Nov 20,2024 TOP STORY

Medtronic receives FDA clearance for new InPen™ app, paving the way for its Smart MDI system launch with Simplera™ CGM

Medtronic has received FDA clearance for its new InPen™ app with missed meal dose detection, marking the launch of its Smart MDI (Multiple Daily Injection) system. This system integrates the InPen™ smart insulin pen with the Simplera™ CGM, Medtronic's first disposable, all-in-one continuous glucose monitor. The system provides real-time, personalized dosing recommendations, addressing missed or inaccurate insulin doses—a common challenge for diabetes patients on MDI therapy. It aims to simplify diabetes management, improve glucose control, and reduce health risks. A limited release will begin with existing customers, followed by a broader rollout.

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Nov 14,2024 TOP STORY

FDA Expands the Age Indication for Nerivio® as the First-and-Only REN Wearable for Migraine Treatment for Children Aged Eight and Above

Theranica announced that the Nerivio® REN wearable has received FDA clearance for use in patients aged 8 and above, making it the first FDA-cleared, non-drug treatment for acute migraine in children. The device is now the only prescribed preventive treatment for migraines in this age group. Migraine affects one in 10 children, and this approval provides a safe, effective, and drug-free option, addressing a critical gap in pediatric care. The Nerivio® REN uses remote electrical neuromodulation (REN) to manage migraines by stimulating nerve fibers in the arm, triggering a pain-relieving response in the brain. It offers a much-needed alternative to traditional migraine treatments, which often come with undesirable side effects.

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Oct 30,2024 TOP STORY

ABBOTT'S FREESTYLE LIBRE® 2 AND 3: FIRST CONTINUOUS GLUCOSE MONITORING SYSTEMS APPROVED FOR USE DURING MEDICAL IMAGING

Abbott announced that its FreeStyle Libre 2 and 3 continuous glucose monitoring (CGM) systems have received FDA clearance for use during common imaging procedures like X-rays, CT scans, and MRIs, making them the first CGM systems approved for this use. Previously, patients had to remove and discard their CGM sensors before imaging, causing data gaps and added costs. The updated clearance allows patients to maintain continuous glucose monitoring throughout these procedures, supporting uninterrupted diabetes management and improving convenience and affordability. Abbott’s rigorous testing ensured sensor efficacy post-imaging, reflecting its dedication to accessible diabetes care innovations.

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May 28,2024

Terumo Cardiovascular Announces 510(K) Clearance For The CDI OneView™ Monitoring System All-new modular, expandable design displays up to 22 vital patient parameters with real-time convenienc...

Terumo Cardiovascular, a global leader in cardiovascular surgery technologies, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the CDI OneView Monitoring System. The next-generation CDI Systems platform provides visibility of key patient parameters during cardiopulmonary bypass surgery, critical to perfusion safety and improving patient outcomes.

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Sep 30,2024

MCRA Supports CamDiab with FDA Approval for Artificial Pancreas Software

MCRA, a leading Clinical Research Organization (CRO), assisted CamDiab in securing FDA clearance for their artificial pancreas app, CamAPS FX. The app, designed for managing type 1 diabetes, uses a hybrid closed-loop system that connects a continuous glucose monitor and insulin pump to regulate glucose levels automatically. MCRA's expertise in digital health and quality assurance, along with an innovative pre-determined change control plan (PCCP), enabled smoother software updates. This FDA approval marks a major step forward in diabetes management technology, offering improved care for users, including pregnant women and young children.

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Sep 17,2024

Philips announces FDA approval for enhanced LumiGuide guidewire and marks the 1000th patient treated with its breakthrough 3D device guidance technology

Royal Philips has introduced a 160cm FDA-approved version of its LumiGuide endovascular navigation wire, featuring the company’s Fiber Optic RealShape (FORS) technology. The enhanced guidewire was recently used in the U.S. for the first time during a complex aortic aneurysm repair, marking the 1,000th patient treated with FORS since its 2020 launch. LumiGuide allows physicians to navigate catheters in 3D and color with minimal radiation, reducing procedure time by 37% and X-ray use by 70%. This new version extends its capabilities, offering broader catheter compatibility and improved navigation for complex procedures. The innovation won the 2024 Red Dot Design Award for revolutionizing minimally-invasive surgery guidance.

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Sep 16,2024

Withings Sleep Rx Mat receives FDA 510(k) clearance

Withings, a connected health technology company, announced that its Sleep Rx Mat, a noninvasive, contactless device for diagnosing sleep apnea at home, has received FDA 510(k) clearance. The Sleep Rx Mat uses a pneumatic sensor to measure respiratory rate, body movement, heart rate, sleep cycles, and snoring, providing more precise sleep apnea diagnosis. Antoine Robiliard, VP of Withings Health Solutions, highlighted the importance of long-term sleep monitoring beyond one-night assessments. In 2023, Withings also launched U-Scan, a device for urine biomarker analysis, and in 2022, partnered with Medable to support decentralized clinical trials with its remote monitoring devices.

 

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Sep 16,2024

Apple receives FDA clearance for sleep apnea and hearing aid technology

Apple has received FDA clearance for two new health features: sleep apnea detection in the Watch Series 10 and over-the-counter hearing aid functionality in AirPods Pro. The Watch measures sleep apnea risk using a "Breathing Disturbances" metric, analyzing sleep data every 30 days via software and machine learning. If apnea is detected, users receive a report to share with their doctor. AirPods Pro now include hearing aids that adjust to users' needs after a five-minute hearing test via iPhone. These innovations follow the FDA's 2022 rule on over-the-counter hearing aids, part of a growing trend in home health tech.

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Sep 03,2024 TOP STORY

embecta Announces FDA Clearance of its Disposable Patch Pump for Insulin Delivery Informed by the Unique Needs of People with Type 2 Diabetes

Embecta announced it has received 510(k) clearance from the FDA for its proprietary disposable insulin delivery system. The system includes a wearable, fully disposable patch pump that provides adjustable basal and bolus insulin for up to three days, depending on the needs of the user. The patch pump features a 300-unit insulin reservoir that accommodates people who have higher daily insulin needs, which is typically true of people with T2D. For such people, the on-market patch pumps may not hold enough insulin to meet their needs for three days. In addition to the patch pump, the system comprises a locked-down controller featuring Bluetooth® wireless technology with a color touchscreen designed to create a simplified interface and user experience.

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Aug 26,2024

FDA Clears First Device to Enable Automated Insulin Dosing for Individuals with Type 2 Diabetes

the U.S. Food and Drug Administration expanded the indications of the Insulet SmartAdjust technology, an interoperable automated glycemic controller previously indicated for the management of type 1 diabetes in individuals two years and older, to also include management of type 2 diabetes in individuals 18 years and older. An interoperable automated glycemic controller is software that automatically adjusts insulin delivery to a person with diabetes by connecting to an alternate controller-enabled insulin pump (ACE pump) and integrated continuous glucose monitor (iCGM).

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