory sandbox for testing AI
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has announced what it describes as a ‘regulatory sandbox’ where artificial intelligence products are set to be tested.
Dubbed the AI Airlock, the tool is intended to allow developers a safe and isolated set of systems on which AI healthcare tools can be tested and demonstrated, before being implemented in a real-world setting.
The AI Airlock is intended to ensure that medical device manufacturers can understand and deliver what is required to ensure the real-world viability of their products, as well as offering a collaborative approach between different developers.
Paul Campbell, MHRA head of software and AI, said: “Building on the success of the regulatory sandbox, we are excited to deliver a new, world-leading methodology to support safe early access to AI for patients and healthcare.
“We need to ensure that AI is safe and properly regulated, but in a way that doesn’t stifle innovation and access to the latest of medical technologies to improve patient care.”