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MedTech Dive Trendline on New medical devices are reshaping the medtech industry
Johnson & Johnson announced that its Ottava robotic surgery system has received FDA de novo authorization for use in multiple general surgery procedures, marking the arrival of another heavyweight competitor in the U.S. soft tissue surgical robot market.
Abbott receives FDA nod for dual-analyte sensor
Abbott's Libre Duo 10 Day sensor has received FDA authorization, becoming the world's first continuous monitoring technology for dual markers (blood glucose and ketones). The device is suitable for people with diabetes aged 2 years and older, can be worn for 10 days, and is planned to launch in the U.S. this year.
Qiagen names new CEO
Qiagen announced on Monday the appointment of Jonathan Pratt as CEO, concluding a nearly 10-month search for a successor. Pratt, formerly President and CEO of Filtration Group, brings extensive experience in analytical instruments and life sciences, and will officially take office on September 1.
Roche, Eli Lilly get FDA nod for new Alzheimer’s blood test
Roche announced Monday that the FDA cleared its Elecsys pTau217 blood test, developed with Eli Lilly, for assessing Alzheimer's disease. The test measures a single biomarker to help rule in and rule out amyloid pathology in adults 55 and older with cognitive decline. Labcorp and Quest Diagnostics will offer the test, which follows recent FDA clearances of other Alzheimer's blood tests, signaling growing competition in the diagnostics market.
FDA adds two behavioral health firms to TEMPO pilot
The FDA announced that Limbic and Sondermind have joined the TEMPO digital health device pilot, bringing the total to four participating companies. Limbic offers the AI mental health service Unpacked, while Sondermind has launched an adjunctive therapy app, both of which can be provided to patients through the new Medicare payment model.
MiniMed starts shipping new insulin pump with Abbott-made sensor
MiniMed announced last week that its new MiniMed Flex insulin pump has begun shipping in the U.S., paired with the Instinct sensor manufactured by Abbott. The sensor can be used for up to 15 days. The company stated that this shipment combines the smallest app-only-controlled insulin pump with the world's smallest sensor. To support the launch, MiniMed initiated its first major marketing campaign for insulin pumps.
Siemens Healthineers and Philips receive ARPA-H funding to advance autonomous robotics for stroke treatment
ARPA-H announced up to $175.3 million in funding to companies and universities, including Siemens Healthineers and Philips North America, to develop autonomous intravascular robots to expand timely treatment coverage for stroke patients. Siemens Healthineers will receive $31.1 million, and Philips will receive $33.7 million, with the project aiming to reduce accessibility gaps in thrombectomy procedures through remote robotic technology.
Baxter Appoints Smith & Nephew CFO John Rogers as New Finance Chief
Baxter announced Wednesday that John Rogers will join as executive vice president and CFO on Oct. 1, succeeding interim CFO Anita Zielinski. Rogers, who has served as Smith & Nephew's CFO since 2024, brings experience in medtech and corporate turnarounds. His appointment comes as Baxter continues a multiyear restructuring, including recent divestitures of its biopharma solutions and kidney care businesses.
GE HealthCare appoints William Grogan as permanent CFO
GE HealthCare said Tuesday it has appointed William Grogan as CFO, filling the vacancy left by Jay Saccaro's departure last month. Grogan joins from Xylem, where he served as CFO since October 2023. He will leave Xylem on Sept. 13 and start at GE HealthCare the following day. Analysts at Stifel and RBC Capital Markets welcomed the move, citing Grogan's track record of meeting earnings expectations, expanding margins, and integrating acquisitions.
5 questions on Abbott’s glucose-ketone sensors
Abbott is preparing to introduce Libre Duo, a dual glucose-ketone sensor, to the U.S. market after receiving CE mark in Europe. The device targets people with diabetes at risk for diabetic ketoacidosis. While experts see potential in continuous ketone monitoring, questions remain about target users, clinical utility, data overload, education, and pricing. Breakthrough T1D has published consensus recommendations, but individualized thresholds and clear guidelines are still evolving.