- 441MarketSource · MedCity News
Eli Lilly Makes Another In Vivo Genetic Medicines Move With $3.2B Kelonia Acquisition
Eli Lilly acquired Kelonia Therapeutics for $3.2 billion to add an in vivo cell therapy program targeting multiple myeloma. The deal marks Lilly's third genetic medicines acquisition in as many years, following purchases of Verve and Orna Therapeutics, as the pharmaceutical giant diversifies its approach to in vivo genetic therapy across multiple platforms and disease targets.
- 442RegulationSource · Medical Design & Outsourcing
Regulatory tips from a breakthrough noninvasive device startup
Compremium's Quantis CVP, a noninvasive central venous pressure measurement device, received FDA Breakthrough Device designation in January 2026 and was enrolled in the FDA's Total Product Life Cycle Advisory Program (TAP). The program provides regulatory guidance to accelerate development of high-priority medical devices. The designation and TAP enrollment support expedited patient access pathways for the device.
- 443New productsSource · Medical Design & Outsourcing
Freudenberg Medical launches ISO Class 5 cleanroom for biopharma
Freudenberg Medical announced CleanAssure, a new ISO Class 5 controlled cleanroom facility for processing sterile single-use assemblies in biopharma manufacturing. The service combines cleaning and sterilization capabilities to deliver ready-to-use components to customers, expanding Freudenberg's contract manufacturing and design offerings in the single-use systems market.
- 444New productsSource · Medical Design & Outsourcing
How ZB’s Paragon 28 created a novel curved foot nail system
Zimmer Biomet's Paragon 28 division has launched a novel curved foot nail system designed to better match foot and ankle anatomy. The implant required development of three new instruments alongside the device itself. The innovation addresses surgical fixation for foot and ankle procedures.
- 445New productsSource · Medical Design & Outsourcing
The first year-long CGM implant developer isn’t done yet
Senseonics launched Eversense 365, the first implantable continuous glucose monitor (CGM) designed to function for a full year, in 2024. Unlike transcutaneous rivals from Abbott and Dexcom that use small needles to measure interstitial glucose, the Eversense system uses a different sensing approach. The company is advancing the implantable CGM category as a differentiated alternative in the glucose monitoring market.
- 446TechnologySource · Medical Design & Outsourcing
Microstructure makes ePTFE a versatile medtech material
Expanded polytetrafluoroethylene (ePTFE) is a widely used material in medical devices with applications including vascular grafts and stent coatings. The material's versatility stems from its microstructure, which can be engineered in multiple forms to deliver varying properties such as chemical inertness, biocompatibility, flexibility, and durability. Understanding these structural variations is important for device engineers selecting ePTFE for specific applications.
- 447MarketSource · Medical Design & Outsourcing
Abbott’s device leader pay climbs again with double-digit sales growth
Abbott's EVP and Medical Devices Group President Lisa Earnhardt received a compensation package increase exceeding 20% in 2025, reflecting double-digit sales growth in the division. Abbott ranked eighth globally among medical device companies by revenue in the latest Medtech Big 100 rankings. The pay rise underscores strong financial performance in the device segment amid broader market momentum.
- 448New productsSource · Medical Design & Outsourcing
MiniMed flexes with next-gen insulin pump after spinning off from Medtronic
MiniMed, recently spun off from Medtronic via March IPO, secured FDA clearance for its next-generation MiniMed Flex automated insulin delivery system. The screenless, compact pump represents a product advancement for the standalone diabetes-device company and signals continued R&D investment in its core insulin-delivery portfolio following the separation from its former parent.
- 449New productsSource · Medical Design & Outsourcing
BMF launches clear resin for transparent micro 3D printing
Boston Micro Fabrication introduced BMF Clear resin, enabling optical transparency in micro-precision 3D printing. The material addresses manufacturing gaps for microfluidic devices and optical components, enabling applications such as direct printing of micro-lenses onto fiber optic tips and sensor surfaces. The resin expands scalable production options for previously difficult-to-manufacture medical device components.
- 450MarketSource · Medical Design & Outsourcing
Switchback Medical is expanding into Costa Rica
Switchback Medical, a medical device contract development and manufacturing organization, has signed a lease for an 18,000-square-foot facility in Costa Rica's Coyol Free Trade Zone. The expansion marks the company's first international manufacturing footprint outside its Brooklyn Park, Minnesota headquarters, signaling a strategic shift in production capacity and supply-chain positioning for the CDMO sector.
- 451MarketSource · Medical Design & Outsourcing
CDMO Arterex upgrades manufacturing facility near Boston
Arterex, a contract device manufacturer, is expanding its Mansfield, Massachusetts facility by 15,000 square feet and installing a new steam sterilizer to boost operational capacity by nearly 50%. The upgrade aims to improve inventory control and logistics efficiency for its contract manufacturing customers.
- 452MarketSource · Medical Design & Outsourcing
Medtech CDMO Integer discloses executive pay after new CEO steps in
Integer Holdings Corp., a contract manufacturer and CDMO for medical devices, disclosed executive compensation packages following a new CEO appointment in an SEC filing. The company also reported a significant increase in median employee pay. Integer ranks among the top 60 medical device companies globally.
- 453MarketSource · Fierce Healthcare
Whoop raises $575M series G, Abbott comes on board amid hiring spree
Whoop, a fitness wearable maker, raised $575 million in Series G funding with Abbott as a new investor. The round comes as Whoop expands hiring and positions itself for growth in the consumer health monitoring space. Abbott's participation signals potential distribution or integration opportunities between the companies.
- 454TechnologySource · Fierce Healthcare
UPDATED: Stryker hit by international cyberattack linked to pro-Iran group
Stryker Corporation experienced a significant cyberattack attributed to a pro-Iran threat actor that resulted in data wiping across enterprise systems and disrupted employee access. The incident highlights vulnerabilities in medical device manufacturer IT infrastructure and raises questions about business continuity for a major surgical equipment and orthopedic devices supplier. Stryker supplies hospitals and surgical centers globally with imaging systems, surgical instruments, and hospital beds.
- 455TechnologySource · Fierce Healthcare
Quest Diagnostics launches Google-powered AI chatbot to help patients understand lab results
Quest Diagnostics launched an AI-powered chatbot built on Google technology to help patients interpret laboratory test results. The tool allows customers to query their findings and access health insights independently. The move represents a digital engagement strategy by a major clinical laboratory vendor to enhance patient-facing services and differentiate its lab services platform.
- 456New productsSource · Fierce Healthcare
Hims & Hers to sell Grail’s Galleri multi-cancer blood test via its digital health platform
Hims & Hers, a telehealth platform, has begun offering Grail's Galleri multi-cancer blood test through its digital health service. Galleri is a cell-free DNA screening test designed to detect multiple cancer types from a single blood draw. The partnership expands access to the test via Hims & Hers' existing patient base and distribution channels, marking a move by the telehealth vendor into cancer screening diagnostics.
- 457MarketSource · Fierce Healthcare
Medline makes Nasdaq debut, raising $6.26B in year's largest IPO
Medline Industries completed its Nasdaq initial public offering, raising $6.26 billion in the largest IPO of 2024. The medical device and supply distributor, previously held by private equity, transitions to public ownership. The offering marks a significant milestone for one of the U.S.'s largest medical equipment and consumables vendors and signals investor appetite for established medical-supply businesses.
- 458MarketSource · Fierce Healthcare
GE HealthCare to acquire imaging software provider Intelerad for $2.3B
GE HealthCare announced a $2.3 billion acquisition of Intelerad, a cloud-based imaging software provider serving radiology, cardiology, and clinical trial workflows. The deal expands GE HealthCare's outpatient imaging portfolio and complements its existing in-hospital imaging infrastructure. Intelerad's platform serves independent practices and healthcare networks with DICOM viewing, management, and AI-enabled analysis tools.
- 459MarketSource · Fierce Healthcare
Abbott dives into cancer diagnostics with $23B buyout of Exact Sciences
Abbott announced a $23 billion acquisition of Exact Sciences, the developer of Cologuard and blood-based cancer screening tests. The deal marks the largest diagnostics acquisition to date and significantly expands Abbott's oncology diagnostic portfolio, combining Exact Sciences' colorectal and multi-cancer detection platforms with Abbott's existing diagnostic infrastructure and distribution capabilities.
- 460New productsSource · Fierce Healthcare
Apple aims to catch 1 million hypertension cases in one year with new Apple Watch
Apple launched a blood pressure monitoring feature on its latest Apple Watch model, designed to detect hypertension cases at scale. The feature uses the existing pulse-rate sensor to measure blood vessel response to heartbeats. Apple projects the capability could identify approximately 1 million undiagnosed hypertension cases within the first year of deployment, positioning the device as a consumer-grade screening tool for cardiovascular risk.
- 461MarketSource · Fierce Healthcare
Tempus claims AI pathology developer Paige in $81M deal
Tempus acquired AI pathology developer Paige for $81 million, gaining access to a dataset of nearly 7 million digitized pathology slides and associated clinical data from Memorial Sloan Kettering Cancer Center. The acquisition adds Paige's machine-learning capabilities in digital pathology to Tempus's oncology-focused platform.
- 462MarketSource · Fierce Healthcare
Philips to invest $150M in US manufacturing base, including ultrasound site expansion
Philips announced a $150 million investment in its U.S. manufacturing footprint, including expansion of a Pennsylvania facility dedicated to hospital ultrasound equipment production. The move reflects the company's strategy to strengthen domestic manufacturing capacity for imaging hardware.
- 463MarketSource · Fierce Healthcare
Ultromics nets $55M to boost its AI ultrasound software for detecting hidden heart failure
Ultromics secured $55 million in venture funding to scale its AI-driven ultrasound software platform for detecting occult heart failure. The funding will support commercial expansion of the company's diagnostic tools, which use machine learning to identify cardiac abnormalities from echocardiography images that may be missed by conventional analysis.
- 464RegulationSource · Fierce Healthcare
FDA clears first AI tool for breast cancer risk prediction from startup Clairity
The FDA cleared Clairity's AI tool for predicting five-year breast cancer risk from routine mammograms, marking the first FDA-cleared application of this kind. The software analyzes screening mammograms to generate individualized risk assessments, enabling radiologists and clinicians to tailor follow-up protocols and patient management strategies based on quantified risk levels.