Device Area

Medtech Insight sat down with Jared Bunch, chair of AF Center of Excellence Task Force, at HRS 2025 to discuss the newly HRS released framework for Afib Center of Excellence and get his perspective on the role industry could play to help clinicians improve patient outcomes.

Former FDA Commissioner Robert Califf urged the Heart Rhythm Society to engage actively amid federal funding cuts. He highlighted collaboration among researchers, advocates for healthcare integration, and the importance of addressing social determinants of health, while discussing lobbying strategies and the challenges faced by medtech companies.

The US FDA continues to issue early alerts as part of its communications pilot aimed at improving how the agency manages recalls. This time, the agency is notifying users about two separate intravascular catheters.

As it celebrates 75 years shaping the medtech industry, Medtronic invited Medtech Insight to its Minneapolis headquarters to get a closer look at the company’s past, what it’s working on now, and what’s on the horizon.

The Doctor Patient Forum says the US FDA should regulate a scoring platform from Bamboo Health intended to help clinicians calculate risk for opioid abuse as a medical device to ensure patient safety.

The US FDA has announced seven device safety actions in recent days. The most serious, which relates to a manufacturing defect in Boston Scientific’s Accolade pacemaker, has been linked to 832 injuries and two deaths.

EU regulators have approved a strategy to streamline the submission and approval of studies that involve the simultaneous investigation of a medicinal product, an IVD, and/or a medical device. The strategy involves rolling out seven cross-sector projects over the next few years.

This week, a medical group sued the FDA to block a lab-developed test rule; the FDA published guidance on device classifications; Defibtec issued a recall of its chest compression device and ICU Medical updated instructions for its infusion pump batteries; Maui Imaging raised a $4m DOD grant to put imaging tech into military-based trauma units.

Through this partnership, data stored in LibreView – Abbott’s cloud-based diabetes data management system – can automatically flow into Epic, allowing clinicians using Epic to view a patient’s CGM data before, during and after visits without toggling between systems or requesting manual uploads.

Diabetes company Insulet announced that former longtime J&J executive Ashley McEvoy will succeed Jim Hollingshead as president and CEO effective today. Analysts applauded the appointment, noting McEvoy’s strong background in medtech and diabetes.

Biolinq plans to use the proceeds of its new venture funding to support US FDA de novo review, automation engineering and commercialization efforts with partners, CEO Rich Yang told Medtech Insight.

Only 14% of people with type 2 diabetes use continuous glucose monitors, although 93% of users report a positive impact on their health. Dexcom is ramping up efforts to close this adoption gap.

Back-to-back meetings at LSX? No time to attend the innovator showcase? Here is what you might have missed from medtech innovators at the LSX World Congress Europe on 29 April.

While Roche continues to view China as a strategic growth market, a sharp 23% decline in Chinese diagnostics sales offset gains in other regions and segments. Despite near-term headwinds, Roche is betting on strong instrument placement growth across its Core Lab, Molecular, and Near Patient Care segments to fuel future demand for consumables and services–key components of its long-term medtech strategy.

Medtech Insight sat down with Jared Bunch, chair of AF Center of Excellence Task Force, at HRS 2025 to discuss the newly HRS released framework for Afib Center of Excellence and get his perspective on the role industry could play to help clinicians improve patient outcomes.

Vendor exhaustion, insufficient clinical-grade evidence, and outdated risk management are some of the reasons the NHS is struggling to adopt AI. Haris Shuaib, CEO of Newton's Tree, shared his insights with the audience at the “Next Frontier of Medical AI” event held at DAC Beachcroft's London office on 23 April.

Freenome plans to file for US FDA approval of its blood-based screening test for colorectal cancer mid-year. If cleared, the test would rival Guardant Health’s Shield, the first FDA-cleared blood test for primary screening of colorectal cancer. Exact Sciences is also in the race to bring a blood-based colorectal screening test to market.

For the fourth time in as many years the FDA has issued a communication concerning a key accessory from Olympus used in several types of urological procedures. This time, however, the agency has added a class I recall confirmation to its original early alert on the device issued in December 2024. A device safety specialist provided Medtech Insight with a deeper understanding of the problem as well as overall scope safety.

The director of the US FDA’s device center is sounding the alarm on the scarcity of critical devices for pediatric patients and says the agency is focused on solutions to this “unique” challenge.

The US FDA has issued its first communication as part of a new pilot program the agency initiated to increase transparency in recalls of high-risk medical devices. The early alerts are meant to minimize the time between the FDA finding out about a potential issue and informing stakeholders.

Q’Apel Medical has pulled its aspiration system for stroke thrombectomy from the market after concerns raised by the US FDA in a February warning letter.

Biolinq plans to use the proceeds of its new venture funding to support US FDA de novo review, automation engineering and commercialization efforts with partners, CEO Rich Yang told Medtech Insight.

The US FDA continues to issue early alerts as part of its communications pilot aimed at improving how the agency manages recalls. This time, the agency is notifying users about two separate intravascular catheters.

The US Medicare agency will hold three public meetings in June and July addressing tremor treatment devices and clinical diagnostic lab tests. The first meeting on June 25 will focus on endpoints for Parkinson’s device trials, while subsequent meetings will address payment rates and codes for laboratory tests.